CER For Oticon More

Clinical Evaluation Report
Title: Document No. Revision No. Page No.

Clinical Evaluation Report for 0901c76e809e80a6 See change 1 of 285
HI-QMS Hearing Aid – Oticon More log
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Clinical Evaluation Report for

Hearing Aid – Oticon More
Written by:
Name Title/Role & Function Signature Date
Christina Degn Frary Clinical Audiologist, CAU CHNF 2020-12-14
Lars Bramsløw Audiological Researcher/ERH LABW 2020-12-14
Joanna Rzędzian Clinical Audiologist/SWS JOZD 2020-12-14
Eva Andreasson Clinical Audiologist/SWS EVAA 2020-12-14
Dragan Gusatovic Clinical Audiologist/CAU DRGU 2020-12-14
Louise Würtz Jørgensen Regulatory Affairs Manager/ LOUJ 2020-12-14

QARA
Reviewed by:
Regulatory Affairs Project

Christina Bach Pilegaard CSOH 2020-12-14
leader/ QARA
Henrik Lodberg Olsen Clinical Audiologist/CAU HEOL 2020-12-14
Monika Baumann Clinical audiologist, PMCF MOBM 2020-12-14

responsible/CAAR
Approved by:
Thomas Behrens Chief of Audiology, Oticon THBE 2020-12-15
Template for: Clinical Evaluation Report, 888 18 001 Rev. 3.0

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Change log:
Revision No. Date Writer Change
1.0 2020-09-10 LBHA Document created on behalf of CHNF

2.0 2020-12-14 THBE Updated to cover 20.2 release.
3.0 2020-12-15 CHNF Updated footer, no need for review

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Executive summary
This Clinical Evaluation Report (CER) was conducted following the Clinical Evaluation Plan (CEP) number
0901c76e809e8029. Both documents were prepared according to the Medical Device Regulation (MDR)
2017/745 and MEDDEV 2.7/1 revision 4.
The aim of this Clinical Evaluation is to establish conformity of the Oticon More 1 miniRITE R wireless hearing
aid (henceforth referred to as “device under evaluation”) to the MDR Annex 1 General Safety and
Performance Requirements (GSPRs). The device is classified as Class IIa according to Rule 9 of the MDR
2017/745 Annex VIII. This Clinical Evaluation also covers Class II accessories of the More 1 hearing aid,
namely the fitting software, Oticon Genie 2, the remote fitting app, Oticon RemoteCare App, and the remote
control app, Oticon ON App; as well as Class I devices - a charger and the optional accessories: remote
control, TV adapter, Phone Adapter, EduMic and a streaming gateway. The remote fitting app is intended to
be used by adults above 18 years old. All other devices are intended to be used by adults and children aged ≥
36 months with hearing impairment in severity from mild to severe-to-profound. The only exception is the
fitting software, which are applied by a hearing care professional to fit the device to the patient’s needs.
The device under evaluation is equivalent to an existing family of Oticon hearing instruments currently on the
market, which correspond to the state-of-the-art products and are similar with competitors’ devices
regarding performance and safety of use. Oticon Opn S family was launched in 2019 (under MDD), with
approximately 1.400.046 units sold worldwide so far and used as an equivalent device within this document.
The present clinical evaluation was based on clinical data from the literature and safety databases on the use
of wireless hearing aids and similar devices from the same or other manufacturers, data from clinical
investigations on the device under evaluation, as well as post-market surveillance (PMS) and bench-testing
data in compliance to applicable standards of the device under evaluation.
The underlying technology of the Oticon More 1 wireless hearing aids is well established. The devices are
intended to amplify and transmit sound to the ear and hereby compensate for the hearing loss. Known risks
(e.g. amplification of the sound to levels that are too high, swallowing of the battery) have been mitigated by
risk control measures, and residual risks are considered acceptable. No new hazards or hazardous situations
were identified in the device-specific or the state-of-the-art literature searches nor in safety databases.
When used for the intended purpose in the target population, the benefit of using the device under
evaluation clearly outweighs the risks to the patient.
The presented preclinical and clinical data on our own wireless hearing aids, the technical characteristics and
safety data from similar CE-marked devices under MDD and the literature review allow us to conclude that
the Oticon More 1 wireless hearing aids perform as good and satisfactory as any other wireless hearing
instruments on the market. Oticon More 1 fulfills the requirements given in the intended use, i.e. to amplify

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and transmit sound to the ear and thereby to compensate for impaired hearing, which is expectedly
comparable to similar products on the market.
Based on the literature review, the outcome of our own clinical studies, the number of complaints on
equivalent devices, and the management of risks, it can be concluded that Oticon More 1 is safe to use for
the intended purpose. No new safety issues have been seen from any wireless hearing aids, neither from
Oticon nor the competitors. Therefore, we can conclude that Oticon More 1 has a favorable benefit-risk
profile.
In summary, the reviewed clinical evidence substantiates compliance of the Oticon More 1 devices with the
General Safety Performance Requirements of Annex I in the Medical Device Regulation (EU) 2017/745.

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Table of Contents
Executive summary........................................................................................................................... 4
Reference documents ..................................................................................................................... 15
Definitions and abbreviations .......................................................................................................... 15
1 Purpose ................................................................................................................................... 17
General safety and performance requirements ..................................................................... 17
2 Scope of clinical evaluation ...................................................................................................... 18
Identification of device .......................................................................................................... 18
Identification of manufacturer ............................................................................................... 19
Device description ................................................................................................................ 19
2.3.1 Hearing aid...................................................................................................................................... 19
2.3.2 Mechanical design .......................................................................................................................... 21
2.3.3 Principles of operation .................................................................................................................... 23
2.3.4 Key technical features .................................................................................................................... 25
2.3.5 Hearing aid material (biological safety) .......................................................................................... 25
2.3.6 Device design history ...................................................................................................................... 28
2.3.1 Number of devices on the market ................................................................................................... 30
Classification ........................................................................................................................ 31
Intended use, indications for use and intended user ............................................................. 31
Body parts that interact with the device ................................................................................ 32
Contraindications and limitations .......................................................................................... 32
Side effects .......................................................................................................................... 33
Warnings .............................................................................................................................. 33
2.9.1 Important Notices ............................................................................................................................ 36
Expected lifespan ............................................................................................................. 37

Product life-cycle .............................................................................................................. 37
Device claims.................................................................................................................... 37
2.12.1 Intended clinical benefit to patients ................................................................................................ 39
Accessories ...................................................................................................................... 40

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2.13.1 Fitting software Genie 2 .................................................................................................................. 41
2.13.1 Oticon RemoteCare App (optional)................................................................................................. 48
2.13.2 Oticon ON App (optional) ................................................................................................................ 50
2.13.3 Oticon Charger................................................................................................................................ 51
2.13.4 Oticon TV adapter (optional)........................................................................................................... 54
2.13.5 Oticon Phone Adapter 2.0 (optional) .............................................................................................. 55
2.13.6 Oticon ConnectClip (optional) ......................................................................................................... 56
2.13.7 Oticon EduMic (optional) ................................................................................................................ 57
Equivalent device.............................................................................................................. 58
3 Clinical background, current knowledge, state of the art .......................................................... 73
Hearing impairment .............................................................................................................. 73
3.1.1 Clinical Background ........................................................................................................................ 73
3.1.2 User Groups and treatments options .............................................................................................. 75
3.1.3 Hearing aids .................................................................................................................................... 77
3.1.4 Hearing aid description ................................................................................................................... 81
3.1.5 Hearing aid fitting management ...................................................................................................... 81
3.1.6 Hearing Aid Performance and benefit ............................................................................................ 87
Tinnitus ................................................................................................................................ 89
3.2.1 Clinical background ........................................................................................................................ 89
3.2.2 User Groups and treatments options .............................................................................................. 90
3.2.3 Therapeutic options ........................................................................................................................ 90
3.2.4 Sound therapy................................................................................................................................. 93
3.2.5 Tinnitus management ..................................................................................................................... 96
3.2.6 Audiological approaches to sound therapy ..................................................................................... 99
3.2.7 Sound therapy support performance and benefit ......................................................................... 101
Identification of pertinent data and appraisal criteria used .................................................. 103

Applicable standards and guidelines .................................................................................. 103
State-of-the-art benefit-risk analysis ................................................................................... 104
3.5.1 Hearing impairment ...................................................................................................................... 104

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3.5.2 Tinnitus ......................................................................................................................................... 106
Clinical risks associated with the device ............................................................................. 107

Level of evidence to demonstrate conformity with GSPRs.................................................. 107
4 Risk management .................................................................................................................. 108
5 Summary of identified data .................................................................................................... 109
Preclinical data ................................................................................................................... 109
Clinical data of hearing device ............................................................................................ 110
5.2.1 Equivalent device .......................................................................................................................... 110
5.2.2 Device under evaluation ............................................................................................................... 112
Clinical Data of Tinnitus SoundSupport feature .................................................................. 115

Post-market surveillance data ............................................................................................ 118
5.4.1 Complaints .................................................................................................................................... 118
Post-market clinical follow-up data ..................................................................................... 123

Safety data ......................................................................................................................... 127
5.6.1 MAUDE search ............................................................................................................................. 127
5.6.2 TGA search ................................................................................................................................... 139
5.6.3 MHRA search................................................................................................................................ 140
5.6.4 Health Canada search .................................................................................................................. 140
5.6.5 BfArM Search................................................................................................................................ 140
5.6.6 Summary ....................................................................................................................................... 141
Performance and safety data retrieved from the literature .................................................. 141
5.7.1 Hearing aids for adults .................................................................................................................. 143
5.7.2 Hearing aids for children ............................................................................................................... 147
5.7.3 Unilateral fitting ............................................................................................................................. 148
Performance and safety data retrieved from the literature - Tinnitus ................................... 150
5.8.1 Tinnitus relief with combination instrument ................................................................................... 152
6 Appraisal of pertinent data ..................................................................................................... 154

7 Analysis of the clinical data .................................................................................................... 155
Safety ................................................................................................................................. 155

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Performance....................................................................................................................... 168
Side effects ........................................................................................................................ 171
Benefit-risk profile............................................................................................................... 172
Lifecycle considerations ..................................................................................................... 175
8 Conclusions ........................................................................................................................... 176
9 Date of the next clinical evaluation ......................................................................................... 177
10 Qualification of evaluators ...................................................................................................... 178
11 Appendices ............................................................................................................................ 181
Appendix A: References ................................................................................................. 181
11.1.1 Retrieved literature (all searches) ................................................................................................. 181
11.1.2 General references ....................................................................................................................... 188
Appendix B: Internal documents ..................................................................................... 194

11.2.1 Pre-clinical Data ............................................................................................................................ 194
11.2.2 Clinical Data .................................................................................................................................. 194
11.2.3 Classification and Intended Use ................................................................................................... 194
11.2.4 Risk management documents ...................................................................................................... 195
11.2.5 Instruction for Use ......................................................................................................................... 196
11.2.6 Post-Market activitites ................................................................................................................... 197
Appendix C – Commercial feature overview ................................................................... 198

Appendix D: Data collection report for wireless hearing aid technology .......................... 200
11.4.1 Data collection .............................................................................................................................. 200
11.4.2 Data selection ............................................................................................................................... 201
11.4.3 Additional search on SSQ ............................................................................................................. 202
11.4.4 Data selection ............................................................................................................................... 203
Appendix E: Data collection report for equivalent devices ............................................... 204

11.5.1 Purpose and scope ....................................................................................................................... 204
11.5.2 Data sources ................................................................................................................................. 204
11.5.3 Inclusion criteria ............................................................................................................................ 204
11.5.4 Exclusion criteria ........................................................................................................................... 205

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Data selection ................................................................................................................. 206

Appendix F: Data collection report for hearing aid fitting management (HAFM) .............. 206
11.7.2 Data sources ................................................................................................................................. 207
11.7.5 Data selection ............................................................................................................................... 209
11.7.6 Adults ............................................................................................................................................ 209
11.7.7 Children ......................................................................................................................................... 210
Appendix G: Data collection report for tinnitus management program ............................. 211
11.8.2 Data sources ................................................................................................................................. 211
11.8.5 Data selection ............................................................................................................................... 213
Appendix H: Data collection report for safety and performance endpoints ...................... 214
11.9.2 Data sources ................................................................................................................................. 214
11.9.5 Performance variables .................................................................................................................. 216
11.9.6 Safety variables ............................................................................................................................ 216
11.9.7 Search strategy and selection ...................................................................................................... 216
11.9.8 Performance domains ................................................................................................................... 222
11.9.9 Data appraisal ............................................................................................................................... 222
11.9.1 Review of publications .................................................................................................................. 226
11.9.2 Critical evaluation of literature data .............................................................................................. 226
Appendix I: Data collection report for safety and performance endpoints – tinnitus sound
therapy support ........................................................................................................................... 227
11.10.1 Purpose and scope ................................................................................................................... 227

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11.10.2 Literature collection ................................................................................................................... 227
11.10.3 PubMed Search strategy and selection .................................................................................... 229
11.10.4 Data appraisal ........................................................................................................................... 232
Appendix J: Overview of publications .......................................................................... 235

11.11.1 Wireless hearing aids ............................................................................................................... 235
11.11.2 Tinnitus ..................................................................................................................................... 270
List of Tables
Table 1: Definitions and abbreviations ............................................................................................ 15
Table 2: Parts of the More 1 ............................................................................................................ 22
Table 3: Materials in contact with body parts................................................................................... 27
Table 4: More miniRITE R hearing aids, time of CE-marking and introduction to market................. 29
Table 5: Fundamentals of use ......................................................................................................... 31
Table 6: Overview of the compatible accessories* for More 1 ......................................................... 41
Table 7: Overview of key characteristics (fitting software) ............................................................... 46
Table 8: Overview of key characteristics (remote fitting app) .......................................................... 49
Table 9: Overview of key characteristics (remote control app) ........................................................ 50
Table 10: Overview of key characteristics (Charger) ....................................................................... 51
Table 11: Overview of key characteristics (remote control) ............................................................. 53
Table 12: Overview of key characteristics (TV adapter) .................................................................. 54
Table 13: Overview of key characteristics (Phone adapter) ............................................................. 55
Table 14 Overview of key characteristics (ConnectClip).................................................................. 56
Table 15. Equivalence table ............................................................................................................ 59
Table 16: Degrees of hearing loss (ASHA, 2020) as specified by the American Speech-Language-
Hearing Association (asha.org), using pure-tone average of 0.5, 1 and 2 kHz. ............................... 74
Table 17. Degrees of tinnitus severity ............................................................................................. 90
Table 18: Overview of treatment options for tinnitus ........................................................................... 91
Table 19: Sound therapy options ....................................................................................................... 91
Table 20: Surgery options ................................................................................................................. 92
Table 21: Drug options ..................................................................................................................... 92
Table 22: Psychological therapy options ............................................................................................. 92
Table 23: Other treatment options for tinnitus .................................................................................... 92
Table 24: Type of sounds................................................................................................................ 95
Table 25: The six elements of tinnitus management ....................................................................... 96
Table 26: Overview of the evidence of five of the most common used treatments for tinnitus. ........ 99
Table 27. Principle of setting level of relief sound.......................................................................... 100
Table 28: Applicable standards and guidelines ............................................................................. 103
Table 29: Clinical data from Opn S 1: Validation ........................................................................... 110
Table 30: Clinical data from Opn S miniRITE R: Usability ............................................................. 110
Table 31: Validation data (V1) from Opn S 1 in terms of performance and safety outcomes ......... 111

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Table 32: Usability data (U1) from Opn S 1 in terms of performance and safety outcomes ........... 112
Table 33: Clinical data from More 1: Validation ............................................................................. 112
Table 34: Clinical data from More 1 miniRITE R: Usability ............................................................ 113
Table 35: Validation data (V2) from More 1 in terms of performance and safety outcomes ........... 114
Table 36: Usability data (U2) from More 1 in terms of performance and safety outcomes ............. 115
Table 37: Clinical data from Alta2 Pro Ti: Validation on tinnitus sound support ............................... 115
Table 38: Clinical data from Opn 1: Validation on tinnitus sound support ...................................... 116
Table 39: Validation data (T1) from Alta2 Pro Ti in terms of performance and safety outcomes for
tinnitus sound support ................................................................................................................... 117
Table 40: Validation data (T2) from Opn 1 in terms of performance and safety endpoints for tinnitus
sound support ............................................................................................................................... 117
Table 41: Endpoints and outcome data to support clinical performance outlined in the IFU .......... 124
Table 42: Adverse Event Reports from MAUDE database ............................................................ 127
Table 43. Adverse Event Reports from MAUDE database related to tinnitus ................................ 138
Table 44: Adverse Event Reports from TGA database .................................................................. 139
Table 45: Adverse Event Reports from MHRA database............................................................... 140
Table 46: Hazards with significant severity.................................................................................... 155
Table 47: Hazards with moderate severity .................................................................................... 159
Table 48: Qualifications of Evaluators ........................................................................................... 179
Table 49: Inclusion criteria ............................................................................................................ 200
Table 50: PubMed search for HAFM ............................................................................................. 200
Table 51: Cochrane search for hearing aid technology ................................................................. 201
Table 52: Results from the state-of-the-art search for hearing aid technology ............................... 201
Table 53 Inclusion Criteria ............................................................................................................ 202
Table 54 Pubmed search for SSQ ................................................................................................ 202
Table 55 ClinicalTrials.gov search for SSQ ................................................................................... 203
Table 56: Results from the state-of-the-art search for SSQ questionnaire ..................................... 203
Table 57 Inclusion criteria................................................................................................................. 204
Table 58. Search in PubMed for equivalent device ....................................................................... 205
Table 59. Search in PubMed Central for equivalent device ........................................................... 205
Table 60. Search in ClinicalTrial.gov for equivalent device............................................................ 206
Table 62: PubMed search for protocols and guidelines ................................................................. 208
Table 63: Cochrane search for protocols and guidelines ............................................................... 208
Table 64: Classification of guidelines for adults ............................................................................. 209
Table 65: Classification of guidelines for children .......................................................................... 210
Table 67: PubMed search for protocols and guidelines ................................................................. 212
Table 71: Search strategy for safety and performance .................................................................. 217
Table 72: Overview of performance domain of the three performance variables used .................. 222
Table 73: Suitability assessment ................................................................................................... 222

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Table 74: Contribution assessment ............................................................................................... 223

Table 75: Weighting scheme for suitability and contribution .......................................................... 223
Table 76: Overview of complete data appraisal ............................................................................. 224
Table 77: Overview of data appraisal findings ............................................................................... 226
Table 78. Exclusion criteria ........................................................................................................... 228
Table 79 Summary of keywords and search results (PubMed)...................................................... 232
Table 80. Suitability evaluation (Best = 1 worst =3) ....................................................................... 232
Table 81. Contribution evaluation (Best = 1 worst =2) ................................................................... 233
Table 82. Weighting scheme for suitability and contribution .......................................................... 233
Table 83. Overview of complete data appraisal ............................................................................. 233
Table 84. Overview of the 10 findings from the data appraisal. ..................................................... 234

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List of Figures
Figure 1: Oticon More 1 miniRITE R ............................................................................................... 20
Figure 2: Position of receiver in ear canal ....................................................................................... 20
Figure 3: Overview of the miniRITE R hearing aid........................................................................... 21
Figure 4: Single components of More 1........................................................................................... 22
Figure 5 Basic elements of a wireless hearing aid........................................................................... 24
Figure 6: Tinnitus SoundSupport module ........................................................................................ 24
Figure 7. Schematic overview of the hearing aid and its associated accessories ............................ 40
Figure 8: Basic elements of a wireless hearing aid .................................................................... 78
Figure 9: Procedural aspect is modeled by a potential flow occurring in the process of HAFM
....................................................................................................................................................... 83
Figure 10: Unaided and aided gain .............................................................................................. 88
Figure 11. Basic elements of a wireless combination instrument..................................................... 94
Figure 12: Schematic flow chart of tinnitus management ................................................................ 97
Figure 13. Audiogram in dB HL ..................................................................................................... 102
Figure 14: Overview of literature search results for adults ............................................................. 142
Figure 15: Overview of literature search results for children. ......................................................... 143
Figure 16. Overview of literature search results for Tinnitus sound therapy................................... 151
Figure 17 Overview of literature search results. The search has been divided into three searches (A1, A2 and
A3) and is separated in the figure with a forward slash “/”. .................................................................. 232

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Reference documents
• Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, and
amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
(MDR)
• MEDDEV 2.7/1 Revision 4 - MEDDEV 2.7/1 revision 4, Clinical Evaluation: a guide for manufacturers
and notified bodies under directives 93/42/EEC and 90/385 EEC
Definitions and abbreviations
Table 1: Definitions and abbreviations

Term Definition
A Adults
APHAB Abbreviated Profile of Hearing Aid Benefit - Questionnaire
BAHA Bone-Anchored-Hearing-Aid
BLE Bluetooth Low Energy
BTE Behind-The-Ear (HA style)
CAAR Centre for Applied Audiology Research
CAU Clinical Audiology & Usability
CBT Cognitive behavioral Therapy
CE Conformité Européenne
CEP Clinical Evaluation Plan
CER Clinical Evaluation Report
CI Cochlear Implant
Clinical Data Safety and performance information generated from the clinical use in human
subjects
CROS Contralateral Routing of Signal
CT Computed tomography
Darwin Name of the miniRITE R HW platform used in the Polaris project in which Oticon
More were developed. Name not used commercially.
dB Decibel
DECS Dynamic Speech Processing
DHF Design history file
DNN Deep Neural Network
EMC Electromagnetic compatibility
ES/eSW Embedded software
FOG Full-on Gain
fSW Fitting Software
FW Firmware (deep-layer software)
Genie 2 Oticon fitting software
GHz Giga Hertz
GOP General Operational Procedure
GSPR General Safety and Performance Requirements
HA/HI Hearing Aid/Hearing Instrument

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HAFM Hearing Aid Fitting Management

HCP Hearing Care Professional (hearing aid professional, audiologist, ENT (ear, nose and
throat) doctor, and hearing specialist ) is a person who is appropriately educated
and has proven competency in professionally assessing hearing, selecting, fitting
and delivering hearing instruments and rehabilitation care to persons with hearing
loss. 1
HIG Hearing Instrument Group
HL Hearing Level/Hearing Loss
HW Hardware
IFU Instructions for Use
IOI-HA International Outcome Inventory for Hearing Aids - Questionnaire
kHz Kilo Hertz
LED Light Emitting Diode
Li-ion Lithium-ion
M1-M5 Milestones
Magneto Name of the miniRITE T R HW platform used in the Marvel project in which both
Opn S and More were developed. Name not used commercially.
Marvel Development project in Demant HIG including Ruby and Opn S
MNR miniRITE
Model 1 Oticon hearing aids on a given processing platform from Demant HIG
Model 2 Philips, Bernafon and Sonic hearing aids on a given processing platform from
Demant HIG
More 1 Oticon hearing aid
MPO Max Power Output
MR Magnet resonans
NA, N/A, n/a Not applicable
NFMI Near Field Magnetic Induction
NH Normal hearing
Opn S 1 Oticon hearing aid
p Probability value for a statistical model
PMCF Post-market clinical follow-up
PMS Post Market Surveillance
Polaris Development project in Demant HIG including Oticon More
Price points Segmentation of products based on price range determined by the provided set of
features in the Product Model.The higher the price point, the more features
available when buying a hearing instrument.
PP Plus power
PTA4 Pure Tone Average for the frequencies 500, 1000, 2000 and 4000 Hz
QARA Quality Assurance & Regulatory Affairs
QSP Quality Surveillance Program
R Rechargeable
RC App Remote Control App
REM Real-Ear Measurement
RF Radio Frequency
1 Job title may vary from country to country.

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RF App Remote Fitting App

RITE Receiver-In-The-Ear (HA style)
RU Response unit
Ruby Oticon hearing aid
SADL Satisfaction with Amplification in Daily Life - Questionnaire
SD Standard Deviation
SII Speech intelligibility index
SNR Signal to Noise Ratio
SOP Standard Operational Procedure
SPL Sound Pressure Level
SW Software
SWS Software solution
T Telecoil
TF/MDF Technical File/Medical Device File
TSS Tinnitus Sound Support
TSS Tinnitus Sound Support
WLP Wireless Link Prioritization
WDRC Wide Dynamic Range Compression
Y Years
1 Purpose
The aim of this Clinical Evaluation is to confirm safety and performance of the Oticon More 1 wireless
hearing aid to demonstrate conformity with the General Safety and Performance Requirements (GSPRs) of
Medical Device Regulation (MDR) 2017/745 that require clinical data per Article 61, GSPRs 1 and 8 as well as
GSPR 2, 4 and 5. The results of the planned clinical evaluation outlined in the CEP document number
0901c76e809e8029 have been documented in this Clinical Evaluation Report (CER) and evaluated against the
state of the art for the intended use of the device under normal conditions of use.
Internal documents used for the preparation of this Clinical Evaluation are listed in Appendix B.
General safety and performance requirements
The following general safety and performance requirements (GSPR) are used for this clinical evaluation.
GSPR 1 (EU MDR Annex I, Req 1): Devices shall achieve the performance intended by their manufacturer and
shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for
their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the
safety of patients, or the safety and health of users or, where applicable, other persons, provided that any
risks which may be associated with their use constitute acceptable risks when weighed against the benefits to
the patient and are compatible with a high level of protection of health and safety, taking into account the
generally acknowledged state of the art.
GSPR 8 (EU MDR Annex I, Req 8): All known and foreseeable risks, and any undesirable side-effects, shall be
minimized and be acceptable when weighed against the evaluated benefits to the patient and/or user arising
from the achieved performance of the device during normal conditions of use.

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In addition, to ensure the completeness of all the activities done during the risk assessment process and the
continually cross refence between the medical benefits of the intended use, the clinical activities and the
conducted risk assessment, the following GSPRs relating to the risk assessment have been added:
GSPR 2 (EU MDR Annex I, Req 2): The requirement in this Annex to reduce risks as far as possible means the
reduction of risks as far as possible without adversely affecting the benefit-risk ratio.
GSPR 4 (EU MDR Annex I, Req 4): Risk control measures adopted by manufacturers for the design and
manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged
state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with
each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate
solutions, manufacturers shall, in the following order of priority:
(a) eliminate or reduce risks as far as possible through safe design and manufacture;
(b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks
that cannot be eliminated; and
(c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training
to users. Manufacturers shall inform users of any residual risks.
GSPR 5 (EU MDR Annex I, Req 5): In eliminating or reducing risks related to use error, the manufacturer shall:
(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in
which the device is intended to be used (design for patient safety), and
(b) give consideration to the technical knowledge, experience, education, training and use environment,
where applicable, and the medical and physical conditions of intended users (design for lay, professional,
disabled or other users). 5.5.2017 L 117/94 Official Journal of the European Union EN
2 Scope of clinical evaluation
Identification of device
This Clinical Evaluation covers the wireless rechargeable hearing aid Oticon More 1 and its accessories.
Proprietary names of the device covered by this Clinical Evaluation is:

• Oticon More 1 miniRITE R
Proprietary names for the accessories to Oticon More 1 miniRITE R

• Oticon Charger
• Oticon Genie 2
Optional wireless accessories

• Oticon ON App

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• Oticon RemoteCare App

• Oticon Remote Control
• Oticon TV Adapter
• Oticon Phone Adapter
• Oticon ConnectClip
• Oticon EduMic
Identification of manufacturer
Legal manufacturer of Oticon’s hearing aids and their accessories:
• SBO Hearing A/S

Kongebakken 9,
DK-2765 Smørum, Denmark
www.oticon.com
• Oticon A/S
Kongebakken 9,
DK-2765 Smørum, Denmark
www.oticon.com
Oticon A/S is the legal manufacturer of the Phone Adapter and the EduMic. For the rest of the
above-mentioned products the legal manufacturer is SBO Hearing A/S.
Device description
2.3.1 Hearing aid
The device under evaluation, Oticon More 1 miniRITE R, is a wireless, rechargeable hearing aid of receiver-in-
the-ear (RITE) style (Figure 1). The RITE style is housed in a case that rests behind the ear. The instrument has
thin electrical wires transmitting the sound to the receiver, or speaker, placed inside the ear canal in an
earbud (dome) or a customized earmold. To cover for a wide range of hearing losses, receivers with different
speaker levels (60/85/100/105) are available. Physical buttons on the back of the device on the shell top
allow the user to e.g. change program and/or volume. The Oticon More 1 miniRITE R is used for impaired
hearing within slight to profound hearing loss. If the hearing disability comprises tinnitus, an optional
feature, Tinnitus SoundSupport, can be activated in the hearing aid (see 2.3.3). More 1 is fitted with the
Genie 2 fitting software.

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Figure 1: Oticon More 1 miniRITE R
Presently, the RITE style is the most common type of hearing aid styles. It is equipped with an external
receiver in the ear canal. The style allows a small housing, which makes it barely visible from the side when
worn. The HCP selects the correct speaker unit, earpieces and ear wax filters for the instruments. An optional
ear grip can be mounted to support the placement.
Figure 2: Position of receiver in ear canal
HI button configuration
The hearing aid is manually controlled using the double push button. A short press turns the volume
up/down (on upper/lower button), if volume control is enabled. A longer press changes programs if several
programs are enabled. A longer press turns the HI off. A very long press switches the HI in flight mode. Flight
mode is disabled by a very long press as well. If off, the hearing aid is manually turned on by pressing the
lower button for two seconds. As an alternative to operating the buttons manually on the hearing aid, it can
be done via the optional Remote Control or the Remote Control app.
Maintenance

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The HI and charger are cleaned with a dry cloth. The HI microphones are cleaned using the brush on the
MultiTool. Custom molds are cleaned, while standard earpieces (domes) are replaced. The wax filters are
replaced.
Service
The battery is replaced by a trained professional (HCP) only. The HCP uses a special tool to open the battery
drawer. The battery is removed and replaced
2.3.2 Mechanical design
Below an overview of the outer mechanical design of the More 1 miniRITE R style.
Figure 3: Overview of the miniRITE R hearing aid
As illustrated in Figure 3, the More 1 miniRITE R is built by more single components. The casing or the shell
contains electro-mechanical parts such as a battery, microphones to capture the sound, a chipset including
an amplifier to process the sound and a receiver part to transmit the processed sound into the ear. For safety

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reasons, a maximum-power output function in the amplifier limits the possible sound pressure from the
hearing aid.
Figure 4: Single components of More 1
Table 2: Parts of the More 1

Pos. Part name
1 Shell, top
2 Push button
3 Rack, left
4 Amplifier (contains microphone)
5 Rack, right
6a Connector for speaker unit
6b Speaker unit with receiver (incl. antenna for 2,4GHz)
7 Shell, basis
8 Battery drawer (for Li-Ion battery)
9 Number plate
10 Service tool

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2.3.3 Principles of operation

The basic principle of operation for an air conducted hearing aid is sound into the hearing aid (input), sound
processed, amplified sound out into the ear canal (output), i.e. a relatively simple, common and stable design
with little evolution.
The wireless More 1 hearing aid consists of the following basic elements (see Figure 5):
a) Microphone
b) Amplifier (sound processing)
c) Speaker (receiver)
d) Power supply (battery)
e) Antenna
f) Sound generator (tinnitus relief sounds)
Microphones and receivers are miniature transducers, meaning they convert energy from one form to
another. The microphone (a) gathers acoustic energy (sound) and converts it into an electrical signal. The
receiver (c) gathers electrical signals from the amplifier (b) and converts them back into acoustic energy
(sound). Located between the microphone and receiver, the amplifier alters the properties of the sound
supplied by the microphone(s) before transmitting it to the receiver, which sends it to the ear canal. The
antenna (d) for the embedded 2.4 GHz radio frequency system is used for wireless connection to external
sources without gateway device. The sound generator (f) is used for generating tinnitus relief sounds as part
of the Tinnitus SoundSupport feature.

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Figure 5 Basic elements of a wireless hearing aid
The basic principle of Tinnitus SoundSupport is to generate audible tinnitus relief sounds and blend these
into the ordinary hearing aid signal.
The optional Tinnitus SoundSupport feature is a software module added to the hearing aid. The Tinnitus
SoundSupport module (the green box at architecture below) is designed to be added to any wireless air
conducted hearing aid the same way and with same connections/controls to the rest of the hearing
instrument, i.e. in the same way across hearing aid generations, product families and brands developed in
Demant HIG.
Figure 6: Tinnitus SoundSupport module
The Tinnitus SoundSupport feature and the hearing instrument itself are designed to be able to
communicate, if the Tinnitus SoundSupport is added as a feature to the instrument. However, as shown in
the architecture of the hearing aid in Figure 6, the Tinnitus SoundSupport is isolated in the design (green box)

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and can be switched on and off. By default, the feature is disabled, and can only be enabled by the HCP in the
fitting software.
2.3.4 Key technical features
The key technical features of More 1 miniRITE R are:

• Bluetooth Low Energy (BLE) antenna for direct streaming, e.g. from smartphones, and Near Field
Magnetic Induction (NFMI) for coordination between left and right hearing aid
• Telecoil (T)
• Rechargeable (R)
• Lithium-ion battery
• LED
• Several speaker units are available for the miniRITE style to cover a range of hearing losses with the
following Max Power Output (MPO; OSPL90, peak) and Full-on Gain (FOG; 1600 Hz),
IEC 60118-0:2015.
MPO FOG
Fitting level 60: 116 dB SPL 37 dB
• 10 kHz bandwidth
• 24 fitting bands
• Compensation of hearing loss: Generic and proprietary fitting rationales are available with a 4/24
hybrid compression system through the MoreSound Amplifiertm.
• Signal improvement: Includes feedback (howl) management (MoreSound Optimizertm), and a
combined adaptive directionality and noise reduction system (MoreSound Intelligencetm) designed to
clean the speech signal from noise via the use of DNN.
• Possibility of more programs and wireless connectivity devices
• Tinnitus SoundSupport (optional)
• Fitting software: Genie 2, version 20.2 and onwards
• Charger
2.3.5 Hearing aid material (biological safety)
Wearing a hearing aid requires skin contact, both in the way it is placed and manually operated.
Behind the ear styles, including the RITE style and hence also More 1 miniRITE R, consist of shell components
moulded of thermoplastic materials which then has been coated with decorative lacquer and a functional
coating. The decorative lacquer used is a multi-layered polyurethane/polyester lacquer and the functional
coating is based upon an acrylate monomer.

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The tubes are typically made of thermoplastic elastomers. For the components going into the end users ears
the soft components are typically made of silicone rubbers and the hard-custom components of a light cured
acrylate.
The product More 1 miniRITE R has been evaluated according to the standard ISO 10993-1:2018 (Biological
Evaluation of Medical Devices) and do not present any biological hazard for the end user and/or the medical
practitioner (Product Biological Evaluation for – More: PBE-2020.01 More).

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Table 3: Materials in contact with body parts

Type: Hearing aid casing [Body contact: Auricle, head when worn. Fingers while operating]
Part/item Classification of Description/Material Type
body contact*
Shell, Top Nature: skin PA12 Glass Fibre Reinforced
Duration: C
(Polyamide 12 with 50% glass fibre)
(EMS-Chemie Grilamid TRVX-50X9)

Shell, Bottom Nature: skin PA12 Glass Fibre Reinforced
Duration: C

Battery Drawer Nature: skin PA12 Glass Fibre Reinforced
Battery Drawer, TAR Duration: C

Functional Coating - shell and battery Nature: skin Perfluoro Polymer Coating
drawer Duration: C (Perfluorodecyl acrylate-based polymer coating)
Lacquer System - shell and battery Nature: skin multi-layered polyurethane/polyester lacquer
drawer Duration: C
Type: Earpieces and Acoustical parts, i.e. receiver/speaker unit [Body contact: Auricle, ear canal when worn. Fingers while
operating]
Part/item Classification of Description/Material Type
body contact*
Stiff rigid components of Nature: skin PA12/PA12 Glass Fibre Reinforced Blend
receivers/speaker units Duration: C
(Blend of Polyamide 12 and Polyamide 12 with 40% glass
fibre)
(Controlled Polymers, Grilamid Blend, 80/20 made of:

80% EMS-Chemie, Grilamid TR55 (781-60-080-00)
20% EMS-Chemie, Grilamid TRV-4X9)
Tubes Nature: skin PA11 (75%)
Duration: C
(Polyamide 11)
(Arkema, Rilsan Besno, BESN O TL)
PEBA (25%)
(Polyether block amide copolymer)
(Arkema, Pebax 7233 SA01, TR)
Ear grips Nature: skin PEBA

Duration: C

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Soft earpieces (domes) Nature: skin Crosslinked Silicone Elastomer

Duration: C
(Whacker Chemie GmbH, elastosil, LR 3003/40)
(Whacker Chemie GmbH, elastosil, R 401/40)
Hard earpieces (custom moulds) Nature: skin Light cured acrylate.

Duration: C
*Categorization by duration of contact, according to ISO 10993-1:

A: Limited exposure (single or multiple use: up to 24h),
B: Prolonged exposure (single multiple or long-term use: more than 24h, less than 30 days)
C: Permanent contact (single, multiple or long-term use: more than 30 days).
2.3.6 Device design history
The device under evaluation, with the purpose of showing MDR compliance, Oticon More 1, is the newest
Oticon product, and is planned to be released to the market in the end of 2020. The release will include three
price points with More 1 being the highest price point. More 1 is a miniRITE R style and hence rechargeable.
The hardware is based on the previous Opn S 1 miniRITE R and has been on the market since February 2019.
No quality complaints regarding the hardware have triggered a change request after the market introduction;
therefore, there are no changes regarding performance and safety of the hardware.
Overview of the Oticon More product family, its price points and year of market introduction.
Price points Styles Speaker levels Year of CE-marking

More 1 miniRITE R 60/85/100/105 December, 2020
More 2
More 3
The optional feature Tinnitus SoundSupport feature, available in More 1, was first introduced to market in
2014 with Oticon Alta 2 Pro TI and has since 2017 been an optional feature in most wireless hearing aids from
Oticon including More 1. No design changes related to this feature has been implemented during these years.
The More 1 hearing aid is developed by Demant HIG and is the latest Oticon hearing aid brought to market,
and as such a result of a 100+ years long history of hearing aid development and sale in Demant HIG.
Demant HIG comprises the Oticon brand as well as the Bernafon, Sonic and Philips brands, and is part of the
Demant Group, where the parent company Demant A/S, earlier known as William Demant Holding A/S,
originally started out as Oticon A/S, was founded in 1904. From 20.2, SBO Hearing A/S will be the legal
manufacturer of all four brands’ hearing aids and their accessories, i.e. for new products, Oticon will
discontinue as legal manufacturer.

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2.3.6.1 Product variants
The device under evaluation, Oticon More 1 miniRITE R, is expected to be placed on the market worldwide in
the end of 2020 as the successor to the Opn S family.
The nature of a RITE style, hence also miniRITE R, is its configurability to different speakers. Oticon More
comprises of four different physical speaker units with different speaker levels
Table 4: More miniRITE R hearing aids, time of CE-marking and introduction to market
Price points Styles Speaker levels Year of CE-marking Markets
More 1 miniRITE R 60/85/100/105 December, 2020 Europe, the
More 2 Americas, Asia
More 3 Africa, Pacific.
Based on the Genie 2 prescription, the HCP selects and mounts the appropriate speaker level for a given
patient. Likewise, the HCP also selects the appropriate earpiece (domes/custom moulds) for the fitting of the
patient.
The different speaker levels cover different degrees of hearing loss. The larger hearing loss, the more
amplification is needed; and the higher the speaker level, the more possible amplification, see below.
60 speaker 85 speaker

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100 speaker 105 speaker
2.3.7 Number of devices on the market
The More 1 miniRITE R device has not yet been released to the market.

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Classification
Hearing aids are intended to be used for the treatment of people suffering from a hearing disability and are
therefore qualified as medical devices.
Hearing aid devices are invasive active therapeutic devices located in the ear canal short term. Hearing aids
are therefore classified as a class IIa device according to Rule 9 (intended to administer or exchange energy)
of the EU MDR 2017/745, Annex VIII.
Device codes
GMDN code and term: 34671
EU MD Code: 1103
EU MDA/MDN: 0310
EU Basic UDI-DI: 57144640-HI-00052-R8
Intended use, indications for use and intended user
Table 5: Fundamentals of use
Hearing instruments (WL-HI) intended for user group: A (children and adults)
Intended use The hearing aid is intended to amplify and transmit sound to the ear.
Bilateral or unilateral impaired hearing of sensorineural, conductive

or mixed type ranging from a slight (16dB HL*) to profound (95dB
Indications for use
HL*) degree of hearing loss, with an individual frequency
configuration.
Person with hearing loss using a hearing aid and their caregivers.
Intended user
Hearing care professional responsible for adjusting the hearing aid
Intended user group Adults and children older than 36 months
Use environment Indoor and outdoor
* As specified by the American Speech-Language-Hearing Association (asha.org), slight hearing impairment is

considered > 16 dB HL and profound hearing impairment is up to 95 dB HL using pure-tone average of 0.5, 1 and 2 kHz.

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The upper limit of the indications for use for More 1 miniRITE R, 95 dB HL, is determined by the output
limitation of the most powerful receiver, speaker level 105.
Tinnitus SoundSupport (optional)
As an optional feature, More 1 offers Tinnitus Sound Support. Tinnitus SoundSupport is a tool intended to
generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus
management program. The target population is the adult population (>18yrs). Tinnitus SoundSupport is
targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists)
who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of Tinnitus
SoundSupport must be done by a hearing care professional participating in a tinnitus management program.
Body parts that interact with the device
Body parts that Auricle and ear canal when placed in the ear. Fingers when operating
interact with device and cleaning the device.
Contraindications and limitations
The identified contraindications and limitations for Oticon wireless hearing aids are all included in the
warnings in the IFU.
Not suitable for infants below 36 months.

Contraindications and
limitations Users of active implants must pay special attention when using the
hearing aid. For more information, read the Warnings section below.
The IFU states the target population as >18 years of age for the Tinnitus SoundSupport feature and there is a
defined limitation on use time when this feature is activated at levels that can potentially be damaging to
residual hearing. These levels and use time limitations are based on the Occupational Safety and Health
administration (OSHA) directive, 2003/10/EC about prolonged noise exposure.
With regards to daily use, the volume level of the Tinnitus SoundSupport sound can potentially be set to a
level which can lead to permanent damage to residual hearing if the device is set up incorrectly by the
hearing care professional or used in an off-label use way by the client. To prevent this, a maximum use time
per day is automatically generated in the fitting software and this information can then be shared with the
client during counselling and in a table in the IFU for the client.
The IFU states the following with regards to limitation on use time of the optional Tinnitus SoundSupport
feature:

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“Daily use: The volume levels of Tinnitus SoundSupport can be set to a level which could lead to permanent
hearing damage when used for a prolonged period of time. Your hearing care professional will advise you of
the maximum amount of time per day you should use Tinnitus SoundSupport. It should never be used at
uncomfortable levels.
See table Tinnitus SoundSupport: Limitation on use, in the Your individual hearing aid settings section at the
end of this booklet to learn how many hours per day you can safely use the relief sound in your hearing aid.”
Side effects
The known possible side effects related to use of hearing aids have been mitigated and are documented in
the IFU under warnings, see 2.9. The identified possible side effects that some users may experience are:
• Hearing aids and earpieces may cause an accelerated accumulation of earwax.

• The non-allergenic materials used in hearing aids may in rare cases lead to a skin irritation or other
side effects.
Please seek consultation with a physician if these conditions occur.
Warnings
The following general warnings are listed in the IFU:
• For your personal safety and to ensure correct usage, you should familiarize yourself fully with the
following general warnings before using your hearing aid.
• Consult your hearing care professional if you experience unexpected operations or serious incidents
with your hearing aid during use or because of its use. Your hearing care professional will support
you with issue handling and, if relevant, reporting to the manufacturer and/or the national
authorities.
• Please note that a hearing aid will not restore normal hearing and will not prevent or improve a
hearing impairment resulting from organic conditions.
• Hearing aid is only a part of hearing habilitation and may need to be supplemented by auditory
training and instruction in lipreading.
• Furthermore, note that in most cases, infrequent use of a hearing aid does not permit a user to
attain full benefit from it.
• This hearing aid is supported by a nonremovable rechargeable lithium-ion battery cell. Please ensure
to charge the hearing aid and familiarize yourself with the safety and handling information related to
rechargeable hearing aids.
• Do not try to get access to the battery inserted in the hearing instrument. The battery must only be
replaced by your hearing care professional. Only charge the hearing aid with a Oticon charger. Other
chargers risk destroying the hearing aid and battery.
• If a battery or hearing aid is swallowed, see a doctor immediately.

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Usage of hearing aids

• Hearing aids should be used only as directed and adjusted by your hearing care professional. Misuse
can result in sudden and permanent hearing loss.
• Never allow others to wear your hearing aid, as incorrect usage could cause permanent damage to
their hearing.
Choking hazards and risk of swallowing small parts

• Hearing aids and their parts should be kept out of reach of children and anyone who might swallow
these items or otherwise cause injury to themselves.
Explosives
• The hearing aid is safe to use under normal usage conditions. The hearing aid has not been tested for
compliance with international standards concerning explosive environments.
• Therefore, do not use the hearing aid in environments with danger of explosions e.g. mines, oxygen
rich environments or areas where flammable anesthetics are handled.
Fatality hazards and risk of swallowing lithium-ion batteries or placing them in the ear or nose
• Never swallow lithium-ion batteries nor place them in the ear or the nose as this may lead to serious
injury or death in as little as 2 hours. This can be due to chemical burn, which can permanently
damage the nose or ear or potentially lead to perforation of the inner organs. If a lithium-ion battery
is swallowed or placed in the ear or nose, seek emergency medical treatment immediately.
Rechargeable battery
• Do not attempt to open the hearing aid, as it may damage the battery.
• Never attempt to replace the battery. If battery replacement is needed, please return your device to
your hearing care professional.
• The service guarantee is void if there are signs of tampering.
• The safety of recharging batteries using a USB connector is determined by the external signal source.
When connected to external equipment plugged into a power socket, this equipment must comply
with IEC-62368-1 or equivalent safety standards.
Dysfunction
• Be aware of the possibility that your hearing aid may stop working without notice. Keep this in mind
when you depend on warning sounds (e.g. when you are in traffic). The hearing aids may stop
functioning, for instance if the batteries have expired or if the tubing is blocked by moisture or ear
wax.
Active implants
• The hearing aid has been thoroughly tested and characterized for human health according to
international standards for human exposure (Specific Absorption Ratio – SAR), induced
electromagnetic power and voltages into the human body.

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• The exposure values are well below internationally accepted safety limits for SAR, induced
electromagnetic power and voltages into the human body defined in the standards for human health
and coexistence with active medical implants such as pacemakers and heart defibrillators.
• If you have an active brain implant, please contact the manufacturer of your implantable device for
information about the risk of interference.
• The Autophone or MultiTool (which has a built-in magnet) should be kept more than 30 centimeters
(1 foot) away from the implant, e.g. do not carry it in a breast pocket.
Detached earpiece in ear canal

• If the earpiece is not on the speaker when removed from the ear, the earpiece may still be in the ear
canal. For further instructions, consult your hearing care professional.
X-ray, CT, MR, PET scanning and electrotherapy and surgery.

• Remove your hearing aid before X-ray, CT/MR/PET scanning electrotherapy, surgery etc. as your
hearing aid may be damaged when exposed to electromagnetic fields.
Heat and chemicals

• The hearing aid must never be exposed to extreme heat e.g. left inside a parked car in the sun.
• The hearing aid must not be dried in microwave ovens or other ovens.
• The chemicals in cosmetics, hairspray, perfume, aftershave lotion, sunscreen lotion and insect
repellent can damage the hearing aid. Always remove your hearing aid before applying such products
and allow time to dry before use.
Power instrument
• Special care should be exercised in selecting, fitting and using a hearing aid where the maximum
sound pressure capability exceeds 132 dB SPL (IEC 60138-4/IEC 711), as there may be risk of
impairing the remaining hearing of the hearing aid user.
For information on whether your hearing aid is a power instrument, see the model overview.
Use on aircrafts
• Your hearing aid contains Bluetooth®. On board an aircraft, the hearing aid must be put into flight
mode to deactivate Bluetooth, unless Bluetooth® is permitted by the flight personnel.
Use of third-party accessories

• Only use accessories, transducers or cables supplied by the manufacturer. Nonoriginal accessories
may result in reduced electromagnetic compatibility (EMC) of your device.
Modification of hearing aids is not allowed

• Changes or modifications not expressly approved by the manufacturer will void the warranty of the
equipment.

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Interference
• The hearing aid has been thoroughly tested for interference according to the most stringent
international standards.
• Electromagnetic interference may occur in the vicinity of equipment with the symbol to the left.
Portable and mobile RF (radio frequency) communications equipment can affect the performance of
your hearing aid. If your hearing aid is affected by electromagnetic interference, move away from the
source to reduce the interference.
Distracted user
• Using your hearing aid can distract you. Be aware of your surroundings while using your hearing aid.
Please refer to national traffic laws regarding the use of communication devices while in traffic.
The following Tinnitus SoundSupport warnings are listed in the IFU for the hearing aid:
• If your hearing care professional has activated the sound generator Tinnitus SoundSupport, ensure
you pay attention to the following warnings.
• There are some potential concerns associated with the use of any sound generated by a tinnitus
management device. Among them are the potential worsening of tinnitus, and/or a possible change
in hearing thresholds.
• Should you experience or notice a change in hearing or tinnitus, or any dizziness, nausea, headaches,
heart palpitations, or possible skin irritation at the point of contact with the device, you should
immediately discontinue use of the device and consult a medical, audiology, or other hearing care
professional.
• As with any device, misuse of the sound generator feature may cause potentially harmful effects.
Care should be taken to prevent unauthorized use and to keep the device out of reach of children
and pets.
Maximum wearing time

• Always follow the maximum wearing time per day of the Tinnitus SoundSupport advised by your
hearing care professional. Prolonged use may lead to worsening of your tinnitus or of your hearing
loss.
2.9.1 Important Notices
The following ‘IMPORTANT NOTICE’ are part of the IFU for More 1 miniRITE R:
• The hearing aid amplification is uniquely adjusted and optimized to your personal hearing
capabilities during the hearing aid fitting performed by your hearing care professional.
• Ensure you always leave the charger connected to a power source when the hearing aid is seated in
the charging port. Turning the charger OFF makes the hearing aid turn ON and start using battery
power.
• The MultiTool has a built-in magnet. Keep the MultiTool at least 30 centimeters (1 foot) from credit
cards and other magnetically sensitive devices.
• To clean the hearing aid, use a soft, dry cloth. The hearing aid must never be washed or immersed in
water or other liquids.

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• If the earpiece is not on the speaker when removed from the ear, the earpiece may still be in the ear
canal. For further instructions, consult your hearing care professional.
• Ensure you always use the same type of wax filter as originally supplied with the hearing aid. If you
are in doubt about the use or replacement of wax filters, contact your hearing care professional.
• Do not use the mute function as an OFF button, as the hearing aid is still using battery power in this
mode
• Do not wear your hearing aid while showering or participating in water activities. Do not immerse
your hearing aid in water or other liquids.
Expected lifespan
The expected lifespan of the hearing aid is 5 years when used and serviced as intended.
Product life-cycle
The lifecycle of the hearing aid is considered from the initiation of the development (at milestone M0 in the
product development process) to the market until product phase out (DOC-0437 SOP – Product Phase Out) is
concluded. The lifespan of the hearing aid is described in 2.3.14
Device claims
The device claims are separated into technical and clinical performance.
Technical performance
Amplification of sound on the patient’s ear is quantified in a range of possible insertion gains that depends
on the chosen fitting level. Inserting gain at 1600 Hz is shown due to the importance of speech at this
frequency.
Fitting level 60: Insertion gain between 0 and 32 dB

Compression of sound at high levels ensure that listening comfort is obtained for speech and environmental
sounds. Compression ratios for loud sounds (between 65 and 80 dB SPL) is between 1:1 and 1:4.
Tinnitus Sound Support (optional)

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The intensity of the tinnitus relief sound on the patient’s ear is quantified in a range of possible levels that is
independent of the chosen fitting level. The maximum sound pressure level is stated in 1/3 octave band
levels.
Fitting level 60: Sound pressure levels in 1/3 octave bands between 0 and 89 dB SPL (shaped for audiogram)
The maximum sound pressure level depends on the spectral shape of the sound. For a more broadband
sound, the maximum sound pressure level would be lower to avoid exceeding the maximum limitation of 90
dB SPL.
Clinical performance
Amplification through individual fitting should ensure audibility of speech. Audibility of speech are quantified
by means of Speech intelligibility index (SII) according to ANSI 3.5 (1997)
The achieved SII benefit (SII aided minus SII unaided) is expected to be larger than 0 %. This is ensured when
the inserting gain is positive across speech important frequencies.
The aided SII (depending on the hearing loss) for normal speech (65 dB SPL) should be within the normative
range using PTA4 (Folkeard et al. 2020).

The individual prescription (starting level) of the tinnitus relief sound fitting should ensure audibility of the
noise. Audibility of tinnitus relief sounds are quantified by the levels of the tinnitus relief sound (dB SPL) in
1/3 octave bands, compared to the hearing threshold level using the same units.
Audibility is ensured once the 1/3 octave band levels exceeds the hearing threshold in dB SPL by 3 dB. This
shall be accomplished for a bandwidth of at least 1/1 octave regardless of the choice of tinnitus sound type.
Safety
MPO measurement shows that the given standards are not exceeded, unless the hearing loss is in the range
of severe-to-profound.
Fitting level 60: MPO does not exceed 132 dB SPL*

Fitting level 85: MPO does not exceed 132 dB SPL*
Fitting level 100: MPO does exceed 132 dB SPL*
Fitting level 105: MPO does exceed 132 dB SPL*
*according to
a) Nordic requirements, Hearing aids – requirements and guidelines. 7th edition. 2007. Vällingby Sweden.

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For people with severe-to-profound hearing losses, the high power setting is necessary in order to compensate for the
hearing loss.
b) IEC 60118-0:2015

The maximum limitation of the tinnitus relief sounds is 90 dB SPL regardless of the choice of tinnitus sound.
Fitting level 60: Maximum overall sound pressure level 90 dB A**

When maximum sound pressure level exceeds 80 dB SPL, a safety advice is shown in the fitting software,
stating the maximum daily wearing time for the specific level according to the following scheme
Overall sound pressure Maximum wearing time

level (dB SPL) (hours)
Less than 80 24
80 19
81 15
82 12
83 9
84 7
85 6
86 4
87 3
88 3
89 2
**according to NIOSH (2020)
2.12.1 Intended clinical benefit to patients
The hearing aid is designed to provide better speech understanding

Clinical benefits
to help ease communication with the aim of improving quality of life.
Tinnitus SoundSupport (optional)

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The intended clinical benefit for patients is, as part of a tinnitus management program run by an HCP, to
provide temporary relief to patients suffering from tinnitus with the aim of improving quality of life.
Accessories
There is an entire system of accessories around the actual device, the wireless hearing aid, More 1. Common
for these accessories is that they do not serve any purpose on their own, nor do they provide any clinical
benefit on their own, which is why they are included in the clinical evaluation of the hearing aid. The fitting
related accessories like the fitting software, Oticon Genie 2, is only used by the HCP, whereas the optional
user need driven accessories, e.g. Oticon Remote Control or the TV adapter are used by the patient and/or
caregiver.
Figure 7. Schematic overview of the hearing aid and its associated accessories
Besides streaming between the hearing aid and its accessories, the wireless technology also allows direct
streaming without gateway to some devices such as e.g. iOS smartphones. A gateway, ConnectClip, is

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necessary when streaming directly from a given listening device is not possible. Table 6 shows the
accessories that can be used with the More 1 device.
Table 6: Overview of the compatible accessories* for More 1

Product Device Class User
Mandatory Oticon Charger Class I HCP, Patient, Caregiver
Oticon Genie 2 Class IIa HCP
Optional Oticon ON App Class IIa Patient, Caregiver
Oticon RemoteCare App Clas IIa Patient, Caregiver
Oticon Remote Control Class I Patient, Caregiver
Oticon TV Adapter Class I Patient, Caregiver
Oticon Phone adapter Class I Patient, Caregiver
Oticon ConnectClip Class I Patient, Caregiver
Oticon EduMic Class I Patient, Caregiver
*For manufacturer, see sec. 2.2.
2.13.1 Fitting software Genie 2
Oticon Genie 2 is the fitting software developed for the Oticon hearing aids. The version currently used for
the More 1 miniRITE model is version 20.2. The fitting software is used to fit the hearing aid to the individual
patient’s needs. As such, the device itself is an accessory to the hearing aid and does not have a stand-alone
function. The IFU of Genie 2 is documented in the file: 219355UK_IFU_Genie_2_2020.2.pdf (2020-07-07) and
can be found in appendix 11.2.5 in this document.
As described earlier, the hearing aids are intended to amplify and transmit sound to the ear and thereby
compensate for impaired hearing. The basic function of hearing aids is that one or more microphones detect
an analogue sound signal in the surroundings. The analogue signal is converted to a digital signal. The digital
signal is amplified and processed according to settings chosen when the device was fitted to the user. The
digital signal is then converted back to an analogue signal and sent to the loudspeaker that plays it into the
ear canal of the user. The individual setting is chosen by the Hearing Care Professional (HCP) who are a
trained person referring to the intended user table above. The settings are done according to diagnostic
measures (such as an audiogram, which is a measure of hearing loss) and the end user needs. The hearing
aids are programmed using the proprietary fitting software, Genie 2.
The Fitting software is classified as a class IIa device according to MDR 2017/745, Annex VIII and
Implementing Rule 3.3 + Rule 9 of the Medical Device Regulation 2017/745 Annex VIII., see appendix 11.2.3.
The Fitting Software is an active therapeutic device intended to administer or exchange energy when it is
connected to a Hearing aid device. Since the fitting software is an accessory to the hearing aids, there are no
therapeutic or clinical claims and no clinical data compiled for the fitting software.
The Genie 2 fitting software installation is provided on a USB drive that contain the installation file. The
Installation program starts automatically when you insert the Genie 2 USB into the port.

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Installation of the software will install Genie 2. If you already have Genie 2 installed, it will automatically be
updated.
Section 3 in the User guide (IFU) do list the system requirements in order to run the fitting software.
The PC must comply with the following requirements:
Hardware
Processor: 2 GHz or faster
RAM: 4 GB or more
Free Hard Disk Space: 8 GB minimum
Graphics: 1280 x 1024 pixels
Ports: USB 2.0 for USB installation and programming devices
Sound: (for SoundStudio) 5.1 surround sound card
SOFTWARE
Operating System: Windows® 10 (32/64 bit), all editions except ARM platform and Windows® 10 S,
Windows® 8 (32/64 bit), all editions except RT, Windows® 7 SP1 (32/64 bit), all editions.
Noah: Noah 4 (minimum), Note: Noah based Office systems must be HIMSA certified.
The fitting software runs on Windows Installer technology and ensures the installing of the intended files and
configuration. In case of problems in the installation, which also are mentioned as a hazard in the risk
assessment, Hazard_496: “The HCP’s attempt to install the fSW fails and the installation is not performed or
not completed. As a result, the fSW will not work” the Windows Installer technology will make a rollback on
the installation and advice the HCP that the installation was unsuccessful.
There is no calibration of the software. In case of later problems on the installation we provide a repair
functionality through Windows Installer technology.
All clinical data related to hearing aids users, including literature search for the hearing devices are compiled
in clinical evaluation reports for the hearing instruments.
Once the product is on the market (post-market), as part of normal lifecycle management processes, we as
manufacturer continue to collect real-world performance data (e.g., complaints, safety data), to further
understand our customer’s needs to ensure the product is meeting those needs, and to monitor the
product’s continued safety, effectiveness and performance in real-world use. This real-world performance
data allows us as the manufacturer to identify and correct any problems, support future expansions in
functionality, meet anticipated user demands, or improve the effectiveness of the device.
For the fitting software, risks have been assessed and mitigated. For all identified risks, an acceptable risk
level is achieved, and necessary warnings are identified. The hazards listed in the risk assessment for fitting
SW do mention, but are not limited to, incorrect use, no access to the IFU and user do not understand the
IFU.

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Several mitigations are in place in order to mitigate incorrect fitting. Each device has a unique Model and
serial number. The fitting SW enables the HCP to verify the Model and serial number of the HA to prevent
the hazard of programming the wrong hearing aid. Also, Clear color coding on receiver units, in product
pictures and receiver selection list box to ensure correct matching with selections in fitting SW and hearing
aids.
The fitting SW will not cause the HA to produce sound levels exceeding prescribed MPO (Client MPO). The
client MPO is limited by Technical MPO. The technical MPO is handled in the Hearing Aid and are mitigated in
“Risk Assessment - Hearing Instruments and Tinnitus Maskers.
In order to ensure that the HCP can locate the IFU. The HCP receive an insert with in the fitting SW packaging
which contain a notification on where to find the electronic version of the IFU and how a paper version can
be obtained.
To mitigate the user do not understand the IFU, the IFU incorporated in the fitting SW describe the fitting
flow with all essential key points so a fitting can be conducted in a safe way. Beside the hard mitigation
mentioned above the fitting SW do also display warnings in the fitting flow for the user to actively close
before continuing the fitting.
The hazards identified in the risk assessment as the potential “worst” hazards are mitigated by warnings in
the fitting flow and require the user to take a stand before proceeding. These hazards are small part warning,
when fitting a child and also the warning related to using a HI than can provide more than 132 dB/SPL will
release a warning in the fitting flow. Furthermore, are these two hazards also identified and handled in the
risk assessment for the HA which are the device that has the clinical performance.
With regards to Tinnitus SoundSupport, an optional hearing aid feature that can be activated and
personalized to the user in the fitting software by the HCP, the following hazards have been identified:
• Unintended use of correct fitting of the Tinnitus SoundSupport

• Reasonably foreseeable misuse
• HCP is not provided sufficient information on intended use, risks related to the fitting level of
Tinnitus SoundSupport (i.e. the tinnitus relief sounds) and the wearing times
• Incorrect use by end-user that exceeds maximum recommended wearing time
• Tinnitus SoundSupport is fitted for an unintended population
• Use of Tinnitus SoundSupport outside of prescribed condition of use.
The hazards relating to Tinnitus SoundSupport exist due to the risk of excessive use of the Tinnitus
SoundSupport, hence when Tinnitus SoundSupport is set to provide levels higher than 80 dB (A) SPL for the
tinnitus relief sound, a warning is provided in the fitting software. The fitting software is also designed to
limit the sound pressure level to 90 dB (A) SPL in order to reduce risk. During the fitting flow the HCP is
informed via the fitting software about the maximum wearing time for the user. The wearing time is also
distributed via a fitting report. Instructions is given to the HCP to enter the users maximum wearing time into
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Tinnitus SoundSupport, Your individual hearing aid settings, More 1 IFU.
Furthermore, warnings (“Tinnitus”) have been implemented in IFU for Genie 2. However, the HCP is a trained
professional and will therefore understand the risk of having a HI than can provide a harmful sound pressure
level. Consequently, the HCP can provide the appropriate counter measures.
Warnings listed in the IFU (UK version) for Genie 2:

Choking hazards
For safety reasons, caution must be taken when fitting children younger than 36 months. Children younger
than 36 months must always use a tamper-resistant battery drawer.
For safety reasons, always use ear moulds when fitting children younger than 36 months.
Power instrument
Special care should be exercised in selecting, fitting and using a hearing aid where maximum sound pressure
capability exceeds 132 dB SPL (IEC 6038-4) as there may be a risk of impairing the remaining hearing of the
hearing instrument user.
Tinnitus
For safety reasons, always caution the user about limiting the use of Tinnitus SoundSupport feature to ensure
safe listening levels.
Be aware of the high sound-pressure level generated by the Tinnitus SoundSupport feature.
Note the recommended limits to the wearing time of the Tinnitus SoundSupport feature as shown in the fitting
software. In the print report and the Instruction for Use for the hearing aid, always enter the maximum wearing
time per day.
Tinnitus SoundSupport is not intended for users below 18 years of age.
Furthermore, these three hazards are also identified and handled in the risk assessment for the HA which are
the device that has the clinical performance.
In addition, the risk assessment has also identified risks related to:

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• Connection
• Firmware
• Real-Ear Measurement system (REM)
• Transfer setting
• In-Situ audiometry
These hazards are identified with a moderate severity. Information to the HCP is given during the fitting flow
and the warnings have also been given in the IFU with the below wording:
Connection
It is important that you do not lose the wired or wireless connection to the hearing instrument or let
communication errors interrupt the fitting flow.
Firmware
During a firmware update, ensure that the user is not wearing the hearing instrument(s) due to the updated
instrument being reset to factory settings after the update. Moreover, do not give the instrument back to the
user before restoring user settings, and ensure that the serial number of the connected instrument
corresponds to the serial number registered in the office automation system for the relevant user. It is also
important that you are aware of the firmware version of the hearing instrument before and after an update,
and that the firmware version of the programming device is compatible with the firmware version of the
fitting software. Avoid interruptions or connection failure to the hearing aid or connectivity device during a
firmware update.
REM System
Pay attention to any error messages from the REM system caused by incorrect or unintended data sent to
the REM system.
Transfer Settings
Ensure that while transferring settings, the user does not wear the hearing instruments.
In-situ Audiometry
Do not use In-situ Audiometry for diagnostic purposes. Also, before you conduct the In-Situ audiometry,
ensure that you add an audiogram in NOAH or in the Client step in Genie 2. Before you conduct In-situ
Audiometry, ensure you remove any REM AutoFit results, and carry out the Audiometry in a quiet area.
All risks listed in the risk assessment for the fitting software have been evaluated considering that the HCP is
a trained professional and will therefore understand the risk of having a HI that can provide a harmful sound
pressure level.

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Conclusion
The overall concepts for fitting software: Fitting of hearing solutions to the needs of the hearing aids users.
The fitting software is an accessory as it is intended to be used together with the hearing aids, i.e. it has no
purpose without a hearing aid. The fitting software is a tool for the HCP, a calculator that based on input
about the hearing aid, the patient’s hearing and listening needs and preferences, programs the hearing aid to
a customized individual setting for the patient.
Consequently, the fitting software does not have its own clinical performance but equals the clinical
performance of the programmed hearing aid leading to the clinical benefit of the hearing aid.
The fitting software’s technical functionality allows it to fulfill its intended use, i.e. to fit and update the
hearing solution and if part of the HCPs clinical practice to facilitate access of real-ear measurement
equipment, i.e. measurement of the hearing aid performance when placed in the ear.
The intended user who is listed in the intended user table of the fitting SW (see below), is a professional with
a relevant and competent education within fitting of hearing aids, and counseling of hearing aid users. The
overall residual risk of the device has been evaluated during risk assessment work mitigated according to
procedure and found acceptable, and the fitting software residual risk is outweighed by the benefit of the
device. The conclusion of this is described in the Risk Management Report.
Sufficient safety information is implemented both in the fitting SW and in the IFU and appropriate methods
for obtaining information from production and post-production are in place.
It is concluded that the IFU do provide the essential information for the HCP in order to start perform a
fitting session taking into account that the HCP of the device is an appropriately trained person and has
proven competency in professionally assessing hearing, selecting, fitting and delivering hearing instrument
systems and rehabilitation care to persons with hearing loss. The IFU explain in steps a straightforward fitting
flow. Furthermore, do the fitting software provide warnings in the fitting flow which need to be considered
before continuing the fitting flow. The intended purpose of the device is described as well as the updated
intended users’ section.
The IFU also refer to the home page: https://www.oticon.com (for professionals) which have information
regarding the fitting software and is publicly available.
Table 7: Overview of key characteristics (fitting software)

Fitting Software – Oticon Genie 2 20.2 or later
Intended use: The fitting software is intended for fitting and updating of
hearing solutions.
The fitting software can facilitate accesses to real-ear
measurement.
Indications for use: No indications for use

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Intended user: The fitting software solution is intended to be used by Hearing

Care Professionals (HCP) who, in this document, are referred to
as, but are not limited to, Hearing Aid Professionals (HAP),
audiologists, ENT (ear, nose and throat) doctors, and Hearing
Aid Dispensers (HAD).
The user of the fitting software shall be a hearing care
professional who is appropriately trained, and has proven
competency in professionally assessing hearing, selecting,
fitting and delivering hearing instruments and rehabilitation
care to persons with hearing loss. The training of the hearing
care professional is in accordance with their specific
educational background following national or regional
regulations.
Use environment: Clinical settings
Contra-indications: No contraindications
Clinical benefits: See clinical benefits of the hearing aid
Medical Class Class IIa
Device Codes GMDN code and term: 60211
EU MD Code: 1111
EU MDA/MDN: 0315
EU Basic UDI-DI: 57144640-fSW-000011-25

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2.13.2 Oticon RemoteCare App (optional)
The remote fitting app, Oticon RemoteCare App, is intended to permit the
fitting of the hearing solution by the HCP remotely. The product is intended
to be used together with the given hearing solution, i.e. including More 1
miniRITE R. The remote fitting app is not intended to be used by anyone <18
years of age.
Oticon RemoteCare feature in Genie 2 enables the HCP to communicate with

their client and to make real-time adjustments to the client’s hearing aids
remotely. The remote fitting app provides a connection between the fitting
software and the client’s hearing aid. If changes cannot be uploaded
remotely, a local visit is necessary.
The Remote Care App is a MDR Class IIa device according to implementing
Rule 3.3 in Annex VIII of the Medical Device Regulation 2017/745 and follows
the main device as accessory to HI: Rule 9 in Annex VIII of the Medical Device
Regulation.
Oticon RemoteCare App is an active therapeutic device intended to

administer or exchange energy when it is connected to a hearing aid device. Since the app is an accessory to
the hearing instrument, there are no therapeutic or clinical claims and no clinical data compiled for the Oticon
RemoteCare App.
For the remote fitting app, risks have been assessed and mitigated. The hazards listed in the risk assessment
for the remote fitting app do mention, but are not limited to, the following areas: erroneous software behavior,
incorrect use, losses of connection, incorrect data transmission and not understanding the IFU.
Several mitigations are in place regarding identified hazards. The remote fitting app does not produce any new
settings by itself- the settings are obtained from fitting software only. All hearing instrument settings are sent
by fitting software in one package and application will apply them to the hearing instrument only if the whole
package has been received. In case of any issues, last correctly saved adjustment will be restored to the hearing
aid and fitting software will be informed, respectively.
The connection line used needs to be encrypted and all losses of connection are covered by appropriate
troubleshooting suggestions for the HCP and the End User. All requirements are listed in the user preparation
checklist and in the app Instructions for use, which the HCP is required to go through with the client during
introduction to the app.
The End User should be informed that prior to Oticon RemoteCare appointment they should ensure that
Bluetooth is on, both hearing aids and mobile phone have sufficient battery level and that Wi-Fi or data used

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the recommended minimum bandwidth of 1/1 Mbit/sec. The HCP is a trained professional which will also have
access to the remote fitting IFU at fitting software level (“Oticon RemoteCare” section in Genie 2 IFU).
For all identified risks, an acceptable risk level is achieved, and necessary information are identified.
Conclusion
The overall concept for Oticon RemoteCare App is remote fitting of hearing aid to the needs of the hearing aid
users.
The overall residual risk of the device has been evaluated, mitigated and found acceptable, and the Oticon
RemoteCare App residual risk is outweighed by the benefit of the device.
Table 8: Overview of key characteristics (remote fitting app)

Remote fitting app - Oticon RemoteCare App (iOS and Android)
Intended use: The remote fitting app is intended to permit the remote fitting
of wireless hearing aids by the hearing care professional. The
app is intended to be used together with the given wireless
hearing aids.
Indications for use: There are no indications for use (diagnoses) for the remote
fitting app itself.
Intended user: Persons with hearing loss using a wireless hearing aid and their
caregivers.
Intended user group Adults above 18 years of age
Use environment: Home setting/Clinical setting
EU MD Code: 1111
EU MDA/MDN: 0315
EU Basic UDI-DI: 57144640-RFITAPP-00056-2Q

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2.13.3 Oticon ON App (optional)
The remote control app, Oticon ON App, is intended

to assist users of wireless hearing aids to control
functionality provided by their hearing solution. The
product is intended to be used together with the
given Oticon hearing solution, i.e. including More 1
miniRITE R.
The Oticon ON App is classified as a class IIa device

according to MDR 2017/745, Annex VIII,
Implementing Rule 3.3 and Classification Rule 9 for
active devices.
The remote control app is an active therapeutic

device intended to administer or exchange energy
when it is connected to a hearing aid device. Since
the app is an accessory to the hearing instrument,
there are no therapeutic or clinical claims, and no
clinical data compiled for the Remote Control App.
For Oticon ON App, risks have been assessed and mitigated. No risks of significantly severity identified. The
Remote Control App is concluded to be safe to use.
Table 9: Overview of key characteristics (remote control app)

Remote Control App - Oticon ON App (iOS and Android)
Intended use: Oticon ON App is intended to assist users of wireless hearing
aids to control functionality provided by their Oticon hearing
solution. The product is intended to be used together with the
given hearing solution.
Indications for use: No indications for use
Intended user: Users of wireless hearing aids. Children below 10 years of age
are expected to be assisted by responsible caregivers.
Use environment: Indoor and outdoor

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EU MD Code: 1111
MDA/MDN: 0315
EU Basic UDI-DI:
iOS: 57144640-RCAPP-00005-A3
Android: 57144640-RCAPP-00006-A6
2.13.4 Oticon Charger
The Oticon Charger is intended to recharge the Oticon

Hearing Aids that contain rechargeable batteries,
including More 1 miniRITE R.
When put in its inductive charger, the Oticon Charger,

the rechargeable More 1 miniRITE R is fully recharged
in max. 3 hours. A fully charged HI allows for an
expected operating time of 24 hours. Hence, the
suggested use pattern is to charge the HI during the
night. A LED on the back of the device shows the
battery status, with green for “fully charged”.
The Charger is classified as a Class I accessory to a medical device (hearing instrument) and will be CE marked
from the 20.2 release. Since the Charger is part of the hearing aid system, there are no therapeutic or clinical
claims and no clinical data compiled for the Charger itself.
For the Charger, risks have been assessed and mitigated. All risks of significant severity has been identified
and mitigated to an acceptable level. The Charger is concluded to be safe to use.
Table 10: Overview of key characteristics (Charger)

Charger - Oticon Charger
Intended use: The charger is intended to recharge the hearing aids that
contain rechargeable batteries.
The product is intended to be used together with the given
hearing solution.
Indications for use: There are no indications for use (diagnoses) for the Charger
itself.
Intended user: Adults and children older than 36 months.
Use environment: Home setting
Clinical benefits: See clinical benefits of the hearing aid.
Medical Class Class I
Device Codes GMDN: 17115

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EU Code: N/A
UDI: 57144640-HICHAR-00048-X6

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2.13.5 Oticon Remote Control (optional)
The Remote Control is intended to assist users of wireless

hearing aids to control functionality provided by their
hearing solution.
The Remote Control controls both the volume and mode of

wireless hearing aids by using radio technology for wireless
transmission, i.e. the Remote Control contains a radio
transceiver using Bluetooth Low Energy (BLE) working at 2.4
GHz frequency.
The Remote Control enables users of wireless Oticon

hearing aids, including More 1 miniRITE R to change the
program or adjust the volume in the hearing instruments.
The Remote Control accessory is a class I device according Rule 13 of the Medical Device Regulation
2017/745, Annex VIII, see appendix 11.2.3. Since the Remote Control is an accessory to the hearing aids, then
there are no therapeutic nor clinical claims and no clinical data compiled for the Remote Control.
For the Remote Control, risks have been assessed and mitigated. No risks of significantly severity identified.
The Remote Control is concluded to be safe to use.
Table 11: Overview of key characteristics (remote control)

Remote Control - Oticon Remote Control 3.0
Intended use: Oticon Remote Control 3.0 is intended to assist Oticon wireless
hearing aids users to control the functionality provided by their
hearing aid.
Indications for use: No indications for use.
Use environment: Indoor / Outdoor.
Contraindications: Users of active implants must pay special attention when using
the device. For more information, read the Warnings section.
EU MD Code: N/A
EU Basic UDI-DI: 57144640-RC-00025-UN

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2.13.6 Oticon TV adapter (optional)
Oticon TV adapter is intended as a wireless

transmitter of sound from a TV or from other
electronic audio devices to Oticon wireless hearing
aids with BLE, including More 1 miniRITE R.
The TV adapter is a sound transmitter using the BLE
(Bluetooth Low Energy) Wireless Technology,
thereby enabling a direct TV listening experience
for the users of hearing aids enabled BLE.
The Oticon TV Adapter contains a radio transceiver

using Bluetooth Low Energy (BLE) and a proprietary
short-range radio technology both working at ISM
band 2.4 GHz.
Oticon TV Adapter is an accessory to a medical device (wireless hearing instrument) with no indications for
use (diagnoses) for the TV Adapter itself, and it is a class I device according to Rule 13 of the Medical Device
Regulation 2017/745, Annex VIII.
Since Oticon TV Adapter is an accessory to the Oticon hearing aids, there are no therapeutic nor clinical
claims, and no clinical data compiled for TV Adapter 3.0.
For the TV Adapter, risks have been assessed and mitigated. No risks of significantly severity identified. The
TV Adapter is concluded to be safe to use.
Table 12: Overview of key characteristics (TV adapter)

TV Adapter – Oticon TV Adapter 3.0
Intended use: TV Adapter 3.0 is intended as a wireless transmitter of sound
from a TV or from other electronic audio devices to Oticon
hearing aids.
Use environment: Home setting.
Contra-indications: No contraindications.
EU MD Code: N/A
EU Basic UDI-DI: 57144640-TVA-00029-VC

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2.13.7 Oticon Phone Adapter 2.0 (optional)
Oticon Phone adapter is intended as an interface

between a conventional landline phone installation
and the Oticon ConnectClip / Oticon Streamer Pro,
in effect turning a pair of Oticon wireless hearing
aids, including More 1 miniRITE R, into a wireless
headset. The Phone Adapter contains a wireless
transmitter using 2.4 GHz technology.
Oticon Phone Adapter is an accessory to a medical device (wireless hearing instrument) with no indications
for use (diagnoses) for the Phone Adapter itself, and it is a class I device according to Rule 13 of the Medical
Device Regulation 2017/745, Annex VIII. Since Oticon Phone Adapter is an accessory to the Oticon hearing
aids, there are no therapeutic nor clinical claims, and no clinical data compiled for Phone Adapter 2.0.
For the Phone Adapter, risks have been assessed and mitigated. No risks of significantly severity identified.
The Phone Adapter is concluded to be safe to use.
Table 13: Overview of key characteristics (Phone adapter)

Phone Adapter – Oticon Phone Adapter 2.0
Intended use: Phone Adapter 2.0 is intended to be used together with Oticon
ConnectClip, Oticon Streamer Pro and Oticon wireless hearing
aids. This enables the hearing aid user to communicate
wirelessly with a phone conversation partner via a landline
phone (analogue/PSTN).
Use environment: Indoor.
Contra-indications: No contraindications.
EU MD Code: N/A
EU Basic UDI-DI: 57071313-PA-00003-KU

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2.13.8 Oticon ConnectClip (optional)

The Oticon ConnectClip is intended as a wireless receiver and
transmitter of sound between hearing aids and the surrounding
environment, including speech and wireless electronic audio devices.
The ConnectClip furthermore assists users of wireless hearing aids to
control the functionality provided by their hearing solution.
The ConnectClip contains a radio transceiver using Bluetooth
technology and a proprietary short-range radio technology all working
at ISM band 2.4 GHz frequency for wireless connections.
The ConnectClip is an intermediate device, which wirelessly connects
Oticon 2.4GHz wireless hearing aids through Bluetooth to most of
mobile phones.
The ConnectClip can be used both as a wireless headset for mobile
phones and as a remote microphone/partner microphone. The
ConnectClip is body worn and can e.g. be clicked on the user’s clothes,
be in a pocket or used around the neck with a lanyard.
The ConnectClip is an accessory to a medical device (wireless hearing instrument) with no indications for use
(diagnoses) for the ConnectClip itself. The Oticon ConnectClip accessory is a class I device according to Rule
13 of the Medical Device Regulation 2017/745, Annex VIII.
Since the Oticon ConnectClip is an accessory to the hearing aids, then there are no therapeutic nor clinical
claims, and no clinical data compiled for the ConnectClip.
For the ConnectClip, risks have been assessed and mitigated. No risks of significantly severity identified. The
ConnectClip is concluded to be safe to use.
Table 14 Overview of key characteristics (ConnectClip)

AudioClip - Oticon ConnectClip
Intended use: ConnectClip is intended as a wireless receiver and transmitter of sound
between Oticon wireless hearing aids and the surrounding
environment, including speech and wireless electronic audio devices.
ConnectClip furthermore assists hearing aids users to control the
functionality provided by their hearing aid.
Use environment: Indoor / Outdoor.
Contra-indications: Users of active implants must pay special attention when using the
device. For more information, read the Warnings section.
EU MD Code: N/A
EU Basic UDI-DI: 57144640-AC-00034-GH

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2.13.9 Oticon EduMic (optional)
The EduMic is intended as a wireless microphone and transmitter of

speech and other audio signals to wireless hearing aids, including
More 1. Normal-hearing or hearing-impaired people can benefit
from using the EduMic together with their hearing instrument, in
order to overcome any negative effects of distance, poor room
acoustics, and/or background noise.
The device contains a radio transceiver using Bluetooth Low Energy
(BLE) and a proprietary short range radio technology both working
at ISM band 2.4 GHz. The EduMic is body worn and can e.g. be
clicked on a speaker’s clothes or used around the neck with a
lanyard.
The Oticon EduMic is an accessory to a medical device (wireless hearing instrument) with no indications for
use (diagnoses) for the EduMic itself, and it is a Class 1 device according to Rule 13 of the Medical Device
Regulation 2017/745, Annex VIII. Since the Oticon EduMic is an accessory to the hearing aids, then there are
no therapeutic nor clinical claims, and no clinical data compiled for the EduMic.
For the Oticon EduMic, risks have been assessed and mitigated. No risks of significantly severity identified.
The EduMic is concluded to be safe to use.
Table 15: Overview of key characteristics (EduMic)
Edumic – Oticon EduMic

Intended use: EduMic is intended as a wireless microphone and transmitter of speech
and other audio signals to the hearing aids.
Use environment: Classroom setting/Personal use.
Contra-indications: Users of active implants must pay special attention when using the
device. For more information, read the Warnings section.
EU MD Code : N/A
EU Basic UDI-DI: 57071313-RMIC-00020-8Z

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Equivalent device
The equivalent device Oticon Opn S 1 is, like Oticon More 1, manufactured by SBO hearing A/S, which
belongs to the Demant A/S Hearing Instrument Group (Demant HIG). As both devices belong to the same
group, Demant HIG, the evaluators have access to the entire technical documentation of Oticon Opn S 1 to
the same extent as to the Oticon More 1 files.
The key technical features of Opn S 1 miniRITE R hearing aid are:

• Bluetooth Low Energy (BLE) antenna for direct streaming, e.g. from smartphones, and Near Field
Magnetic Induction (NFMI) for coordination between left and right hearing aid
• Telecoil (T)
• Rechargeable (R)
• Lithium-ion battery
• LED
• Several units are available for the miniRITE style to cover a range of hearing losses with the
following Max Power Output (MPO; OSPL90, peak) and Full-on Gain (FOG; 1600 Hz), IEC
60118-0:2015.
MPO FOG
• 10 kHz bandwidth
• 16 fitting bands
• Compensation of hearing loss: generic and proprietary fitting rationales are available with a
multichannel compression system (Speech Guard LX).
• Signal improvement: Includes feedback (howl) management (FeedbackShield LX), and a combined
adaptive directionality and noise reduction system designed to clean the speech signal from noise
(OpenSound Navigator)
• Possibility of more programs and wireless connectivity devices
• Compatibility with CROS transmitter
• Tinnitus SoundSupport (optional)
• Fitting software: Genie 2 19.1 and onward
• Charger

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In the equivalence table below, the actual device More 1 is compared to the equivalence device Oticon Opn S 1 with regards to clinical, technical and biological
characteristics.
Table 15. Equivalence table

Actual device Equivalent device
Device
Oticon More 1 Oticon Opn S 1 Analysis and conclusion
Legal manufacturer SBO Hearing A/S
Parent company Demant A/S
Clinical characteristics
Intended use The actual device, More 1, and the equivalent device, Opn S
The hearing aid is intended to amplify and transmit 1, are the same with regards to intended purpose, medical
(Intended purpose) sound to the ear. indication and clinical condition, same target population,
Bilateral or unilateral impaired hearing of sensorineural, application site in the body, and expected clinical benefits.
Indications for use conductive or mixed type ranging from a slight (16dB Consequently, no difference with regards to performance
(Indication and clinical condition) HL*) to profound (95dB HL*) degree of hearing loss, with and safety are expected.
an individual frequency configuration.
Person with hearing loss using a hearing aid and their Conclusion: Same clinical characteristics
caregivers, if applicable.
Intended user
Hearing care professional responsible for adjusting the
hearing aid. References:
User group IU2017-02 Classification - Intended Use - Hearing

Adults and children older than 36 months Instruments and Tinnitus Maskers - Polaris
(Target population)

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Not suitable for infants below 36 months. IU2015-11 Classification - Intended Use - Hearing
Contraindications and limitations Instruments and Tinnitus Maskers - Marvel (17.2, 18.2, 19.1)
Users of active implants must pay special attention when [Opn S]
using the hearing aid.
The wording in the Opn S reference document (and IFU) is
Application site / body part Auricle and ear canal very similar compared to the More document (and IFU). The
small differences are primarily in relation to syntax and
nomenclature together with small content differences
The hearing aid is designed to provide better speech
required for MDR compliance which however does not
Clinical benefits understanding to help ease communication with the aim
impact the clinical characteristics.
of improving quality of life.
Optional hearing aid feature: Tinnitus SoundSupport
Intended use & clinical condition Tinnitus SoundSupport is a tool intended to generate
sounds to provide temporary relief to patients suffering
from tinnitus as part of a tinnitus management program.
Target population
The target population is the adult population (>18yrs).
Adults suffering from Tinnitus and their caretakers
Tinnitus SoundSupport is targeted for licensed hearing

Intended user care professionals (audiologists, hearing aid specialists,
or otolaryngologists) who are familiar with the evaluation
and treatment of tinnitus and hearing losses. The fitting
of Tinnitus SoundSupport must be done by a hearing care

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professional participating in a tinnitus management

program.
The intended clinical benefit for patients is, as part of a

tinnitus management program run by an HCP, to provide
Clinical benefits
temporary relief to patients suffering from tinnitus with
the aim of improving quality of life.
Technical characteristics
Design (hardware) Wireless hearing aid with a BLE antenna for direct Darwin reuses the mechanical and electro-acoustical design
streaming and NFMI for coordination between left and from the Magneto platform but with an update of the
right hearing aid. Both functions are optional. amplifier. This update enables an improved calibration with
the result of better performance in gain.
RITE style with telecoil and four different speaker options
(fitting levels 60, 85, 100 and 105) The miniFit earpieces available for More 1 and Opn S 1 are
the same, with the exception, that for More 1 the open
Tamper resistant battery drawer and a push-button for dome has been replaced by an open bass dome. The open
change of program and/or volume.
bass dome has the benefit of preserving the open sound
Power source is a rechargeable lithium-ion battery size perception for the user additional to better realization of
312 with a visible LED status indicator. gain, especially for the mid frequencies, hence, increasing
the audibility in the frequencies important for speech.
Charger (accessory): Charging time: max 3h. use time:
min 22h.

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Hardware design Darwin Hardware design Magneto In order to prevent adding to the complexity of the dome
selection by adding the new open bass dome, the bass single
dome has been removed from the More 1´s dome portfolio.
The same charger is used for both Opn S 1 and More 1

miniRITE R.
Domes available: Domes available:
Conclusion: Equivalent design
Open Bass Open
Bass double Bass double Reference:

Power Bass single
HW ME and EAD Design Report for Darwin PF1140
Power
HW Platform Design Report Magneto HI ME EAD
Løve, S. (2020) Gain differences between open dome and

open bass dome in Oticon Opn S and Oticon More hearing
aids. Doc No.: 0901c76e809d8208.
Electro-acoustic properties Max Power Output, OSPL90 peak [dB SPL] and The measurements are made according to IEC 60118-0:2015
Electroacoustics - Hearing aids - Part 0: Measurement of the
Full-on Gain [dB], FOG, 1600 Hz. Both in-ear simulator
(IEC-711) performance characteristics of hearing aids.
MPO
Fitting level 60: 116 dB SPL

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Fitting level 105: 135 dB SPL More 1 and Opn S 1 use the same speaker units and
produces the same MPO and very similar FOG.
The hearing aid has built-in technical MPO limitation, Conclusion: equivalent electro-acoustic properties on
Technical MPO. equivalent hardware.
References:
FOG FOG Technical Report More 1 miniRITE R
Fitting level 60: 37 dB SPL Fitting level 60: 37 dB SPL Technical Report Opn S 1 miniRITE R
Fitting level 85: 53dB SPL Fitting level 85: 52dB SPL
Fitting level 100: 60 dB SPL Fitting level 100: 56 dB SPL
Fitting level 105: 66 dB SPL Fitting level 105: 65 dB SPL
Processing platform Polaris Velox S The processing platform named Polaris is used for the More
family whereas Velox S is used for the Opn S family.
Chipset-firmware: Chipset-firmware:
Polaris has more computational power and memory
rel_aurorafw7.6.2 compared to Velox S, and thus enables a more
rel_aurorafw14.31.0
comprehensive processing of sounds, the use of an
Embedded software: increased number of frequency bands together with a more
Embedded software:
rel_2.1_17.0 detailed directionality and noise reduction system utilizing
DNN technology (see below).
rel_5.0_30.1

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10 kHz bandwidth 10 kHz bandwidth The bandwidth is the same for the two platforms, but Polaris
includes 8 additional fitting bands in the frequencies range
24 fitting bands 16 fitting bands of 1-8 kHz, to provide better target match and precision to
which the HA can be tailored to the individual’s preferences.
The differences provide small improvements in audibility but

imply no impact on safety.
Conclusion: Similar audio processing
References:
Technical Report More 1 miniRITE R
Technical Report Opn S 1 miniRITE R
222836UK_TD_Oticon_More_miniRITE_R
205709TR-UK_TD_Opn_S_1-2-3_miniRITE_R_Charger
Hearing loss compensation Gain is prescribed to the individual hearing loss by the The handles and fine-tuning options in the fitting software
fitting SW, for which generic and proprietary fitting are increased for More compared to Opn S due to the
rationales are available with a multi-channel increase in fitting bands.
compression system.
The prescription i.e. calculation of gain and the compression
The fitting SW will not cause the HA to produce sound system has both undergone an update in More 1 to ensure
levels exceeding prescribed MPO (Client MPO). The client continues high performance by utilization of the enhanced
MPO is limited by Technical MPO. frequency resolution for even better target matching
capability.

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Hybrid 4/24 compression 4 channel compression In Opn S 1 the multi-channel compression system comprises
system system of sound processing in 4 channels, whereas More 1, in
addition to the 4 channel system, also includes a sound
processing system with 24 channels (hybrid 4/24
Signal improvement Includes feedback (howl) management, and a combined compression system). This enables the use of an adaptive
adaptive directionality and noise reduction system frequency resolution, i.e. when sound changes quickly the
designed to clean the speech signal from noise. hearing aid uses the 4 channel system, which enables a
quicker processing but when the changes are more slow, the
24 channels system takes over for a more precise
amplification of the 24 frequencies.
The directionality and noise reduction system is in Opn S 1

based on Multi-Channel Enhancement (MCE) algorithm and
labeled as the OpenSound Navigator. In More 1, the MCE
architecture has been extended from 16 to 24 channels,
improved speech and noise detectors have been added and
the noise reduction functionality has been replaced by a
Deep Neural Network (DNN), trained to perform the
function of noise reduction, but in an improved way. The
updated Noise reduction system has been named
“MoreSound Intelligence”. The DNN has been trained with
recordings from real life, which permits a more precise
categorization of the incoming sounds and enables a more
detailed sound processing and prioritization of sound
according to information content. The training of DNN has
however been undertaken and completed in an off-line
system during development and before the HA is released
and as such represents a functionality that is fixed (not

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evolving). The DNN does therefore not change the

fundamentals nor the safety of the HA but is merely an
alternative way of establishing the parameters for noise
reduction to optimize audibility of speech and other sounds
that carry information.
In addition, a slight update in the feedback management

system from Opn S 1 to More 1 has been made to
accommodate a post-marked feedback of unwanted
artifacts.
Conclusion: Equivalent hearing loss compensation
Conclusion: Equivalent signal improvement
References:
222836UK_TD_Oticon_More_miniRITE_R
205709TR-UK_TD_Opn_S_1-2-3_miniRITE_R_Charger
Goodfellow et al, 2016
Tinnitus SoundSupport (optional TSS is a feature in the hearing aid, implemented as a When present in a hearing aid from Demant HIG, including
feature) software module that can be activated by the HCP and More and Opn S, the TSS feature is implemented in the same
used as a tool in a tinnitus management program, i.e. TSS way with the same offering of tinnitus relief sounds.
is one of more offers to the person suffering from
tinnitus. The tinnitus relief sounds which blend with the
ordinary hearing aid sound should be audible for the Conclusion: Same Tinnitus SoundSupport
user. The type and volume of relief sound is selected
according to preference. The volume can be adjusted by

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the user via a volume control but cannot exceed 90 dB References:

SPL.
219448UK_IFU_Oticon_More_miniRITE_R
214211UK_IFU_Opn_S_Opn_Play_Ruby_miniRITE_R
219355UK_IFU_Genie_2_2020.2
214391UK_IFU_Genie_2_2020.1
Charger Oticon Charger The same Magneto charger is used.
(spare part) Conclusion: Same charger
Reference:
223153SG-UK_IFU_Charger_Oticon_miniRITE_R_Multibrand
Fitting software Genie 2 More 1 and Opn S 1 are fitted with Oticon fitting software
Genie 2. More 1 from the 20.2 release, and Opn S 1 from the
(Accessory) 19.1 release.
The 20.2 release includes small updates in relation to user

interface to better support state of the art work paths and to
facilitate the new features in relation to MoreSound
Intelligence.
Conclusion: Equivalent fitting software
References:

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219355UK_IFU_Genie_2_2020.2
196722UK_IFU_Genie_and_Genie2_2019.1
Wireless programmer Noahlink Wireless NoahLink Wireless Noahlink wireless is the programming device used for the
More family. This programming devise is also applicable and
(Accessory, optional) FittingLink already in use for the Opn S family.
Conclusion: Same programmer
References:
219355UK_IFU_Genie_2_2020.2
196722UK_IFU_Genie_and_Genie2_2019.1
Connectivity Oticon ConnectClip Oticon ConnectClip The same wireless accessories for direct streaming are used
(gateway) (gateway) for More and Opn S. The only exception being the Oticon
(Accessories, optional)
Phone Adapter which is not applicable for the Opn S family
Oticon TV Adapter Oticon TV Adapter
but has been applicable to former Oticon product families
Oticon Remote Control Oticon Remote Control and is now being reintroduced to the Oticon More family.
Oticon Cros is not applicable to More 1 in the 20.2 release
Oticon ON App Oticon ON App but is planned to be introduced in the next hardware
release.
Oticon RemoteCare App Oticon CROS

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Oticon EduMic Oticon RemoteCare App Conclusion: Same connectivity
Oticon Phone adapter Oticon EduMic References
219448UK_IFU_Oticon_More_miniRITE_R
214211UK_IFU_Opn_S_Opn_Play_Ruby_miniRITE_R.pdf
Biological characteristics
Magneto materials – Duration of contact with skin of the auricle/head: Prolonged exposure
Shell top and bottom and battery PA12 Glass Fibre Reinforced Same materials are used for the Darwin and Magneto
drawer hardware, and both designs are in contact with the same
(Polyamide 12 with 50% glass fibre) parts of the body.
Conclusion: Same materials in contact with the same body

(EMS-Chemie Grilamid TRVX-50X9) parts
Functional Coating/ Perfluoro Polymer Coating

(Perfluorodecyl acrylate based polymer coating) References:
Hydrophobic Coating BE-2020.01 Darwin miniRITE PF1140 Combined
Product Biological Evaluation for – Opn*: PBE-2016.07
Lacquer System - shell and battery Multi-layered polyurethane/polyester lacquer
drawer *Includes Opn S
Earpieces and acoustical parts – Duration of contact with skin of the auricle/ear canal (*ear canal only): Prolonged exposure
Stiff rigid components of PA12/PA12 Glass Fibre Reinforced Blend

receivers/speaker units

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(Blend of Polyamide 12 and Polyamide 12 with 40% glass Same soft- and hard-piece materials in contact with the
fibre) same parts of the body
(Controlled Polymers, Grilamid Blend, 80/20 made of:
80% EMS-Chemie, Grilamid TR55 (781-60-080-00) Conclusion: Same materials in contact with the same body
parts
20% EMS-Chemie, Grilamid TRV-4X9)
Tubes PA11 (75%)

References:
(Polyamide 11)
BE-2020.01 Darwin miniRITE PF1140 Combined
(Arkema, Rilsan Besno, BESN O TL) Product Biological Evaluation for – Opn*: PBE-2016.07
*Includes Opn S
PEBA (25%)
Ear grip PEBA
Soft earpieces (domes) Crosslinked Silicone Elastomer

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(Whacker Chemie GmbH, elastosil, R 401/40)
Hard earpieces (custom molds) Light cured acrylate.

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Overall conclusion:
Access to the data: As described in the beginning of this section, both devices belong to Demant HIG, thus
data for Opn S 1 is freely accessible for the group of evaluators who are also employees at Demant HIG. The
evaluators involved in the clinical evaluation of More 1 have full access to the technical and clinical
documentation for Opn S 1. Data is accessible through the following internal Demant-HIG databases:
Documentum: documentation for compliance with regulations and standards, product specifications,
validation and verification plans and reports, biocompatibility documentation, clinical evaluation, clinical
investigation.
DOORS: All requirements
Enovia: Product and packaging labels, IFU, PI, TD, UG and SG.
PRADA: Links to all safety/EMC related test reports.
RQM: Test cases, results and defects
Complaint system: a database for complaint handling
Scientific justification of equivalence:
Equivalence of More 1 to Opn S 1 was determined to fulfil the MDR requirement (section 3 of Annex XIV),
that the device to which the manufacturer claims equivalency must share the same technical, biological, and
clinical characteristics, which are further defined in Appendix A1 of MEDDEV 2.7/1 rev 4.
Opn S 1 miniRITE R and More 1 miniRITE R are based on the equivalent hardware design, same
electroacoustic properties and similar audio processing. Both hearing aids are developed and manufactured
according to the same Quality Management System (QMS). Consequently, the characteristics listed in the
table 14 are similar to the extent that there is no clinically significant difference in the safety and clinical
performance of the device (see section 7.1 and 7.2), therefore it can be stated that wireless hearing aid,
Oticon More 1 miniRITE R is equivalent to Oticon Opn S 1 miniRITE R and equivalence justification has been
sufficiently covered through the clinical characteristics described in table 14.
Characteristics Is Opn S 1 equivalent to More 1?

Clinical Yes Same intended use/users
Same indications/contraindications for use
Same expected clinical benefit
Technical Yes Equivalent technical characteristics with similar audio

processing
Biological Yes Same material used
Clinical Evaluation Report for Hearing Aid – Oticon More and Accessories
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3 Clinical background, current knowledge, state of the art

State-of-the art including clinical background, therapeutic management, benefit and risk, literature search
and guidance documents are described in the following for both hearing impairment and tinnitus.
Hearing impairment
3.1.1 Clinical Background
Approximately 466 million people in the world live with a debilitating hearing loss (WHO, 2017). The most
common conditions—age-related and noise-induced sensorineural hearing loss—are both progressive and,
for the near future, neither curable nor reversible. Because persons with hearing loss find it difficult, if not
impossible, to understand what others are saying, especially in noisy environments, people with serious
hearing loss find themselves increasingly isolated from family, friends, and coworkers. Typically, they have
difficulties attending business meetings, enjoying a dinner table conversation, going to the movies, or even
hearing their grandchildren laugh. In addition to the devastating social and psychological isolation, hearing
loss is linked to increased economic hardship, cognitive issues, and other serious problems.
Still today, a typical sensorineural hearing loss cannot be corrected the way, for example, most vision
problems can. However, research shows that wireless hearing aids are efficacious for older adults (Humes et
al., 2017), and in general an increase in satisfaction and substantial benefits in a number of dimensions are
characteristic for the wireless hearing aids brought to market during in the last decade. And this even though
the most advanced digital technology can only compensate and often only partially, for the numerous
complex effects on loudness, frequency response, clarity, and aural resolution that hearing loss creates.
Hearing aid is an aid and not a remedy for curing the hearing loss, and the wish for providing the best
possible help even in complex listening situations has been driving the hearing technology at least for the last
40 years.
Audiologists are the typical healthcare professionals who evaluate, diagnose and treat hearing loss and are
trained to work with all ages, from newborns to the elderly. Some specialize in certain age groups or
conditions as for example pediatric audiologists, who share a common goal of providing infants and children
with hearing loss appropriate access to early intervention like hearing aids. This supports infants and children
with permanent childhood hearing impairment in developing language and literacy skills (Bagatto et al.,
2011).
3.1.1.1 Hearing loss
Hearing impairment is characterized by frequency specific hearing loss, and can occur in one or both ears,
specified as unilateral or bilateral hearing loss. Within the definition of hearing loss types the categories are
sensorineural, conductive and mixed hearing loss.
A sensorineural hearing loss occurs when there is a problem with the sensory (hair cells) and/or neural
structures (nerves) in the inner ear (cochlea). Most often, sensorineural hearing loss involves damage to the
tiny hair cells that are activated by sound waves to vibrate and release chemical messengers that stimulate
the auditory nerve.
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A sensorineural hearing loss not only reduces the intensity of sound but also distorts what is heard—even
when the sounds are loud enough. That is why people with sensorineural hearing loss often struggle to hear
words clearly, particularly certain spoken consonant sounds and when in noisy environments.
Conductive hearing loss is mechanical in nature. That means that something, a physical condition or disease,
is stopping sound from being conducted from the outer or middle ear to the inner ear, where nerves are
stimulated to carry sound to the brain. Often, the cause of conductive hearing loss can be identified and
treated. Medical treatment of conductive hearing loss often allows for partial or complete improvement in
hearing. Then, hearing aids are usually helpful in compensating for any remaining hearing loss.
When someone is professionally diagnosed with hearing loss, typically they’re told how significant the
hearing loss is. The degree of hearing loss can range from “mild” to “profound,” but the question for most
people is, “What does that mean for me?”
Table 16: Degrees of hearing loss (ASHA, 2020) as specified by the American Speech-Language-Hearing
Association (asha.org), using pure-tone average of 0.5, 1 and 2 kHz.
Degree of hearing loss Description
Slight (16-25 dB HL) Slight is a hearing loss category that is typically not treated, unless there is substantial
hearing loss for frequencies above 2000 Hz. As an example, a person may have
substantial hearing loss at high frequencies, which makes it difficult to hear
consonants and may also make it difficult to hear in noise, despite only slight hearing
loss for frequencies from 500 Hz to 2000 Hz.
Mild (26-40 dB HL) People with mild hearing loss usually can hear sounds louder than 26 decibels but
may have some difficulty hearing sounds below 40 decibels.
Here’s how that translates into real life: Soft speech is about 50 decibels. The
humming of a refrigerator is about 40 decibels; a whisper is about 30 decibels;
rustling leaves are about 20 decibels, and the sound of normal breathing is about 10
decibels.
So, someone with mild hearing loss may have minimal or no issues communicating in
quiet, in one-on-one settings, or with only a couple of people. But they tend to have
difficulty hearing softer environmental sounds as well as some conversations,
especially in noisier environments, at a distance, in larger-group settings, or over the
phone.
Moderate (41-55 dB HL) People with moderate hearing loss have trouble hearing sounds below 41 decibels,
but also many sounds in the 41 to 55 decibels range. Sounds in the 41 to 55 decibels
range include those heard in a quiet office, for example. Normal conversational
speech averages between 50 and 65 decibels.
By the time someone has moderate hearing loss, the person often strains to keep up
with conversation in most settings without the use of hearing aids or other assistive
listening devices.
Moderately severe (56-70 People with moderate hearing loss have trouble hearing sounds below 56 decibels,
dB HL) but also many sounds in the 56 to 70 decibels range. Sounds in the 56 to 70 decibels
range include those heard in a somewhat quiet office, for example. Normal
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Degree of hearing loss Description

conversational speech is typically in the range from 50 to 65 decibels. By the time
someone has moderate-severe hearing loss, the person strains to keep up with
conversation in most settings without the use of hearing aids or other assistive
listening devices.
Severe (71-90 dB HL) People with severe hearing loss have difficulty hearing most sounds below 71 decibels
and many between 71 and 90 decibels. Sounds in the 71 to 90 decibels range include
a vacuum cleaner or hair dryer (about 75 decibels) and a garbage disposal (80
decibels).
In day-to-day life, that means that someone with an untreated severe hearing loss
would have severe trouble following most conversations. They likely would have
difficulty even hearing loud speech without amplification, such as hearing aids.
Profound (above 91 dB HL) Someone with profound hearing loss can only hear very loud sounds—those above 91
decibels.
A person with a profound hearing loss probably would not hear any speech and only
very loud sounds. They most often have difficulty hearing and following a
conversation even with hearing aids and often rely on lip-reading and/or sign
language. Individuals with profound hearing loss may benefit from a cochlear implant,
a device that is surgically implanted to substitute for the severely damaged cochlea.
3.1.2 User Groups and treatments options
3.1.2.1 User groups
The Oticon More 1 wireless hearing aids are intended for adults and children aged ≥ 36 months. The device is
contraindicated for infants and children younger than 36 months of age.
The hearing aid itself and its accessories can be handled by patients, caregivers and hearing care
professionals. Only the fitting software Oticon Genie 2 and the wireless programmer are for restricted use by
hearing care professionals.
3.1.2.2 Therapeutic options
Treatments options for patients indicated for the device under evaluation. There is different treatment
options for the three types of hearing loss. From HLAA (2020)
3.1.2.2.1 Conductive hearing loss
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Conductive hearing loss is due to problems with the ear canal, ear drum, or middle ear and its little bones
(the malleus, incus, and stapes).
• Amplification without surgery is the most common solution with a conventional air conduction
hearing aid. In rare cases a solution with a bone-conduction hearing aid can also be an alternative.
• Amplification through surgery may be a solution with the use of an osseointegrated device (bone
anchored device)
• Surgery may correct conductive hearing loss that is due to the congenital absence of ear canal or
failure of the ear canal to be open at birth, congenital absence, malformation, or dysfunction of the
middle ear structures (i.e. from head trauma), and otosclerosis
• Antibiotic or antifungal medications are used to treat chronic ear infections, or chronic middle fluid.
Tumors usually require surgery.
3.1.2.2.2 Sensorineural hearing loss
Sensorineural hearing loss (SNHL) is due to problems of the inner ear, also known as nerve-related hearing
loss.
• Amplification without surgery is the most common treatment option which may be managed by air
conduction hearing aids.
• Amplification through surgery can be an option when conventional hearing aids are not enough,
typically for profound type of hearing loss. Surgically it can then be treated with cochlear implants.
• A subtype of sensorineural hearing loss is the kind that can fluctuate or change rapidly over time.
Such conditions can be managed medically with or without additional help of a hearing aid.
3.1.2.2.3 Mixed hearing loss
The third hearing loss is a mix of the two others that is caused by a combination of conductive damage in the
outer or middle ear and sensorineural damage in the inner ear (cochlea) or auditory nerve.
The common approach is to treat the conductive component first by surgery and then let the conventional
hearing aid treat the sensorineural component. Alternatively, manufacturer of hearing aid, also offers
hearing aid fitting strategies that can compensate for both types of hearing losses.
3.1.2.2.4 Unilateral fitting
Normally, if both ears have less than normal hearing (bilateral hearing loss), the maximum benefit would
likely be attained when using two hearing aids (bilateral hearing aid fitting). Throughout this document,
bilateral hearing loss and the use of two hearing aids is assumed except where noticed. However, less used
than a bilateral hearing aid fitting is the treatment option of fitting only one hearing aid (unilateral hearing
aid fitting). There are two options to consider: unilateral hearing aid fitting for a unilateral hearing loss and a
unilateral hearing aid fitting for a bilateral hearing loss.
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3.1.2.2.5 Unilateral hearing aid fitting for a unilateral hearing loss
Unilateral hearing loss is characterized by hearing reduction in only one ear. There is less problems with a
unilateral hearing loss since there is a normal functioning ear included as well. But there are problems: For
conversations in background noise, individuals with unilateral hearing loss find it more difficulties than their
normal hearing counterparts to understand speech, even when the best ear is positioned towards the source
of speech. Moreover, the spatial location of the sound source is compromised. The perceptual problems can
be minimized with the use of a hearing aid in the impaired ear, which restore some of the perception of
speech and environmental sounds (Dillon, 2012).
3.1.2.2.6 Unilateral hearing aid fitting for a unilateral hearing loss
Among the group of people with a bilateral hearing loss there are some people who only wears one hearing
aid, i.e. have an untreated hearing loss on one ear. The consensus among audiologists is that fitting two
hearing aids offers greater benefit than fitting one only for a bilateral hearing loss. The presumed benefits of
bilateral fitting lie in improved spatial hearing and related forms of binaural processing, and improved
hearing for speech in spatially separated noise (Noble and Gatehouse, 2006). But it is also an experience both
from research and from the field that a substantial proportion of hearing-impaired persons with a bilateral
hearing loss decide that their optimal amplification system includes one hearing aid rather than two. There is
a lack of understanding of the factors leading to non-use of aids. This is true of those who use a single aid as
well as those with two aids (McCormack, 2013).
3.1.3 Hearing aids
For the hearing-impaired user, there are often no alternatives to a hearing device as a therapeutic option,
when the hearing loss is mild to severe. An overview of this option of the current technical and medical state-
of-the-art wireless hearing aid is described in the following. The description is inspired mainly by Kollmeier
and Kissling, 2016 and Hoppe and Hesse (2017).
No matter what style or size, all hearing aids consist of four basic elements (see Figure 8):
a) Microphone
d) Power supply (battery)
e) Antenna
f) Sound generator (tinnitus relief sounds)
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Figure 8: Basic elements of a wireless hearing aid
Microphones and receivers are miniature transducers, meaning they convert energy from one form to
another. The microphone (a) gathers acoustic energy (sound) and converts it into an electrical signal. The
receiver (c) gathers electrical signals from the amplifier (b) and converts them back into acoustic energy
(sound). Located between the microphone and receiver, the amplifier alters the properties of the sound
supplied by the microphone(s) before transmitting it to the receiver, which sends it to the ear canal. The
antenna (e) for the embedded 2.4 GHz radio frequency system is used for wireless connection to external
sources without gateway device. The sound generator (f) is used for generating tinnitus relief sounds as part
of the Tinnitus SoundSupport feature.
The main purpose of the hearing aid can be characterized by five main topics:
1. Compensation for the hearing loss (hearing thresholds)

Hearing thresholds are used to estimate how much amplification is needed to assure audibility. In
principle, this part of the hearing aid should amplify most of the weak sound above the threshold
and at the same time ensure that the sound is not perceived as uncomfortably loud.
2. Compensation for the hearing aid

Placing a hearing aid in the ear or above the ear may introduce some perceptual or acoustical
properties that can interfere negatively with the experience of the hearing aid. Such properties can
be acoustical feedback (howling) due to the closeness of the microphone and receivers, unnatural
perception of own voice due to obstruction of the ear canal, loss of localization due to unnatural
placement of the microphone(s) and the autonomy of left and right hearing aid, Excessive wind noise
due to the turbulence that is created as wind moves past the microphones.
3. Signal improvement (using properties of the sound)

Once amplified, the quality of the sound needs to be as good as possible regarding the most wanted
signal, which is speech. Different methods are used to clean the signal from noise, in the following
called noise reduction.
4. Environment classification and automatics (using properties of the environment)

The degree of noise reduction and other processing schemes require a system that controls when
the different processing schemes are applied most effectively for the user. The control system makes
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use of different properties of the environment as well as assumptions of the most beneficial
processing in a typical environment.
5. Connectivity (using properties of other sound sources)

Wireless HA are capable of wirelessly communicating with external devices as well as with each
other (ear-to-ear communication). Wireless connectivity refers to streaming acoustic or electric
signals from external microphones, telephones, sound systems, and media devices without the use
of hard-wired cables. There are a variety of technologies that make this possible, the most common
of which are electromagnetic fields, frequency modulation (FM) and Bluetooth.
3.1.3.1 Amplification schemes
Amplification is the fundamental concept of hearing aid rehabilitation aiming on the audibility of relevant
sound components, as audibility is a necessary – but not a fully sufficient – requirement for better speech
intelligibility. Linear amplification providing the same amount of gain at all input levels is appropriate for all
hearing impairments not being associated with dynamic range reduction, such as conductive hearing loss.
The majority of hearing aid candidates, however, do have sensorineural impairments with reduced dynamic
range and need non-linear amplification (i.e., compression) to amplify soft sounds with higher gains
compared to loud sounds. Modern non-linear amplification schemes are typically multi-channel wide
dynamic range compression (WDRC) systems to allow frequency-specific restoration of the reduced dynamic
range of the individual hearing aid user. The user benefit of WDRC systems has been thoroughly investigated,
and there is solid evidence these systems improve audibility and leads to an improvement of speech
recognition in soft sound environment compare to the former linear amplification scheme (McCreery et al.,
2012).
3.1.3.2 Noise reduction schemes
When the hearing loss has been (partly) compensated, some hearing aid technologies aims at improving the
signal of interest, i.e., speech. There are two classes of technologies that are designed to reduce unwanted
noise picked up in the environment, also known as improving the signal-to-noise ratio (SNR). A single-
microphone solution makes use of properties of the sound environment. If the spectrum of the background
noise is not identical with the spectrum of the wanted sound, mostly speech, an improvement of the signal-
to-noise ratio (SNR) can be achieved by filtering. For instance, high-pass filtering in situations with traffic
noise with dominant low-frequency properties. Unfortunately, these listening situations are rare.
Particularly, in listening environments, when masking noise happens to be of speech type, simple filtering
does not help to improve speech intelligibility. More efficient than single-microphone solutions are multi-
microphone systems in real listening situations. The concept of SNR improvement by multi-microphone
systems is based on the assumption that noise and speech signals coming from different directions. This
applies for instance in cocktail party situations when the hearing aid users communicate with a single person
or a small group of persons in front of him in a room with surround diffuse speech babble around.
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3.1.3.3 Listening programs
For the optimization of hearing aid parameter settings (gain, frequency response, compression, noise
reduction, directivity, etc.) in different acoustic environments, there are different kind of optional listening
programmes available today. If supplement for the general program is needed, a common approach is to add
special purpose listening programmes, for different acoustic conditions, such as speech in quiet, speech in
noise, music, and telephone. In the most basic version, listening programmes are manually selected by the
user, either using a toggle switch or button on the hearing instrument or a separate remote-control unit.
Some manufacturers offer smartphone apps, both for IOS and Android devices, to enable smartphones being
used as remote-control units.
3.1.3.4 Connectivity
In special listening situations (distant speakers, theatres, cinemas, TV, CD/MP3 players, smartphones, mobile
phones, etc.), an even better SNR improvement can be achieved by direct audio streaming through induction
loops or product-specific wireless systems. On the one hand, inductive solutions are cheaper than wireless
equipment and can be used in a universal, manufacturer-independent way. On the other hand, modern
wireless systems provide more reliability and better sound quality free of artifacts or cross talk effects.
Whereas induction loop system is mostly found in public places (theatres, cinemas) the personal wireless
solutions have been available since the introduction in 2007. There are two types of wireless personal
systems on the market. Some manufactures use Bluetooth or proprietary wireless connection from external
microphones and other external sound sources (via transmitter) to a body-worn streamer at the listener's
end, and the streamer sends the signal to the hearing aids by Near Field Magnetic Induction (NFMI). The
most recent type of wireless products provides direct audio streaming by Bluetooth or other wireless
technology in the GHz range from external sound sources (via transmitter) directly into the hearing aids. This
solution has the advantage that there is no need for an extra streaming device. Some of the solutions still use
a Bluetooth protocol with a fairly high-power consumption which will very soon drain the batteries of those
hearing aids during a couple of hours of TV watching every day. Recently, the major hearing aid
manufacturers have agreed to use a standardized and more power efficient 2.4 GHz wireless (Bluetooth low
energy) protocol to achieve compatibility between wireless accessories (for instance made-for-iPhone) and
hearing aids of all manufacturers.
Beyond streaming features described above, wireless technology has made possible several ear-to-ear
applications. The most basic one is synchronization of volume control and programme use between left and
right hearing instruments. Another ear-to-ear solution makes sure that natural inter-aural level differences
between the ears, used by the brain for localizing sounds, are restored or enhanced if needed. Some models
facilitate telephone calls by streaming the telephone signal to the opposite ear, which is beneficial for many
users, as making phone calls is one of the major problems reported by hearing-impaired persons.
3.1.3.5 Other features
In the class of miscellaneous features, feedback suppression schemes seem to be the most important ones.
Early feedback reduction strategies worked with notch filters or other types of gain reduction to prevent
acoustic feedback. Modern, sophisticated approaches analyze the feedback path and add an antiphase signal
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to the input signal to increase the feedback margin. Sometimes this strategy is combined with a minor
frequency shift between input and output signal to make the system even more stable. Real binaural
feedback suppression schemes can increase feedback margin of up to 20 dB. The efficiency of modern
feedback suppression algorithms has laid the foundation for the success of open fittings in the last couple of
years. Today about 70% of all hearing aid candidates can benefit from open fittings and future technological
progress will increase this proportion.
To circumvent the effect of ‘‘cochlear dead regions’’, frequency lowering schemes have been advocated in
the literature and have been applied in commercial hearing devices without a clear prove of a benefit for
listeners. They employ compensation schemes that aim at spectrally redistributing signal information
avoiding stimulation of such assumed dead regions and/or increasing audibility of high-frequency sounds.
3.1.4 Hearing aid description
With a hearing aid, sounds will be amplified and processed to help compensate for the hearing impairment.
The sound waves in the ear canal will make the ear drum vibrate, causing the mechanical stimulation of the
middle ear and the inner ear from which the electrical stimulation of the hair cells will send the impulse via
the auditory nerve to the brain.
There are several types of hearing aid form factors or styles available on the market, ranging from small
devices in the ear canal only to the behind-the-ear instruments. No matter form factor, all hearing aids are
based on the same fundamental principles and programmed with the fitting software by an HCP to
accommodate for the individual hearing impairment, i.e. the measured audiogram as well as listening
preferences. A hearing aid automatically processes the sound according to level and kind of incoming sound.
If the hearing aid user wants to be able to adjust the sound himself/herself, more programs can be fitted
and/or the volume control can be enabled. The sound can then be changed in specific listening situations by
either pressing the physical button on the hearing aid, using a remote control or a remote control app. In
case of specific needs, e.g. when listening to TV or over the landline phone, accessories like a TV-adapter or
phone adapter may be helpful for the user. Furthermore, in places like e.g. theatres or churches, where an
induction loop is installed, the hearing aid user may benefit from having a telecoil in the hearing aid. Due to
Bluetooth technology, it is also possible to stream sound directly to the wireless hearing aid, e.g. from a
smartphone or other listening devices.
The hearing aid has a battery that either needs to be changed regularly, or if rechargeable to be recharged,
as a rule of thumb, every night. Other aspects of maintenance of the hearing aid include cleaning (custom
mould) or change (dome) of the earpiece.
If needed, i.e. if the hearing or listening demands change over time for a given client, it is possible for the
HCP to adjust or finetune the hearing aid an unlimited amount of times after the initial fitting.
3.1.5 Hearing aid fitting management
For the proper use of hearing aids, hearing aid fitting management (HAFM) is a crucial issue for
manufacturers, dispensers, and service providers, and especially for hearing aid users (Hougaard and Ruf,
2011). Optimal outcomes of hearing aids are supported by comprehensive hearing aid fitting protocols and
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guidelines and the impact of "poor fit and comfort" is particularly notable for hearing aid return rates
(Kochkin, 2007). Accordingly, the whole process of hearing aid fitting needs to be normalized for its efficiency
and transparency, user satisfaction, and cost effectiveness.
The State of the art of HAFM relies on the extraction of components from pre-existing hearing aid fitting
guidelines for both adults and children. This will be shown and discussed in the following, based on the
literature search described in Appendices C and D.
3.1.5.1 HAFM in adults
Hearing aids are one of the most widely-used treatment options for the hearing impaired population (Strom,
2015; Hougaard et al, 2011). The main purpose of this section is to provide an overview of the current state
of the art by comparing and discussing various guidelines and essential components for hearing aid fitting
around the world. The management framework centers on its fitting process with its prior steps of
assessment as well as its posterior steps of follow-up, thereby eliminating diverging interpretations and
nonuniform practices.
The overall methodology, with the time frame of the last 10 years, has been to find as many clinical
guidelines for HAFM as possible. In addition, a literature search has also been conducted to get clinical
guidelines form peer reviewed journals. Guidelines are mainly accessed through different national or
international audiological societies.
The HAFM is defined as a systematic process targeting hearing aid fitting with its prior and posterior stages
to help the hearing impaired recognize and interpret sounds better with hearing aids by providing auditory
training as well as optimizing audibility and comfort. The general framework of HAFM based on the
documentary data of Table 1 with three inclusive aspects: functional, relational, and procedural. The
functional aspect includes the use of hearing aids for helping people with hearing impairments by improving
their hearing ability and overall satisfaction. The relational aspect specifies various relations involving hearing
aids, as depicted in Figure 9, with three modules: 1) assessment, 2) fitting, and 3) follow-up. The procedural
aspect is modeled by a potential flow occurring in the process of HAFM and this model is simply depicted
below: 1) Start at assessment, 2) Go to fitting, 3) Go to follow-up, 4) No further action required if satisfied, 5)
Go to fitting if unsatisfied.
All the guidelines agree on the three modules assessment, fitting and follow-up. However, they differ slightly
with respect to the content of the different modules.
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Figure 9: Procedural aspect is modeled by a potential flow occurring in the process of HAFM
3.1.5.1.1 Assessment
This module encompasses several components including counseling, audiometry testing, hearing aid
selection, and ear impression. The assessment module serves as a framework for investigating the pre-fitting
stage that consists of preparatory components described below. It is generally accepted that counseling
identifies individual needs, concerns, medical history, and abilities and establishes realistic expectations [A1,
A2, A4, A5, A6, A7]. Audiometry primarily evaluates hearing loss of potential hearing aid users by measuring
hearing thresholds and speech recognition scores with various tests such as pure tone audiometry [A1, A2,
A3, A4, A5, A6, A7]. It also includes a thorough otoscopic examination mainly to look for the presence of
cerumen or contra-indications to impression taking and to the fitting of a hearing aid [A1, A3, A4, A5, A7].
Hearing aid selection includes decision making processes associated with hearing aid style, performance
features and anatomic characteristics and cosmetic factors of potential hearing aid users [A1, A2, A3, A5, A6,
A7]. Specifically, it determines earpiece, style, vent, and other physical and acoustical properties of hearing
aids. An ear impression is taken if a customized type of hearing aid is selected, such as shell or behind-the-
ear type [A1, A3, A4, A5, A7]. A customized type of hearing aid, takes several day to produce which means
that the next stage of the HAFM will have to wait until the return of the hearing aid (A1) However, since
taking an ear impression is not necessary for a non-customized type of hearing aid the fitting can proceed
immediately after the assessment appointment.
3.1.5.1.2 Fitting module
The fitting module establishes optimal audibility and physical comfort with hearing aids while ensuring good
sound quality. Ideally, the fitting module efficiently restores hearing loss based on types, degrees, and
configurations of individual hearing by adjusting hearing aids. Then, optimal sound quality and comfort are
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verified with subjective and objective tests. Use and care instructions for hearing aids are also provided at
this module.
The fitting module consisting of three components: 1) adjustment [A1, A2, A3, A4, A5, A6, A7], 2) verification
[A1, A2, A5, A6, A7], and 3) orientation [A1, A2, A5, A7].
Adjustment involves physical and electro-acoustic aspects [A1, A2, A3, A4, A5, A6, A7]. Physical adjustment
aims for maintaining the physical integrity and comfort in wear by modifying and checking physical features
of hearing aids such as modification of earmolds or tubes and evaluation of physical adequacy. Electro-
acoustic adjustment targets optimal establishments of electro-acoustic characteristics of hearing aids based
on types, degrees, and configurations of individual hearing loss. For example, it involves applications of
appropriate fitting formula for prescription of frequency response and compression ratios [A1] as well as of
checking physical and electro-acoustic comfort due to the placement of the hearing aid in or on the ear (e.g.,
acoustic feedback, occlusion) [A1].
Verification is a process evaluating physical, electro-acoustic, and psycho-acoustic aspects with hearing aids
by presenting signals to the hearing aids [A1, A2, A5, A6, A7].
Recommended procedure for verification differs across the different guidelines. There are some that
recommend either real-ear, coupler or behavioral measurements as equivalent [A5] whereas others are in
favor of real-ear measurements only [A1, A2, A6 A7] as long as it is not children and [A1]. Adjustment may be
repeated in case of failed verification.
Orientation, the final component of the fitting module, mainly provides the information relevant to
operational techniques, maintenance strategies including trouble shootings, realistic performance
expectations, and other resources needed for hearing aid users [A1, A2, A5, A7].
3.1.5.1.3 Follow-up
The follow-up module focuses on maximizing and validating hearing aid benefits through auditory training
and outcome measures, respectively. Auditory training attempts to maximize various effects associated with
hearing ability, speech perception, and hearing functions of users. Outcome measures validate acoustic and
psycho-social performances of users after a specified period of time of hearing aid adoption with or without
auditory training. Finally, a comprehensive report for the whole HAFM is necessary for current and future
references.
The follow-up module consisting of three components: 1) auditory training [A1, A2, A3, A4, A5], 2) outcome
measures [A1, A2, A5, A6, A7], and 3) comprehensive report [A1, A2, A5].
Auditory training is an action to aid the capability of hearing perception through hearing aids and to
maximize performance with hearing aids by focusing on various rehabilitative aspects including auditory
perception, communication strategies, and individual needs [A1, A2, A3, A4, A5]. Although entire training
sessions depend on the capability and need of individual hearing aid users, it is generally accepted that
auditory training consists of consecutive training sessions for a certain amount of time.
Outcome measures validate multidimensional aspects of hearing aid usage by measuring the outcomes
associated with acoustic and psycho-social aspects of hearing aid users [A1, A2, A5, A6, A7]. Some common
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outcome domains include measures of speech recognition performance and objective benefits with hearing
aids and subjective measures of sound quality, listening efforts, hearing aid usage, and satisfaction. As shown
previously, if the results from outcome measures with hearing aids are unsatisfactory, the fitting module may
be repeated.
Comprehensive report reflecting substantial information occurred during the whole HAFM process is filed for
informative reports and future references at the final stage of the module [A1, A2, A5]. Additionally, it is
important to note that documentations for each module and component are also needed although this
framework does not specifically address.
3.1.5.2 HAFM in children
Hearing aid fitting for the children population run along the same lines as for adults, see figure 2. In the
following, these state-of-the-art using current protocols and guidelines are presented. Children are defined
as from 36 months of age until 18 years of age.
3.1.5.2.1 Assessment
Normal audiometry using headphones as known from adults is not possible as long as the child is lacking the
attention that is needed in order to assess hearing thresholds behaviorally. As soon as the child is ready for
behaviorally audiometric, they usually start with what is known as play audiometry (Visual Reinforcement
Audiometry), [C1, C2, C3]. One of the biggest challenges at this stage, is to achieve a valid hearing threshold,
since the small size of the baby’s ear complicates the interpretation. There is a need for proper tools to
accomplish this without producing biases [C1, C2, C3].
Counseling: Counseling is I vital part of the hearing aid fitting protocol for children since their language and
educational development depends on a successful hearing aid fitting. For older school children the
counseling a more aligned with adults. At younger ages, however, a detailed counselling of the family is
needed since they are the responsible for the daily management of the hearing aid [C1, C2, C3].
Effective amplification for young children are not possible without the support and understanding of parents.
The audiologist must therefore inform and support parent in a variety of ways. A way to provide ongoing
habilitation is to base the activities around goals determined jointly by the audiologist and the parents (and
by the child when old enough), [C1]
Selection hearing aid: For an infant born with hearing loss, hearing aids should be provided as soon as
possible, no later than at six months of age [C1]. The choice of hearing aid style is often quite limited for
smaller children. A behind the ear hearing aid is the most likely to be provided, in conjunction with soft
earmolds [C1], since this style often has many input sources available (DAI, FM, telecoil, wireless receiver)
and maintenance is easiest for this style. An important safety feature for especially small children are a
tamper resistant battery door as well as a deactivation system for the volume control and other automatic
features [C2].
Ear impression:
Hearing aids are almost always customized for the ear [C1]. There is a need to be an arrangement for taking
impressions for replacement earmolds regularly as long as the physical ear of the child is still developing.
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3.1.5.2.2 Fitting
The choice of the required gain for children compared to adults is still under debate. The weight of evidence
is that children prefer more gain than do adults for normal conversational levels. More important, however,
is to use a validated prescription tool such as DSL version 5 [C2, C3] or NAL-NL2 [C1, C3] in order to calculate
age specific required gain for different input levels.
Verification for children and infant should, as for adults, be based on target matched in real-ears. Again, as
for older children, a real-ear probe assessment is possible in the fitting verification process but since younger
children has difficulties sitting still for more than a few seconds, other methods are used.
A real ear to coupler difference (RECD) is measuring instead using the baby’s own earmold (or a foam insert
earphone tip), [C1, C2, C3]. The advantage of this is, that it is faster to accommodate than a real-ear
verification since the instrument is not present during the measurement. Once RECD is available, the
verification can be completed without the presence of the child but still taking the acoustical uniqueness of
the childs’ ear into account [C1, C2, C3]. As for ear impressions, regularly updates of the RECD is needed due
to changes of the ear, especially during the early years.
In addition to the input levels used for the adults’ verification, the hearing aids saturation is also verified.
High level pure tones (90 dB SPL) is used to provide maximum possible stimulation (unless an alternative
stimulus is recommended by the hearing aid manufacturer). The instrument should be adjusted as necessary
so that the maximum output is below the recommended target for this high level stimuli [C1, C2, C3].
3.1.5.2.3 Follow-up
The follow-up module consisting of the same three components as for adults: 1) auditory training [C1, C2,
C3], 2) outcome measures [C1, C2, C3], and 3) comprehensive report [C1, C2, C3].
Objective measures, such as speech perception tests, are helpful in assessing the child's performance with
the chosen instrument. Subjective questionnaires distributed to teachers and parents can also be used in the
validation process.
The questionnaire that is used for the follow-up process is different than those for the adults. The subjective
outcome evaluation tools that has been validated were the LittlEARS Auditory Questionnaire (parent
questionnaire for children up to 2 years of age) and the Parents’ Evaluation of Aural/Oral Performance of
Children (PEACH) Rating Scale (For both parents of young children as well as school-aged children)
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3.1.6 Hearing Aid Performance and benefit
3.1.6.1 Background
Clinical Benefits: The hearing aid is designed to provide better speech understanding to help ease
communication with the aim of improving quality of life.
There are three performance outcomes with regard to clinical benefit:
1. Improving hearing through audibility

2. Speech intelligibility outcome
3. Subjectively self-reported outcomes
3.1.6.2 Improving hearing through audibility
To understand the clinical benefit of a hearing aid, we need first of all to understand the ability of a hearing
aid to improve hearing. There are three steps in the process of improving hearing.
1. Before a hearing aid or earpiece, is inserted in the ear canal, it has its own unique unaided natural
resonance, that will amplify outer sounds e.g. as much as 15-20 dB in some frequencies before it
reaches the ear drum (REUG in Figure 10).
2. Once the hearing aid or ear piece is inserted into the ear canal, this natural resonance of the ear is
destroyed. Before amplification, it will now make sound less audible compared to without the
hearing aid or earpiece. To make the outer ear as acoustically transparent as before it was inserted,
the aid needs to amplify as much as the ear canal resonance, e.g. 15-20 dB in some frequencies. Now
the aided gain is the same as the unaided gain, and the ear is acoustically transparent. The insertion
gain is through 0 dB.
3. Finally, on top of this, additional gain is added to compensate for the individual hearing loss. This
part of the amplification is the insertion gain and is usually the output format of all fitting
prescriptions. For example, a hearing impaired with a hearing loss of 60 dB HL will need
approximately 30 dB insertion gain in order to make conversational sounds sufficiently audible and
still comfortable.
4. To get an estimate of the overall audibility of speech, the Speech Intelligibility Index, or SII, can be
derived. It is a measure, ranging between 0 and 100% and is highly correlated with the intelligibility
of speech (ANSI S3.5 1997, R2013). The SII can be used to predict speech recognition scores both
with and without a hearing aid, by means of an empirically derived transfer function. These transfer
functions are based on the specific speech materials being used during testing. The actual speech
score depends on the speech material used during testing, as well as the proficiency of the talker and
listener.
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Figure 10: Unaided and aided gain
The difference between the two is the inserting gain,

shown as the shaded region in the top half, and the curve in the lower half (Dillon book “Hearing Aids 2012, page 108)
3.1.6.3 Speech intelligibility outcomes
Measurement of speech intelligibility in quiet and in noise environments
1. In quiet: Speech recognition scores (SRS) is the most common one, which shows how much speech the
patient can understand at a fixed level, typically at a normal conversational level. SRS is measured as
percentages correct words or sentences [%], a higher score indicates better performance.
2. In noise: The signal-to-noise ratio (SNR) at which the patient correctly understands typically 50% of the
spoken material (typically words or sentences). Either the speech or the noise is presented at a fixed
level, and correspondingly the noise or the speech is varying using an adaptive method. The SNR result is
given in dB SNR. A lower value indicates better performance. As an alternative speech recognition scores
(SRS) in noise can be used, that show how much speech the patients can understand at a fixed SNR level,
i.e. both a fixed speech and noise level. SRS in noise is measured as percentages correct words or
sentences [%], a higher score indicates better performance.
There is a range of different standardized speech material both for speech recognition in quiet and in noise
available in different languages. The two most commonly used materials are the HINT and Matrix materials,
these are standardized and available on several languages. Speech intelligibility measures have the strength
compared to sound field hearing thresholds to be more tangible for the users quantifying the benefit with a
hearing device.
3.1.6.4 Subjectively self-reported quality of life
Subjectively self-reported outcomes are also commonly used. These can be divided into:
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1. Hearing‐specific health‐related quality of life measures such as Hearing Handicap Inventory for the
Elderly (HHIE)
2. General health‐related quality of life measures such as Glasgow Benefit Inventory (GBI)
3. Measures of listening ability such as Abbreviated Profile of Hearing Aid Benefit (APHAB), Speech,
Spatial and Qualities of Hearing (SSQ, International Outcome Inventory for Hearing Aids (IOI-HA),
Satisfaction with Amplification in Daily Life (SADL) and Glasgow Hearing Aid Benefit Profile (GHABP).
Satisfaction is the chosen outcome of quality of life in the state-of-the-art both IOI-HA and SADL is
the primary focus.
Tinnitus
3.2.1 Clinical background

Tinnitus can be described as the perception of sound in the absence of external acoustic stimulation. For the
patient it may be trivial, or it may be a debilitating condition (Luxon, 1993). The quality of the perceived
sound can vary enormously from simple sounds such as whistling or humming to complex sounds such as
music-like sounds. The patient may hear a single sound or multiple sounds, in one or both ears, within the
head or outside the body. The symptom may be continuous or intermittent. Tinnitus is described in most
cases as subjective – meaning that it cannot be heard by anyone other than the patient. While, for the
patient, this perception of noise is very real, because there is no corresponding external sound it can be
considered a phantom, or false perception (Phillips and McFerran, 2010).
Globally, 10-15% of adults experience chronic tinnitus, compared to 10% of adults experiencing hearing loss
(Beck,2012). Beck (2012) has suggested using the 80/80 rule to describe the overlap between hearing loss
and tinnitus: 80% of people with hearing loss have tinnitus, and 80% of people with tinnitus have hearing
loss. This significant overlap is one of the main reasons why hearing care professionals are trained in working
with tinnitus. While there is no known cure, there are many treatment options that can be explored so they
can learn to manage their tinnitus in their daily lives.
Historically, tinnitus has been considered a difficult area by doctors, psychologists, audiologists and other
health care professionals simply because tinnitus is a subjective sensation that is difficult to quantify and a
symptom that is difficult and variable to alleviate. The professionals within the field need to understand the
value of giving the patient the best set of tools to manage their tinnitus so that it goes from being a negative
and emotionally charged sound to being a neutral presence that allows the joys of life to continue.
3.2.1.1 Tinnitus severity

When someone is professionally diagnosed with tinnitus, the severity is often assessed. The degree of
tinnitus can be ranged from “slight” to “Catastrophic,” through the standardized tinnitus handicap inventory
severity scale (THI), see Table 17 below. While the contribution of hearing loss to tinnitus severity is unclear
(Baskill & Coles, 1999) there has been reported that higher levels of psychological distress are associated
with more severe or bothersome tinnitus (McCormack et al, 2014).
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Table 17. Degrees of tinnitus severity

Degree of Tinnitus Description
Slight (Score 0-16) Tinnitus is only heard in quiet environment and is very easily masked by
environmental sounds. No interference with sleep or daily activities.
Mild (Score 18-36) Tinnitus is easily masked by environmental sounds and easily forgotten with activities.
May occasionally interfere with sleep but not daily activities.
Moderate (38-56) Tinnitus may be noticed, even in the presence of background or environmental noise,
although daily activities may still be performed.
Severe (58-76) Tinnitus almost always heard, rarely, if ever, masked by environmental noise. Leads to
disturbed sleep pattern and can interfere with ability to carry out normal daily
activities. Quiet activities affected adversely.
Catastrophic (78- 100) Tinnitus always heard and is associated with disturbed sleep patterns, difficulty with
any activity.
(ATA, 2020; McCombre et al. 2001)
3.2.1.2 Tinnitus characteristics

Tinnitus can be any sound but it is typically ringing, buzzing, hissing, or tonal. Some patients experience
multiple sounds. For some the sound is persistent in quality and for others it changes. It can be constant or
intermittent, and heard in one or both ears or inside the head. The sound might be pulsatile (either
synchronous with the heartbeat or not) or non-pulsatile and both types may be objective or subjective.
Tinnitus can in rare cases be objective which means that the perception of the sound has a physical source
generated in or near the ear which can be perceived by an external observer. Subjective tinnitus does not
involve an identifiable sound source so cannot be heard by examination (Cima et al, 2019)
3.2.2 User Groups and treatments options
3.2.2.1 User groups
The Oticon More 1 wireless hearing aid with sound therapy support covered by this Clinical Evaluation
Report is intended for adults (>18 yrs). Children have therefor not been included in this report and are
therefore not covered by the literature review.
3.2.3 Therapeutic options
Tinnitus treatment is typically a combination of several important factors but little knowledge exists on the
effect of such combinations (National Guideline Center, 2020).
There is different treatment options for patients with tinnitus. The following wide range of treatment options
are from the literature search, described in Appendix G (11.8)
Table 18 presents an overview of the six guidelines from the literature search in relation to the six categories
of treatments: Hearing aids, sound therapy, surgery, drugs, psychological therapy and others.
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Table 18: Overview of treatment options for tinnitus

Reference T1 T2 T3 T4 T5 T6
AAO- EU UK Japan Hoare Fuller et
HNS et al. al
Hearing aids x x x x
Sound therapy x x x x x
Surgery x x x
Drugs x x x x x x
Psychological therapy x x x x x
Others x x x x
T1: Tunkel et al. 2014. Clinical practice guideline: Tinnitus

T2: Cima et al. 2019. A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and
treatment
T3: Lewis et al. 2020. Assessment and management of tinnitus: summary of NICE guidance
T4: Ogawa et al. 2020. Clinical practice guidelines for diagnosis and treatment of chronic tinnitus in Japan
T5: Hoare et al. 2011. Systematic Review and Meta-Analyses of Randomized Controlled Trials Examining
Tinnitus Management
T6: Fuller et al. 2017. Different Teams, Same Conclusions? Systematic Review of Existing Clinical Guidelines
for the Assessment and Treatment of Tinnitus in Adults
For an overview of sound therapies is shown in Table 19, with five different options found through literature
review and guideline search since 2010. Following, the options from surgery, Table 20, drugs Table 21
psychological thersapy Table 22 and other options,Table 23.
Table 19: Sound therapy options

HNS et al. al
Tinnitus Retraining
Therapy x x x x x
Tinnitus Masking
therpay x x x
Neuromonics x
Acoustic coordinated
reset neuromodulation x x
Notched music
stimulation x x
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Table 20: Surgery options

HNS et al. al
Surgery for hearing loss x
Cochlear implant x x
Table 21: Drug options

HNS et al. al
Anxiolytics x x x
Antidepressants x x x
Anticonvulsants x x
anti-arrhythmics x
Glutamate receptor
antagonist x
Muscle relaxant x
Benzodiazepines x
Betahistine x
Table 22: Psychological therapy options

HNS et al. al
Cognitive behavioral
therapy (CBT) x x x x x x
Acceptance and
Commitment therapy
(ACT) x x
Mindfulness based x x
Table 23: Other treatment options for tinnitus

HNS et al. al
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Acupuncture x x x x
Repetitive Transcranial
magnetic stimulation x x x x
Vagus nerve
stimulation x
Transcranial electrical
stimulation x x
Physiotherapy x
Seeing as a whole looking at the five main areas of treatments, sound therapy, surgery, drugs, psychological
therapy and others, there is most consensus across guidelines on the use of sound therapy as well as
psychological therapy.
3.2.4 Sound therapy
In order to reduce the perception of tinnitus loudness and the patient’s reactions to tinnitus, sound is used in
different ways. Sound can include something as simple as turning on background music in a quiet room,
turning on a fan, listening to a radio show, or taking a walk on a windy day. If the patient has hearing loss, it
makes sense to expose them to the sound they are missing out on by using hearing aids. This is because the
additional sound can help move mental focus away from the internally created tinnitus sound. Clinically
many patients with tinnitus are unknowingly already using sound therapy in an unintentional way to alleviate
the tinnitus symptoms. The hearing care professional can help them be much more aware of the sounds
around them, learn how to use sound in an effective and systematic way, and how to surround oneself with
pleasant sounds and sounds that carry positive meaning for the individual (Sheldrake and Jastreboff, 2004).
In the following, an outline is presented on the different options that is available for providing sound therapy
that addresses tinnitus.
3.2.4.1 Wearable ear-level devices
Ear-level devices are generally thought of as either a hearing aid alone, a hearing aid plus a sound generator
(combination instrument) or a stand-alone sound generator.
3.2.4.1.1 Hearing aids
As mentioned most tinnitus incidents seem to be accompanied with a hearing loss. Hearing aids have
demonstrated a positive impact on tinnitus even though the aim is to provide the most appropriate
amplification based on a person ’s hearing loss in order to understand speech and other sounds (Shekhawat
et al. 2013). However, the most effective setting of hearing aid for tinnitus relief is still not known but it may
not be the same as the one used for enhancing communication (Shekhawat et al. 2013). Even though hearing
aids are a well-known treatment for patients with both hearing loss and tinnitus, it is still the primary aim to
compensate for the hearing loss.
3.2.4.1.2 Combination instruments
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A hearing aid with a build-in sound generator for tinnitus relief sounds are often referred to as a combination
instrument. Traditionally, combination instruments (and stand-alone sound generators), have focused mainly
on using broadband or narrowband sounds as stimuli, both of which have been widely used in sound
therapy. Tinnitus patients with aidable hearing loss often receive the greatest benefit from combination
Instruments (Henry et al. 2005). The presentation of constant broadband sound to the ears at a controlled
level can be therapeutic, and ear-level devices that contain noise generators are used routinely.
Regardless of how they are used (see below), the ultimate purpose of combination instruments (and sound
generators) is to make the tinnitus less noticeable on a long-term basis.
No matter what style or size, all wireless combination instruments consist of six basic elements, see Figure 11:
a) Microphone(s)
d) Antenna
e) Power supply (battery)
f) Sound generator with relief sounds
Figure 11. Basic elements of a wireless combination instrument
The microphone gathers acoustic energy (sound) and converts it into an electrical signal. The receiver gathers
electrical signals from the amplifier and converts them back into acoustic energy (sound). Located between
the microphone and receiver, the amplifier alters the properties of the sound supplied by the microphone(s)
before transmitting it to the receiver, which sends it to the ear canal. The antenna for the embedded 2,4 GHz
radio frequency system is used for wireless connection to external sources. A sound generator can generate
sound for e.g. tinnitus relief: This sound is also amplified and mixed independently to the hearing aid signal
path.
For the optimization of hearing aid parameter settings (gain, frequency response, compression, noise
reduction, directivity, etc.) as well as tinnitus sound generator settings (type, frequency shape and level of
relief sounds), in different acoustic environments, there are different kind of optional listening programs
available today. If supplement for the general program is needed, a common approach is to add listening
programs, for different special purposes. In the most basic version, listening programs are manually selected
by the user, either using a toggle switch or button on the hearing instrument or a separate remote-control
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unit. Some manufacturers offer smartphone apps, both for IOS and Android devices, to enable smartphones
being used as remote-control units.
3.2.4.2 Relief sound types in combination instruments
Three types of relief sounds are available in combination instruments. These are outlined in
Table 24 below.
Based on Powers et al. (2016), Searchfield et al. (2017), Sweetow and Sabes (2010), and Sereda et al. (2017)
Table 24: Type of sounds

Sound type Examples
Environmental sounds Ocean
Music sounds Fractal sound
Therapeutic noises White, brown, pink, audiogram shaped, notch
shaped, pitch shaped.
As the hearing aid are wireless any sound can be be transmitted through to the hearing aids for those who
would benefit from a wider selection of sounds than the available in the hearing aid itself Piskosz & Dyrlund
(2015)
3.2.4.3 Augmentative Sound
3.2.4.3.1 Portable listening devices
A range of listening device can be used either as a stand-alone or in combination with ear-level devices.
These personal listening devices include wearable radios, CD players, MP3 players, mobile phones,
smartphones and tablets. These various types of devices are all portable listening devices that go where the
person goes. The advantages of personal listening devices are that they can give access almost any sound
imaginable. In recent years, a large number of sound apps has become available on the internet. Sound can
be played or streamed to headphones or combination instruments.
3.2.4.3.2 Tabletop sound generating devices
Tabletop devices offers the same variability of sound choices as the portable listening devices. But in contrast
to portable listening devices, tabletop devices belong in environments where the patient spends his time. For
example, if the patient has any trouble sleeping because of tinnitus, a tabletop sound device could be placed
in the bedroom.
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3.2.5 Tinnitus management
Tinnitus treatment means to give the patient the best set of tools to manage their tinnitus so that it goes
from being a negative and emotionally charged sound to be a neutral presence. The goal of tinnitus
treatment is to help the patient out of the cycle of distress and to reduce their emotional reaction to tinnitus
by accepting the presence of it.
Guidelines for tinnitus management are found through a literature search (in Appendix G), and are all
intended to produce optimal health outcomes for patients, to minimize harms, and to reduce inappropriate
variations in clinical care.
The results of the search was four comprehensive guidelines and six different modules has been identified
and is outlined in Table 25 below.
The schematic flow of the tinnitus management, based on Tunkel et al (2014) and Henry and Manning (2019)
is shown in
Figure 12 below.
The six elements of tinnitus management are described shortly below.
Table 25: The six elements of tinnitus management

Reference Patient history Audiological Tinnitus type Counseling Hearing aid Evidense
and physical examination and severity evaluation based Tinntus
examination treatment
G1 x x x x x x
G2 x x x x x x
G3 x x x x x x
G4 x x x x x
G1: Tunkel et al. 2014. Clinical practice guideline: Tinnitus
G2: Cima et al. 2019. A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and
treatment
G3: Fuller et al. 2017. Different Teams, Same Conclusions? Systematic Review of Existing Clinical Guidelines
for the Assessment and Treatment of Tinnitus in Adults
G4: Henry et al. 2019. Clinical Protocol to Promote Standardization of Basic Tinnitus Services by Audiologists.
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Figure 12: Schematic flow chart of tinnitus management
(Based on Tunkel et al (2014) and Henry and Manning (2019)).
History, examination and assessment (G1, G2 and G3):

The purpose of this module is to emphasize the importance of history and physical examination to identify
potentially treatable causes of tinnitus as well as to identify serious conditions that may cause tinnitus or
accompany tinnitus. An appropriate clinical evaluation should occur early to direct the need for and the type
of additional testing and treatment. Clinicians who evaluate patients with tinnitus should document the
presence or absence of symptoms and conditions that dictate the need for referral to otolaryngology,
audiology, and related specialties. The history should include the details of onset of tinnitus, the duration of
symptoms, and the effects of the tinnitus on patient quality of life. Although most tinnitus patients will have
few relevant positive physical findings, the examination should be directed to identify secondary tinnitus,
with potentially treatable or explainable causes, as well as to find signs of serious disease. associated with
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tinnitus. A routine examination of the head and neck, including careful otoscopy, is the focus of such an
examination. A focused neurologic examination should exclude motor and/or sensory deficits as well as
cranial nerve issues that may accompany central nervous system lesions (G1, G2 and G3).
Audiological assessment:
The purpose of this recommendation is to advise the clinician on situations that warrant prompt audiology
evaluation. Audiologic examination is ideally obtained within 4 weeks of initial patient presentation, as more
urgent audiologic evaluation is rarely needed for tinnitus patients and may not be readily available. Since
tinnitus symptoms of 6 months or longer are less likely to improve spontaneously, audiologic testing is
indicated to identify coexisting hearing loss, to detect hearing loss that may have been unsuspected or
unnoticed by the patient, and to identify unilateral or asymmetric hearing loss that may indicate a more
serious underlying problem. Audiology results can also assist in planning treatment interventions (G1, G2, G3
and G4).
Tinnitus type and severity:

The purpose of this module is to assist clinicians in distinguishing bothersome from nonbothersome tinnitus.
Identification of those with bothersome tinnitus will enable appropriate intervention/management for
patients with bothersome tinnitus and avoid unnecessary intervention/management for those who neither
need nor want it. This guideline defines bothersome tinnitus as that which distresses the patients and affects
their quality of life and/or functional health status. These patients desire management strategies to alleviate
their tinnitus. Nonbothersome tinnitus does not have a significant effect on quality of life but may result in
curiosity or concern about the cause, the natural history of the condition, and treatment options.
Questionnaires can provide an important tool for understanding the problems faced by the patient. A simple
clinical approach is to ask patients to make a list of the problems they attribute to their tinnitus. A number of
tinnitus questionnaires have been developed to determine the level and types of handicaps faced by tinnitus
patients (G1, G2, G3 and G4) (see 3.2.7.1.2 below)
Counseling:
The purpose of this module is to make sure clinicians and patients understand that management strategies
for persistent, bothersome tinnitus do exist. Clinicians should engage the patient or the patient’s proxy in
decision making with awareness of the natural history, the prognosis, and management options. Although
many patients seek help for their tinnitus, they are often told that little or nothing can be done to help them.
Most patients, and many clinicians, do not know the options available for management of tinnitus. They face
tempting advertisements and claims of treatments and cures. Some patients are desperate, and some not
well-informed; often, such patients will seek any kind of treatment offer that has the appearance of
legitimacy. Despite a lack of cure for primary tinnitus, there are many approaches to treatment that can
improve symptoms and relieve distress (G1, G2, G3 and G4).
Hearing aid fitting and evaluation:

The purpose of this module is to recommend a hearing aid evaluation for possible hearing amplification in
patients with bothersome tinnitus and hearing loss. Hearing aids can potentially improve quality of life for
patients and are most likely underutilized because the level of hearing loss and severity of tinnitus may not
be directly correlated. Hearing aids, in general, are underutilized, as 3 of 4 people with hearing loss and 6 of
10 with moderate to severe hearing loss do not use hearing aids (G1, G2, G3 and G4).
Hearing amplification can improve a patient’s quality of life by both treating hearing loss and making the
tinnitus less noticeable. Based on long-term retrospective studies, patients suffering from hearing loss and
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tinnitus receive at least modest benefit from amplification in coping with their tinnitus.
Evidence based tinnitus treatment:

The wide range of treatment options has already been outlined in section 3.2.3 above. Two comprehensive
reviews on tinnitus management and treatment, G1 and G2, also has an evaluation of the effectiveness and
safety profile of some of the most used treatments. Two more specific Cochrane reviews was also included:
Hobson et al (2012) and Fuller et al. (2020). An overview is provided below in Table 26. No doubt, the highest
level of evidence is present for cognitive behavior therapy and only to a lesser degree for the use of sound
therapy. On the other hand, evidence for the safety aspects of sound therapy is fairly high.
Table 26: Overview of the evidence of five of the most common used treatments for tinnitus.
Evidence of performance for Evidence of safety for treatment
treatment
Sound therapy May recommend (G2) Evidence for safety (G2, G7)
Little high level evidence (G7) No side effect has been reported
No strong evidence (Hobson et al, (Hobson et al, 2012)
2012)
Cognitive behavior High level evidence (G2, G7) High level evidence (G2, G7)
therapy May be effective (Fuller et al, Adverse effects may be rare
2020) (Fuller et al, 2020)
Medical therapy Low evidence (G2) Recommendation against (G2,
Recommendation against (G7) G7)
Dietary supplements Low evidence (G2) Evidence for safety (G2)
Recommendation against (G7) Recommendation against (G7)
Acupuncture Little high level evidence (G7) Evidence for safety (G7)
3.2.6 Audiological approaches to sound therapy
Within the treatment of tinnitus there are two levels of management regarding treatment of tinnitus:
1) Reduction of the emotional reaction; which aims to decrease the psychological effects of tinnitus (such as
insomnia, depression and anxiety) and
2) Reduction of the perception, which aims to decrease the tinnitus sensation so that the sufferer will stop
hearing the sounds altogether (Jastreboff et al, 2000). At present there are different management protocols
which show considerable success in achieving the first goal, although no specific therapy for tinnitus is
acknowledged to be satisfactory in all patients regarding the second goal.
There are conflicting accounts for the putative action of many practicable sound therapy options as to
whether they target the tinnitus reaction to promote relaxation and reduce stress or whether they are
actually targeting the tinnitus itself through neuro-plastic change. The correlation between changing reaction
and changing perception, and if achieving the first will lead to the latter is still a subject of discussion.
Targeting the emotional reaction is still the primary goal. Patients may still be aware of their tinnitus, but
they are no longer bothered or distressed by it. Reducing the perception of tinnitus occurs frequently as a
Clinical Evaluation Report for 0901c76e809e80a6 See change 100 of
HI-QMS Hearing Aid – Oticon More log 285
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secondary phenomenon in patients who have achieved sufficiently strong reduction of emotional reaction.
Without prior reduction of emotional reaction in patients with negative connotations towards the tinnitus
however, reduction of perception is unlikely to occur, and symptoms frequently recur (Jastreboff et. al.
2000).
When using sound in reducing emotional reaction to tinnitus there are several ways to set the level or the
characteristics of the relief sound, see Table 27.
Table 27. Principle of setting level of relief sound

Term Principle
Patient preference Tinnitus relief sound level is acceptable,
audible and comfortable
Mixing point A term used to describe the tinnitus relief
sound level where the patient’s tinnitus and
the relief sound are equally audible (Jastreboff
& Hazell, 2004)
Masking The tinnitus relief sound level that completely
masks the patient’s tinnitus
Notch therapy The tinnitus relief sound has a notch around
the spectrum area of the tinnitus sound.
Pitch/ narrow therapy The tinnitus relief sound has a narrowband
spectrum around the same pitch as of the
tinnitus sound.
3.2.6.1 Combined approaches
As mentioned earlier, there are a wide variety of existing approaches to provide tinnitus relief beside the
more audiological ones. Other important factors could include sleep management, relaxation exercises and
sometimes medication for co-existent and exacerbating symptoms such as depression or anxiety (under
management of a medical doctor). Also, when audiological counseling are sometimes not enough more
psychological approaches like cognitive behavior therapy could be used. This represents a dilemma in the
field of tinnitus. First, some patients may be reluctant to see a psychologist, believing that their problems are
to do with the auditory system rather than being psychological in nature. Second, mental health specialists
usually lack expertise in tinnitus rehabilitation. One solution to these problems is for psychological therapies
to be delivered by audiologists rather than mental health specialists. Such an approach has been successfully
tried in recent years (Aazh and Moore, 2018)
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3.2.6.2 Treatment options
3.2.6.3 Unilateral tinnitus: Bilateral treatment
Sometimes tinnitus can be localized only to one side or ear even when hearing loss are either bilateral or
unilateral. In this case sound therapy is still recommended on both ears with combination instruments on
ear(s) with hearing loss or sound generator (Del Bo et al., 2007; Searchfield, 2016). One argument is that this
allows symmetrical stimulation of the auditory system and minimizes the risk that the tinnitus will simply
cross over to the non-symptomatic ear, although there are currently no studies to verify this. It is, however, a
reported finding amongst clinicians with sound therapy experience.
3.2.6.4 Tinnitus and good LF hearing: Open fitting
If a person with tinnitus has good low frequency hearing, it is preferable to keep the ear open to allow direct
access to helpful environmental sounds that can work as sound therapy quite naturally (Del Bo et. Al., 2007;
Searchfield, 2016; Parazzini et al., 2011). An open fitting is here defined as the use of the most open dome
appropriate. It also applies to moulds with large vents.
The ear canal should be left open as much as possible (or venting should be maximal—as appropriate for
slope and degree of loss) to allow normal entry of environmental sound (especially lowest frequency sounds
that are not amplified by the hearing aids) and to reduce the sensation of occlusion. Both of these factors can
contribute to reducing tinnitus perception (Henry et al., 2008). This does not apply to persons with low
frequency hearing loss who need amplification of low-level environmental sounds to benefit from sound
therapy. In these cases, it may be preferable to have a closed fitting that gives more access to these sounds.
A special case of this category of patient are those with near-normal hearing, that is patients on the
borderline between normal hearing and a substantial hearing loss. However, it is difficult to define when a
combination instrument should be prescribed in comparison to only a sound generator. It has been shown
that some patients with a mild hearing loss, not significantly affecting hearing capability can benefit from a
combination instrument as well as a sound generator (Parazzini et al., 2011)
3.2.7 Sound therapy support performance and benefit
3.2.7.1 Background
Clinical Benefit: Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to
patients suffering from tinnitus as part of a tinnitus management program.
There are two performance endpoints with regard to clinical benefit:

1. Audible tinnitus relief sound
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3.2.7.1.1 Audible tinnitus relief sound

To understand the clinical benefit of tinnitus relief sounds, we need first of all to make sure that the tinntus
relief sounds are audible. There are several steps in the process of evaluating audibility of tinnus relief
sounds
1. To evaluate audibility, the threshold of hearing needs to be known. An ear specific audiogram is the
current input to not only the hearing aid fitting but also to the initial setting of the tinnitus relief sounds,
see left side of Figure 13.
Figure 13. Audiogram in dB HL
Hearing thresholds with circles and uncomfortable loudness level in bold line, left side. SPLogram with
audiogram in dB SPL along with prescribed tinnitus relief sound (shaped to audiogram), right side.
2. Since the clinical audiogram is measured in units relative to normal hearing (dB HL) it can also be
expressed in more physical relevant units, dB SPL in the ear canal. This is depicted in the right side of
Figure 13 (with circles).
3. Since tinnitus relief sounds has a broad energy spectrum covering many frequencies there is a need
for assumptions about how the ear is processing such broadbands sounds. One method that is widely
used in the field of audiology (e.g. ANSI, S3.5, 1997) is to assume a hearing resolution equivalent to a
1/3 octave band. Once the energy from the tinnitus relief sounds are analysed in 1/3 octave narrow
bands in dB SPL, they can be compared to hearing thresholds also in dB SPL.
4. This comparison is shown in Figure 13, right side. In this example the tinnitus relief sound (grey
shaded area) are slightly audible (3 dB above threshold) for the frequencies 500 Hz to 6 kHz.
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3.2.7.1.2 Subjectively self-reported outcome

Questionnaires can provide an important tool for understanding the problems faced by the patient. A
number of tinnitus questionnaires have been developed to determine the level and types of handicaps faced
by tinnitus patients, including the Tinnitus Handicap Inventory (THI),(Newman et al. 1996), Tinnitus Reaction
Questionnaire (TRQ),(Wilson et al. 1991), Tinnitus Handicap Questionnaire (THQ), (Kuk et al. 1990) and
Tinnitus Functional Index (TFI),(Meikle et al. 2012).
The questionnaires THI, TRQ and TFI has been chosen as the primary focus in the search for the performance
and safety endpoint.
Identification of pertinent data and appraisal criteria used

The process for data collection, selection and appraisal is described in the CEP and the Data Collection
Reports in Appendices D (actual device), Appendices E (hearing aid technology), Appendix F (HAFM),
Appendix G (Tinnitus management) and H (Safety and Performance endpoints for wireless hearing
aids/hearing impairment), Appendix I (Safety and Performance endpoints combination instrument/Tinnitus).
Applicable standards and guidelines

Guidance documents and their areas of application in the development and evaluation of hearing aids are
listed in Table 28.
Table 28: Applicable standards and guidelines
Document identification Type Full title

REGULATION (EU) 2017/745 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on
medical devices, amending Directive 2001/83/EC, Regulation
2017/745 Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and
repealing Council Directives 90/385/EEC and 93/42/EEC
including: Annex I General Safety and Performance
Requirements
MEDDEV 2.7/1 rev 4 MEDDEV 2.7/1 Clinical evaluation: a guide for
Guidance
(June 2016) manufacturers and notified bodies
EN ISO 14155:2011 Clinical investigation of medical devices
ISO 14155:2011 standard
for human subjects ‒ Good clinical practice
ISO 10993-1:2018 Standard ISO 10993:2018 Biological evaluation of medical devices
EN ISO 13485:2016 Medical devices ‒ Quality management
EN ISO 13485:2016 standard
systems ‒ Requirements for regulatory purposes
EN ISO 14971:2019 Application of risk management to
EN ISO 14971:2019 standard
medical devices
IEC 60118-0:2015 Electroacoustics - Hearing aids - Part 0:
IEC 60118-0:2015 Standard Measurement of the performance characteristics of
hearing aids
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IEC 60318-4:2010 Electroacoustics - Simulators of human

head and ear - Part 4: Occluded-ear simulator for the
IEC 60318-4:2010 Standard
measurement of earphones coupled to the ear by means of
ear inserts.
IEC 62366-1:2015 (Medical devices – Part 1: Application of
IEC 62366-1:2015 Standard
usability engineering to medical devices)
IEC/TR 62366-2:2016 Standard IEC/TIR 62366-2:2016 (Technical report, medical devices –
Part 2: Guidance on the application of usability engineering
to medical devices)
EN 60601-1-6:2010 Standard EN 60601-1-6:2010 (Medical electrical equipment – Part 1-
6: General requirements for basic safety and essential
performance – Collateral standard: Usability)
IEC 62366:2008 Standard IEC 62366:2008 (Medical devices – Application of usability
engineering to medical devices)
IEC 60601-2-66: 2019 Standard EN 60601-2-66:2015 (Medical electrical equipment – Part
2-66: Particular requirements for the basic safety and
essential performance of hearing aids and hearing aid
systems)
HFE/UE Guidance Applying Human Factors and Usability Engineering to
Medical Devices (FDA Guidance February 3, 2016)
State-of-the-art benefit-risk analysis
3.5.1 Hearing impairment
Hearing aids have evolved through four different phases in the history; acoustical, analog, digital and
wireless. The acoustic era (up until 1900) the hearing aids consisted of pre-electric ear trumpets that
captured sound waves, sending them down a tube to the listener’s ear. Later when electricity became
available carbon was used to amplify an electric current to boost the volume of sound. Later, vacuum tubes
were used to control the flow of electricity and, as such, they did make hearing aids a little better. Transistors
enabled hearing aids to fit into a smaller shell. The first transistor hearing aids appeared in 1952, two years
before the first transistor radios. Transistor hearing aids were shrunk over the years, making them small
enough to fit behind the ear and even in the ear. At the end of the analog era, more audiological features
were added to the design. This included output limitation and compression of the sound for better
adaptation to the reduced dynamic range of hearing as well as directional microphones and filtering for a
clearer speech signal. In the late 1980s, several companies were applying digital signal-processing chips to
hearing aids, in hybrid analog-digital models in which digital circuits controlled an analog compression
amplifier. A fully digital model was introduced in 1996, which allowed for greater flexibility and fine-tuning of
the hearing aids according to the patient's needs. By 2005, digital hearing aids had captured more than 80
percent of the market. The digital era also gave new possibilities to hearing aid research and development
and jump-start new areas of hearing aid design. Hearing aid from 2007, although still digital, are wireless. A
wireless radio transmission was introduced linking telephones and other sources together with the hearing
aid. (Dillon book “Hearing Aids” chapter 1.4, page 14 – 19)
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Through all these technological phases of hearing aid development for the past 120 years, the main purpose
of a hearing aid has always been to improve a person’s ability to comprehend speech, even in noisy
environments. As for the early days of hearing aids as well as today, it is important to stress that hearing aid
is an aid and not a remedy for curing the hearing loss. A hearing aid does not normalize the ability to hear.
This applies particularly to sensorineural hearing impairment caused by problems in the inner ear (cochlea),
which is the most common reason for impaired hearing (Dillon book “Hearing Aids” chapter 1.1, page 2).
Only for a very small group of patients with a pure conductive hearing loss (problems in the outer or middle
ear), the hearing aid can almost perfectly compensate for the hearing loss (Dillon book “Hearing Aids”
chapter 1 Synopsis, page 1). But for the majority of hearing impaired who receive hearing aids, it is crucial to
also receive basic counseling on how the aid works and how to use them socially and to provide further
advice and adjustment of their hearing aid if needed (Dillon book “Hearing Aids” chapter 13 Synopsis, page
374). This is important from several standpoints, even to assure that users’ expectations regarding the
benefits of a hearing aid are realistic (Dillon book “Hearing Aids” chapter 9.1.6, page 265-268).
Hearing aids can be beneficial for all degrees of hearing loss. Hearing aids are of greatest benefit for those
with moderate hearing loss. In cases of severe and profound hearing loss, hearing aids are necessary to be
able to comprehend speech since without the hearing aid, speech cues are no longer audible, not even the
loudest speech sounds. Patients with profound hearing loss and poor aided speech comprehension even in
quiet may experience larger benefit from a cochlear implant device that is surgically implanted to substitute
for the severely damaged cochlea (Dillon book “Hearing Aids” chapter 9.2, page 278-280). On the borderline
to normal hearing, the opposite situation exists (Dillon book “Hearing Aids” chapter 9.1, page 258-260). For
mild hearing losses a sufficient amount of the speech is audible, so speech comprehension is possible in
favorable listening situations, even without a hearing aid. However, hearing aids can be beneficial for many
individuals with mild hearing losses and especially in situations where background noise is not excessive
(Dillon book “Hearing Aids” chapter 15.3.1, page 443). Still, for near-normal hearing, there is no precise way
to determine when hearing loss is serious enough so that hearing aids can be of sufficient benefit to motivate
the prescription and use of these devices. Even though that the sound and physical comfort of state-of-the-
art hearing aids are quite high, the decision to use a hearing aid should be made only after the potential user
has had an opportunity to test the device in everyday situations (Dillon book “Hearing Aids”, chapter 9.1.13
last paragraph, page 274).
The use of hearing aids can be accompanied by complications such as inflammation of the ear canal. This
type of inflammation can be caused by poorly fitted inserts, allergic reactions from the plastic components
used in the device or domes, or excessive wax production in the ear. One possible complication concerns the
risk for noise-induced hearing loss if the acoustic output of the hearing aid is too high. There is no evidence
that hearing aids themselves create a risk for further impairing of hearing in users with mild and moderate
hearing loss – provided that appropriate state-of-the-art fitting procedures are followed. In people with
severe-to-profound hearing loss, one cannot exclude the possibility that hearing loss may be exacerbated
(PTS) due to hearing aid amplification even if appropriate routines are followed including prescription of gain
for high input levels and limitation of maximum power output (Dillon book “Hearing Aids”, chapter 10.8,
page 332-334). Fortunately, compared to 30-40 years ago, this situation arises less often now as patients
with this degree of hearing loss are likely to be candidates to cochlear implants.
In addition, recent studies (Johnson, 2017; McCreery et al. 2016) have shown that the established evidence
based prescriptive fitting rationales used in the fitting software further ensure safety in regard to the risk of
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increasing hearing loss through high gain for loud input levels applied by the hearing aid. Both studies
conclude that the output level of the hearing aid for 80 dB SPL input levels prescribed by the fitting rationales
does not exceed the safe output SPL that marks the risk of introducing a permanent threshold shift (PTS).
Also, within the current state-of-the-art era, device features such as wide dynamic range compression and
noise reduction on top of the output limitation, can help decrease gain to lower the risk of further damage of
the ear.
3.5.2 Tinnitus
The concept of the tinnitus relief through the application of external sounds is not new. It is reasonably
certain that Hippocrates in 400 BC was referring to tinnitus masking when he was reported to have said,
“Why is it that the buzzing in the ear ceases if one makes a sound?” In 1883, V. Urbantschitsch (Feldmann
1995) used tuning forks not only to assess the frequency of tinnitus but also to determine their masking
properties.
There are many historical references to masking, but it was not until the experimentation by Spaulding
(1903) that the investigation of the masking principle was organized. He used a piano keyboard in an attempt
to match the perceived pitch of the tinnitus. When the piano note matched the pitch of the tinnitus, the
same note would then be produced on a wind instrument. The intensity of the note would be sustained and
increased until the offending tinnitus was masked. He observed that some patients would experience
complete relief from tinnitus after the external sound was removed (also known as residual inhibition).
Even in view of these early observations about the positive effects of masking, it was not until the work of
Vernon (1975) and DeWeese and Vernon (1975) that a much more formalized approach to tinnitus masking
was formulated. A wearable masker device was developed and used to treat the tinnitus patient (Vernon,
1975). He is to be credited with stimulating and encouraging clinical treatment and research efforts in the
tinnitus arena. With other colleagues (e.g. Vernon et al, 1980; Vernon et al, 1991), he investigated the
utilization and effect of masking in the treatment of the tinnitus patient.
When a masker device is combined in a hearing aid it is referred to as a combination instrument. In the 70s
and 80s combination instruments had limited amplification features relative to full-featured hearing aids.
When hearing is reduced to the point where amplification is indicated, the clinician tries to resolve each of
the needs by providing amplification to improve sound reception and speech awareness and a controlled
masker sound with the purpose to manage tinnitus. Both the masker and hearing aid circuits are contained in
the same housing, making it a rather simple task for the patient or clinician to adjust the level of the hearing
aid, as well as obtain an acceptable level of masker noise. The combination instrument is available in most
form factors. For the last couple of decades, the combination instruments do not sacrifice hearing aid
features, so patients can be fitted with both state-of-the-art sound generators together with state-of-the-art
hearing aids.
Initial approaches to sound therapy involved ’complete masking’ whereby the masking noise is raised in
intensity until the tinnitus becomes inaudible. In the early 1980s a large, complex study of sound therapy
devices included white noise generators and combination hearing aids and noise generators (Hazell 1985).
Further work stemming from this study showed that rather than using a volume of noise that would mask
tinnitus, a low (minimally appreciable) level white noise treatment could be used to achieve downregulation
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(“habituation of the disordered auditory perception”). Subsequent research has refined the instruments and
sought biological evidence for this theory. Low-level noise generators is offered regularly as an element in
many management protocols for tinnitus, rather than ’maskers’ aimed at ’complete or partial masking’ of the
tinnitus in the audiological sense of the word. The effective use of noise generators involves determining the
optimal volume for the device and this will depend on the philosophy behind the management protocol.
Protocols aiming at partial or complete masking aim to establish a masking level that patients find more
acceptable than their tinnitus (Vernon 2003). Often patients are able to achieve effective tinnitus masking at
sound levels that are not very loud, however if the masking needs to be raised to an uncomfortable level to
mask the tinnitus then that patient is not an ideal candidate for masking. If the philosophy is towards sound
therapy and sound enrichment, then the noise generator is adjusted to a level where the patient can hear
both their own tinnitus and the external noise at the same time and the adjustment seeks to establish the
’blending point’.
Despite the lack of systematic reviews and randomized controlled trials demonstrating clear-cut evidence for
sound therapy in alleviating bothersome tinnitus, there is an extensive body of literature describing the
underlying rationale, clinical methodologies, and success rates for different sound therapy approaches (e.g.
Wazen et al. 2011).
On the other hand, Searchfield (2011) has criticised the use of randomized controlled trials often called upon
from systematic reviews, which may be misleading due to the treatment of persons with tinnitus as a
homogenous population, washing out real effects in groups of individuals due to comparison of mean data,
lax inclusion/ exclusion criteria, and non-specific placebo effects. He states, that many of the existing
treatments lacking high evidence to recommend their use, but there is also a lack of evidence to not apply
them; that is, the null hypothesis has not been proven (Searchfield, 2011).
No side effects or morbidity have been reported from the use of any sound therapy intervention (Pichora-
Fuller et al. , 2013; Cima et al., 2019)
Clinical risks associated with the device
Two risks associated with the use of hearing aids have been well-established in the literature: the risk of
damage to the hearing system due to high sound pressure levels and the risk of swallowing the battery pill.
Both risks are addressed in the risk management of the manufacturer and are described in section 4.
Level of evidence to demonstrate conformity with GSPRs
Per MDR Article 61, the manufacturer shall specify and justify the level of clinical evidence necessary to
demonstrate conformity with the relevant general safety and performance requirements. That level of
clinical evidence shall be appropriate in view of the characteristics of the device and its intended use.
The objective of the present clinical evaluation is to conform the clinical performance and safety of the
device, based on the following:
− The technical specifications of the device and verification testing against applicable, international
standards and industry standards.
− Confirmation of the safety of the More 1 in comparison with benchmark devices based on a literature
review of the state of the art.
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− Support of additional claims with sufficient clinical data

− Quantification of benefits in terms of duration and the variation of the level of benefit across the target
population.
The goal of the Clinical Evaluation is to confirm that the device under evaluation:
− performs as intended and specified by the manufacturer,
− has a similar risk profile as comparable devices, and
− is safe to use for both patients and users.
In addition, the goal is to be able to conclude that the device conforms to general safety and performance
requirements (GSPRs) of the MDR, in particular those that require the evaluation of clinical data as per
Article 61 of MDR 2017/745 (GSPR 1 and GSPR 8). The manufacturer must be able to state that the overall
profile of benefits and risks of the device is considered acceptable when used in accordance with its
Instructions for Use (IFU).
To that end, data, as outlined in Section 3.3, will be evaluated for consistency in supporting the requirements
that are also outlined in the same Section. Datasets from multiple sources (PMS, bench-testing, literature)
will be used to support each listed requirement where possible. A justification will be provided for any
requirement in which only one data source is used. In cases where data sources present conflicting
information, a PMCF plan will be created to identify data for verification of the requirement or a plan will be
created to explore documentation revisions that may be needed if requirements cannot be supported.
4 Risk management
Risk analyses of the Oticon hearing aids are performed in accordance with Demant HIG’s procedure – DOC-
0065 SOP – Risk Management. The risk analyses are used to identify potential failure modes (risks) of
wireless hearing aids. In conjunction with conclusions drawn from the evaluation of pertinent technical
characteristics and literature review, the outcomes of these risk analyses are used to demonstrate
compliance with the EN ISO 14971 – Application of Risk Management to Medical Devices. The risk analysis
includes aspects associated with the medical procedure for which the device is intended, technical solutions
adopted, and aspects specific to the design and use of the device.
The manufacturer risk management process has identified clinical risks associated with the device, in an
overall risk evaluation document Risk Assessment - Hearing Instruments and Tinnitus Maskers – Polaris 20.2,
0901c76e8098bbe7, rev. 3.0 then further categorized into user specific risks in and the process/protective
measures in PF1140 Darwin P-FMEA Doc no: 0901c76e8099635b rev. 3.0. The overall risk and residual risk
identified in each document has been reviewed, mitigated as low as possible and deemed acceptable per risk
acceptability criteria identified in DOC 0065. Acceptability rates are confirmed as per review of the State-of-
the-Art section of this document. Consistency and alignment between the clinical evaluation, the labeling
materials, and the risk management documentation for the device under evaluation will be reviewed in this
CER.
The criteria for risk acceptability were determined and documented in the Risk Assessment - Hearing
Instruments and Tinnitus Maskers – Polaris 20.2 and are based on the model as described in the Risk
management Plan - Hearing instruments and Tinnitus Maskers - polaris and Instruction – Risk Activities
during Product Life Cycle (DOC-0592). The manufacturer’s risk management documentation and processes
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will be used as inputs for the clinical evaluation. Typical risks related to the device under evaluation are
related to use errors, biological, and energy hazards, such as, high voltage, low voltage, and thermal hazards.
These risks are inherent to hearing aids and amplification of sound and can be mitigated by conformity to
applicable standards, use of the device limited to the useful lifetime, maintenance and labeling for safety.
DOC-0592 Instruction - Risk Activities during Product Life Cycle
Risks associated with clinical safety of the device will be evaluated by reviewing verifications and validations
that confirm conformity to applicable standards, clinical data from PMS and literature, as well as
manufacturer sponsored clinical investigations. An overview of the relevant clinical risks identified in the
manufacturer’s risk management documentation is provided in section 7.1.
Electrical, thermal, and biological safety of the device under investigation is derived from compliance with
applicable standards (full list of applicable standards in for HI: Regulation and Standard file – HI - Polaris and
for Charger: Regulation and Standard File - Li-ion charger.
In addition, international and industry standards are used to ensure correct performance and safety of the
device. The risk management file will be updated if any information is found during the clinical evaluation
process that reveals previously unforeseen hazards or the need to modify the estimation of the severity or
occurrence of harm. Additional control measures will be determined if necessary.
5 Summary of identified data
Preclinical data
A fundamental requirement with regards to performance of a hearing aid product, including the device
under evaluation, is that the device performs as specified, i.e. in verification and bench-tests of any kinds, it
meets the defined acceptance criteria. As part of preclinical data, the Technical Report for More1 miniRITE R
shall therefore document the electro-acoustic properties of the hearing aid, and the Design Verification of
the hearing aid should show fulfilment of all requirements listed in Checklist for Requirements Review and
Approval for P234, Polaris Oticon . Likewise, for the fitting software, see Checklist for Requirement Review
and Approval for P005 Genie 2 – Release 2020.2.
Verification was done adhering to
• IEC 60118-0:2015 Electroacoustics - Hearing aids - Part 0: Measurement of the performance

characteristics of hearing aids
• IEC 60318-4:2010 Electroacoustics - Simulators of human head and ear - Part 4: Occluded-ear
simulator for the measurement of earphones coupled to the ear by means of ear inserts.
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Clinical data of hearing device
5.2.1 Equivalent device
Two studies on Oticon Opn S 1 have been identified and included in this clinical evaluation. Below is a
summary of own clinical data for the equivalent device, Oticon Opn S 1. Two types of data are available.
Validation data (V),Table 29 and Usability data (U), Table 30.
Table 29: Clinical data from Opn S 1: Validation

Study V1
Caron, A-M; Mathiesen, E; Gusatovic, D. (2019), Validation Results Report Oticon Opn S 1 BTE PP/miniRITE R,
P232
1) Objective The purpose was to validate the user requirements regarding the performance
(effectiveness) of the final Opn S product
2) Design Cross over design (unbalanced) with test HA (Oticon Opn S 1) vs reference HA (Oticon
Opn 1) in a two weeks field trial. There is two different styles and fitting level enrolled in
the trial: Opn S 1 BTE PP miniRITE R.
3) Population 24 adults with hearing impairment average age of 73 y (49-86y)
4) Performance There were found significantly differences in favor of Opn S 1 compared to Opn 1 both in
terms of speech intelligibility (p<0,0001) and sound quality (p<0,001). Overall 96%
preferred Opn S 1 (23 of 24 TPs) while only one TP preferred own Opn 1. The most
important reasons for preference were better Speech Intelligibility and Sound Quality,
just as rechargeability was an important reason for preference for the 12 TPs trying the
new rechargeable version of miniRITE T, the miniRITE R.
5) Risk (safety) E.g., no risk identified in the use of this device (or state risk and the mitigation to resolve
the risk in risk analysis)
6) Conclusion Render evidence for performance:
It is concluded that Oticon Opn S 1 represented by BTE PP and miniRITE R as a complete
and final product works well in the user’s everyday life, and that it outperforms Opn 1 in
this validation.
Render evidence for safety:
No safety issues were addressed in the paper.
Table 30: Clinical data from Opn S miniRITE R: Usability

Study U1
Nøhr Demant, L. (2019). Usability Engineering Report for Marvel 19.1 P232 Oticon Opn S, Opn Play - miniRITE R
1) Objective To report the usability engineering process conducted for Magneto (i.e., the Oticon Opn
S 1 miniRITE R rechargeable hearing aids (HIs) and charger) as a part of the product
development.
2) Design Different user scenarios were tested: fitting and dispensing, charging, everyday use,
flight mode, maintenance and troubleshooting.
3) Population 30 HI-experienced lay users and 30 HI-naïve lay users (children, adults and elderly)
4) Performance A summative usability test was conducted, demonstrating that intended users are able to
use the product safely and effectively without patterns of preventable use errors or
difficulties that could result in serious harm to the user
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Based on the findings from the summative usability test, a residual risk assessment was
conducted by considering the findings in the overall risk assessment. No patterns of
preventable use errors or difficulties, which could result in serious harm to the user,
were identified in the study. The residual risks were deemed acceptable, since the
remaining residual use-related risks are outweighed by the benefits derived from using
the product.
The clinical data of each study has been separated into the three performance/benefit domains
(amplification, speech perception and quality of life) as well as safety domain, see Table 31 and Table 32.
Table 31: Validation data (V1) from Opn S 1 in terms of performance and safety outcomes
Domain
Amplification Opn S 1 is fitted on each patient using their individual hearing loss. The average hearing loss
(performance) for the group at the speech important frequencies (1, 2 and 4 kHz) is 59 dB HL.
For each patient, the fitting software is used to calculate an individual prescription based on
simulated properties of the ear. The prescription is expressed in insertion gain and the 95%
confidence interval at speech important frequencies (1, 2 and 4 kHz) and conversational
speech levels (65 dB SPL) is 18,8 to 26,3 dB. Since it exceeds 0 dB, the device claim on
amplification has been demonstrated.
Speech perception Since the insertion gain at speech important frequencies are larger than 0, then the SII
(performance) benefit is also larger than 0. In other words, the benefit of speech can be ensured. SII benefit
was estimated based on the average hearing loss using the VAC+ default rationale in Oticon
Opn S1. The Oticon Opn S 1 BTE PP the 4 pure tone average hearing loss (500 Hz, 1kHz, 2kHz,
4kHz) was 67,5 dB HL for both ears individually, the unaided SII was 1% and the aided SII was
45%, leading to an SII benefit of 44%. For the Oticon Opn S 1 MiniRITE R T the 4 tone average
hearing loss (500 Hz, 1kHz, 2kHz, 4kHz) was 40dB HL and 42,5 dB HL for the right and left
ears individually, the unaided SII was 43% and 40% and the aided SII was 74% and 68%,
leading to an SII benefit of 31% and 28%.
The results from the (100 point) questionnaire shows that Opn S 1 is rated significantly
better than the benchmark device Opn 1 (predecessor) for speech intelligibility with an
improvement for Opn S 1 over Opn 1 from (V1) on 15.8 RU for speech intelligibility. The
absolute score for the test device Opn S 1 (O1) was 69 RU for speech intelligibility.
Quality of life Since the unaided score was not collected in this study, clinical benefit will be established
(clinical benefit) based on a comparison to normal hearing listeners. Juul Jensen, 2018, compares data from
two published studies, Ohlenforst et al 2018 and Wendt et al 2018, reporting on speech
understanding in noise and the related objective listening effort as assessed via
pupillometry. In both studies, Oticon Opn 1 was used. Juul Jensen 2018 finds that there are
substantial gaps between the performance of the listeners with normal hearing and the
listeners with hearing impairment, using hearing aids, when the hearing aids only use
amplification, in terms of both speech understanding in noise and listening effort. However,
when activating the help systems in Opn 1 that ease understanding of speech in noise, the
gaps in speech understanding and listening effort are closed. Thus, hearing aids now have a
performance in some situations (similar to those reported on by Juul Jensen) that makes
people with hearing loss able to understand speech at a level that is comparable to their
normal hearing peers.
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Having established that Oticon Opn 1 provides substantial increases in speech understanding
in noise (item 4 above) and also observing a subjective improvement in speech intelligibility
of Oticon Opn S 1 over Oticon Opn 1 (item 3 above) shows that Oticon Opn S 1 provides a
significant clinical benefit in terms of speech intelligibility.
Safety Hearing aid was fitted on each patient using their individual hearing loss including a
prescription of the maximum power output. Since maximum power output is not verified
directly on the patient but instead is very accurately simulated in the fitting software (in-situ
output), it is shown that the maximum power output (MPO), using a pure tone signal at 90
dB SPL does not exceed 123 dB SPL (85: miniRITE T) and 128 dB SPL (105:BTE PP). Since the
speaker level for the validation test was both 60/85 as well as 105, the maximum power
output has the potential to exceed the limit of 132 dB SPL. However, for the most severe-to-
profound user in this test, the MPO did not exceed 132 dB SPL. For all three kinds of speaker
levels and patient hearing losses used in this study, the requirements on safety using existing
clinical data has been met.
Table 32: Usability data (U1) from Opn S 1 in terms of performance and safety outcomes
Domain
Amplification Hearing aid was fitted on each patient using their individual hearing loss, although they were
(performance) never verified in terms of speech perception and tried out in their home environment.
Speech perception NA
(performance)
Quality of life NA
(clinical benefit)
Safety Hearing aid was fitted on each patient using their individual hearing loss including a
prescription of the maximum power output.
Of the two studies, the validation data (V1) provide the most complete data set in terms of performance and
safety. In terms of study design and outcome as has the following experimental qualities:
• The study design was based on a comparative non-blinded cross-over paradigm in the field.
• Sample size was determined through statistical power analysis based on previous development
testing
5.2.2 Device under evaluation
Two clinical studies on More 1 have been identified and included in this clinical evaluation. Below is a
summary of own clinical data for the device under evaluation More 1
Two types of data are available. Validation data (V),Table 33 and Usability data (U), Table 34.
Table 33: Clinical data from More 1: Validation

Study V2
Bramsløw, L; Iven, M. (2020) More Clinical Evaluation Report
1) Objective The purpose was to validate the user requirements regarding the performance
(effectiveness) of the final More 1 product
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2) Design Cross over design (unbalanced) with test HA (Oticon More 1) vs. reference HA (Oticon
Opn S 1) in a three weeks field trial. There is one style and three fitting levels enrolled in
the trial: More 1 miniRITE R 60/85/105. Three outcome measures were used: 1)
Dantale2 in noise speech intelligibility test (laboratory), 2) SSQ12 absolute rating of
reference HA, SSQ12-C comparative rating of test HA compared to own HA and 3) IOI-HA
rating of test HA.
3) Population 21 adults with hearing impairment average age of 65,8 y (43-77y)
4) Performance Speech intelligibility: Compared to unaided, the Oticon More changed the speech
reception threshold (SRT) in noise (dB SNR) by -5.2 dB (p<0,0001), which is an
improvement. Compared to Opn S , More 1 changed the SRT by -0.7 dB, which was not
statistically significant on the p = 0.05 critical level.
SSQ: Absolute ratings (SSQ12) of reference HA were consistently above literature data.
Relative ratings of the test HA (SSQ12-C) were consistently above 0, mean = 1.15 on a +/-
5 scale (p < 0.0001).
IOI-HA: The IOI-HA-7 (Quality of Life improvement) item was on average 3.5 (label:
‘quite a lot’) on a 1-5 scale, which is within norms.
It is concluded that Oticon More 1 represented by miniRITE R as a complete and final
product works well in the user’s everyday life, and that it outperforms Opn S 1
No safety issues were addressed in the study.
Table 34: Clinical data from More 1 miniRITE R: Usability

Study U2
Robertson, A. (2020) Usability Engineering report for Polaris 20.2 P234 Oticon – miniRITE-R
The usability report for Polaris refers back to the Usability Engineering Report for Marvel 19.1 P232 Oticon Opn
S, Opn Play - miniRITE R as no new clinical usability testing was conducted on the HA, because the hardware
for More 1 is the same as used for Opn S 1.
1) Objective To report the usability engineering process conducted for Magneto (i.e., the Oticon Opn
S 1 miniRITE R rechargeable hearing aids (HIs) and charger) as a part of the product
development.
2) Design Different user scenarios were tested: fitting and dispensing, charging, everyday use,
flight mode, maintenance and troubleshooting.
3) Population 30 HI-experienced lay users and 30 HI-naïve lay users (children, adults and elderly)
4) Performance A summative usability test was conducted, demonstrating that intended users are able to
use the product safely and effectively without patterns of preventable use errors or
difficulties that could result in serious harm to the user
Based on the findings from the summative usability test, a residual risk assessment was
conducted by considering the findings in the overall risk assessment. No patterns of
preventable use errors or difficulties, which could result in serious harm to the user,
were identified in the study. The residual risks were deemed acceptable, since the
remaining residual use-related risks are outweighed by the benefits derived from using
the product.
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The clinical data of each study has been separated into the three performance/benefit domains
(amplification, speech perception and quality of life) as well as safety domain, see Table 35 and Table 36for
the two studies.
Table 35: Validation data (V2) from More 1 in terms of performance and safety outcomes
Domain
Amplification More 1 is fitted on each subject tested using their individual hearing loss. The average
(performance) hearing loss for the speech important frequencies of 0.5,1, 2 and 4 kHz (PTA4) was for the
group of subjects 47.7 dB HL (SD 15.6 dB HL) for the right ear and 48.3 dB HL (SD 15.3 dB HL)
for the left ear.
For each subject, the fitting software is used to calculate an individual prescription based on
simulated properties of the ear. The prescription is expressed in insertion gain. The mean
value for REIG is for both ears across all subjects 16 dB with a range from 7 dB to 24 dB for
the frequencies 0.5 to 4 kHz . Since it exceeds 0 dB, the device claim on amplification has
been demonstrated.
Speech perception Since the insertion gain at speech important frequencies are larger than 0, then the SII
(performance) benefit is also larger than 0. In other words, the benefit of speech can be ensured. SII benefit
was estimated individually for each subject based on the unaided SII for their hearing loss
and the aided SII achieved by using the VAC+ default rationale in Oticon More 1. The unaided
SII average was 35% (SD 24.9 %) for the right ear and 35,1% (SD 22.3 %) for the left ear. The
average aided SII was however 60% (SD 16,8 %) for the right ear and 62,5% (15.5 %) for the
left ear, leading to an SII benefit of 25% (SD 13,3%) and 27,4% (SD 14,0%) for the right and
left ear respectively.
In the lab, by using Dantale II, speech perception was demonstrated to be statistically
significant better in noise with the amplification provided by Oticon More 1 compared to
unaided, and the speech reception threshold (SRT) is improved by -5.2 dB SNR (p<0.001).
Comparing to Opn S 1, Oticon More improved the SRT by -0.7 dB SNR, but this difference is
not statistically significant.
Quality of life The results from the SSQ-C questionnaire shows that More 1 is rated significantly better than
(clinical benefit) the reference device Opn S 1 (predecessor). The average difference on the SSQ is 1.15 (95%
CI 0.73-1.57) in favor of More 1. The difference is statistically significant above 0 (t (20) =
4.71, p < 0.0001, d = 1.15) showing an overall improvement of More 1 over Opn S 1. At the
same time, the initial absolute SSQ12 rating of the Opn S 1 reference device was consistently
above norm data (Cañete et al 2020), indicating that More 1 provides a high benefit.
The IOI-HA asks a specific question (IOI-HA 7) about the improvement of quality of life (QoL)
from using hearing aids. The scoring is based on a 5-point Likert scale with 5 being the best
answer. The normative values for the IOI-HA for the QoL benefit are 3-4. The average
response from the subjects tested was 3.5 which is within the reported norms (Cox et al,
2003).
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Having established that Oticon More 1 provides a substantial increase in speech

understanding in noise over no hearing aid (unaided) and also subjective improvement in
speech, spatial, and qualities of hearing (SSQ 12) of More 1 over Opn S 1, it shows that
Oticon More 1 provides a significant clinical benefit in terms of speech intelligibility.
Furthermore, the IOI-HA questionnaire demonstrated ‘quite a lot’ on ‘Quality of life
improvement’, when judging the overall benefit of the hearing aid.
Safety Hearing aid was fitted on each subject using their individual hearing loss including a
prescription of the maximum power output. Since the selected speaker level for the
validation test, depending on the hearing loss of the subject, was both 60, 85 or 105, the
maximum power output has the potential to exceed the limit of 132 dB SPL. The maximum
power output has not been verified directly on the subject but has instead very accurately
been simulated in the fitting software Oticon Genie vers. 20.2 (in-situ output). By using a
pure tone signal at 90 dB SPL, it has been shown that the maximum power output (MPO)
does not exceed 132 dB SPL. For all three kinds of speaker levels and all hearing losses used
in this study, the requirements on safety using existing clinical data has been met.
Table 36: Usability data (U2) from More 1 in terms of performance and safety outcomes
Domain
Amplification Hearing aid was fitted on each patient using their individual hearing loss, although they were
(performance) never verified in terms of speech perception and tried out in their home environment.
Speech perception NA
(performance)
Quality of life NA
(clinical benefit)
Safety Hearing aid was fitted on each patient using their individual hearing loss incuding a
prescription of the maximum power output.
Of the two studies, the validation data (V2) provide the most complete data set in terms of performance and
safety. In terms of study design and outcome it has the following experimental qualities:
• The study design was based on a comparative non-blinded cross-over paradigm in the field.
• Sample size was determined through statistical power analysis based on previous development
testing and norm data found in the literature.
Clinical Data of Tinnitus SoundSupport feature
Below is a summary of own clinical data for sound therapy support. There are two validations available, Table
37 and Table 38.
Table 37: Clinical data from Alta2 Pro Ti: Validation on tinnitus sound support
Study T1
Hafrez, A (2015), Validation Results Report – Oticon for Eclipse+ P140
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1) Objective The purpose of this test is to validate if Tinnitus Sound Support tool with regard to
providing relief from tinnitus
2) Design Cross over design with test HA (Oticon Alta2 Pro Ti) vs reference HA (Alta2 Pro) in a 5
weeks long field test. All test persons were fitting with a broadband sound program and
an ocean sound program based on individual preferences.
3) Population 11 adults with hearing impairment and tinnitus with average age of 61 y (47-75y)
4) Performance After the trial period, test persons rated their tinnitus as less bothersome using Tinnitus
Handicap Inventory (THI). There were no reports on worsened tinnitus with the sound
generator on. Ten out of eleven test persons could see the long term value in using the
Tinnitus sound generator for their tinnitus.

These results demonstrate the Tinnitus Sound Generator can provide relief for tinnitus
for end-users with mild to severe tinnitus and is a valuable part of tinnitus treatment.
Table 38: Clinical data from Opn 1: Validation on tinnitus sound support
Reference T2
Hafez, A (2017), Usability Engineering Report for Marvel 20.1
1) Objective The overall purpose of this test was to validate Opn 1 miniRITE incl. Tinnitus Sound
Support
2) Design Cross over design with test HA (Oticon Opn 1) vs reference HA (Alta2 Pro Ti) in
approximately 2 weeks long field test. All test persons were fitting with a broadband
sound program and a ocean sound program based on individual preferences.
3) Population 11 adults with hearing impairment and tinnitus with average age of 62 y
4) Performance 10 of the 11 TPs (91%) preferred Opn 1 with tinnitus sound support.to their own HI with
former generation of tinnitus sound support. Opn 1 had significantly lower THI score
than Alta2 Pro Ti which imply more relief of tinnitus for the Opn 1 device.

In conclusion, Opn 1 as a combination device works extremely well in the user’s everyday
life and outperforms Alta2 Pro Ti in regards to speech intelligibility and providing relief
from tinnitus. Testpersons could see the long-term value of using Opn 1 incl. TSS.
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Both clinical studies has been separated into the two domains, Table 39 and Table 40:
Table 39: Validation data (T1) from Alta2 Pro Ti in terms of performance and safety outcomes for tinnitus
sound support
Domain
Audibilty (performance) Alta2 Pro Ti is fitted on each patient using their individual hearing loss. A
broadband Tinnitus relief sound was prescribed. The choice of broadband
sound was made individually.
For each test person, the fitting software is used to calculate an individual
prescription based on the preferred relief sound.
The audibility of the tinnitus relief sound prescription is expressed in how
much of the noise that exceeds the threshold of hearing for each individual.
The average audible bandwidth expressed as 95% confidence interval, is 1,2 –
1,6 octave. Since it is wider than 1,0 octave, the device claim on audibility has
been demonstrated.
Relief of tinnitus (clinical benefit) The results from the THI questionnaire shows that Alta2 Pro Ti provides
significantly relief from tinnitus compared to the hearing aid alone. Clinical
benefit has then been demonstrated.
Safety Since the overall output level of the tinnitus relief sound is not verified directly
on the patient but instead very accurately simulated in the fitting software.
The highest output of the tinnitus relief sound seen for one of the users in the
study, was 77 dB A. Since the maximum level of tinnitus relief sound do not
exceed 90 dB A the requirements on safety using existing clinical data has been
met.
Table 40: Validation data (T2) from Opn 1 in terms of performance and safety endpoints for tinnitus sound
support
Domain
Audibility (performance) Opn 1 with tinnitus sond support is fitted on each patient using their individual
hearing loss. A broadband Tinnitus relief sound was prescribed. The choice of
broadband sound was made individually.
For each test person, the fitting software is used to calculate an individual
prescription based on the preferred relief sound.
The audibility of the tinnitus relief sound prescription is expressed in how
much of the noise that exceeds the threshold of hearing for each individual.
The average audible bandwidth expressed as 95% confidence interval, is 2,5 to
2,9 octave. Since it is wider than 1,0 octave, the device claim on audibility has
been demonstrated.
Relief of tinnitus (clinical benefit)) The results from the THI questionnaire shows that Opn 1 as a combination
instrument with tinnitus sound support provides significantly relief from
tinnitus compared to the former version of the combination device, Alta2 Pro
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Ti. From an earlier validation study (T1) with Alta2 Pro Ti, a significant relief of
tinnitus was demonstrated compared to the hearing aid alone. Clinical benefit
has then been demonstrated.
Safety Since the overall output level of the tinnitus relief sound is not verified directly
on the patient but instead very accurately simulated in the fitting software.
The highest output of the tinnitus relief sound seen for one of the users in the
study, was 71 dB A. Since the maximum level of tinnitus relief sound do not
exceed 90 dB A the requirements on safety using existing clinical data has been
met.
Post-market surveillance data
Demant HIG has a procedure in place to cover the Post-market Surveillance (PMS) activities, see DOC-0526
SOP – Post-market surveillance. The PMS Plan, see Post Market Surveillance Plan for Oticon – More, Doc. No
0901c76e809d5559) contains a full description of what information are relevant for the PMS analysis. The
contribution from the clinical evaluation to PMS for Oticon More is planned to include an updated literature
review (if needed), a review of Oticon, Bernafon, Sonic and Philips’s complaint databases as well as a review
of the major medical device vigilance databases worldwide.
After product launch a PMS report will be created based on the PMS data described in the PMS plan and no
later than two years after product release a Periodic Safety Update Report (PSUR) will be formed. The PMS
System is based on several reactive and proactive inputs, and the PSUR is showing a summary of those with
focus on health and safety. Each input is running individually and have their own process. The PSUR collects
data from all the processes and analyze if any health and safety issues have been identified for the product(s)
in scope.
5.4.1 Complaints
To assess risks and hazards and to contribute to the benefit-risk determination for Oticon More miniRITE R
from the new Polaris project product release, the sales numbers, related complaint numbers and their
percentage rate of occurrence are investigated and specified in the following section. The investigation is
done for all brands from Demant HIG, that have been released under the predecessor Marvel project,
including Model 1 (Oticon) and Model 2 (Bernafon, Sonic, Philips) and Model 1 and 2 together. The Marvel
project had two product releases including the miniRITE style (Oticon Opn S in 19.1 and Oticon Ruby in 20.1).
The miniRITE R styles for both development projects – Marvel and Polaris – are the same and the complaints
seen from Marvel are seen to be equivalent to what may be expected as complaint rate for Oticon More
miniRITE R.
The Demant HIG has internally set a success threshold for complaint handling of ≤ 0,5% for the accumulated
complaint % after 12 months.
Products investigated:
To investigate the complaints in depth, two sets of tables are shown in the following – first a table covering
the product style “miniRITE” all versions from Model 1 and Model 2 specific and both Models together. This
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table is followed by a table specifying the complaints for the fully featured Oticon Opn S1 and Ruby 1 product
versions. The miniRITE R style is the rechargeable version within the two Oticon families Opn S and Ruby. It
differs technically from the other miniRITE styles only by the provided rechargeability. Oticon More miniRITE
R is the specific miniRITE style in focus of this product release.
Model 1 Model 2
Development project Marvel
Brands Oticon Bernafon, Sonic, Philips
HA families Opn S, Ruby Viron, Captivate, HearLink
HA styles miniRITE, miniRITE T, miniRITE T R
Price points all all
Specifically, as a subgroup from Model 1: Ruby 1 miniRITE and Opn S 1 miniRITE:
Opn S, Ruby More

miniRITE with T-coil miniRITE T --
miniRITE with T-coil miniRITE R miniRITE R
rechargeable
RITE mini miniRITE --
Technically seen, the hearing aid style “miniRITE” includes the versions miniRITE (basic version), miniRITE T
(with telecoil) and miniRITE T R (with telecoil and rechargeable battery).
Sales numbers for miniRITE styles from Marvel project since product release (status 2020-11-03)
Model 1 Model 2 Model 1 + 2

Sale 1.400.046 219.408 1.619.454
Sale MiniRITE T 94.189 18.040 112.229
Sale MiniRITE T R 766.956 121.421 888.377
Sale RITE mini 538.901 79.947 618.848
Specifically, for Oticon Opn S 1 and Ruby 1:
Opn S 1 Ruby 1
Sale 653.223 48.567
Sale miniRITE T 50.623 2.628
Sale miniRITE R 394.573 26.543
Sale miniRITE 208.027 19.396
Sum of complaints registered for miniRITE style from Marvel project since product release (status 2020-11-
03)

Complaints 4.400 495 4895
Complaint % of sale 0,31% 0,22% 0,30%
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Specifically, for Opn S1 miniRITE R and Ruby 1 miniRITE R / rechargeable miniRITE styles:
Opn S 1 miniRITE R Ruby 1 miniRITE R

Complaints 6.635 36
Complaint % of sale 1,58% 0,13%*
* lower %-rate of complaints for Ruby 1 miniRite R demonstrates that Ruby miniRITE R was first released after problems with the
charger impacting the high complaint rate for Opn S1 miniRite R were solved.
Results from investigating the Demant HIG complaint system are subdivided in complaints related to the
subgroups: Acoustical, Electrical, Lithium Ion batteries, Marketing & Logistics, Mechanical & Assembly,
Potential health or safety risk, Programming & Connection, Visual, Wireless.
All complaints that may be related to hazards listed in the risk assessment (risks with moderate or significant
severity before mitigation are listed Table 46 and Table 47 in this document) or that have been assessed to
be able to create a potential health and safety risk are registered in that part of the complaint system. If a
complaint from that group after a thorough investigation is found to create a health and safety risk, a
vigilance case is created as consequence.
Complaint numbers related to potential health risks & vigilance cases from Marvel project since product
release (status 2020-11-03)

Complaints - Potential health or safety risk 14 3 17
Complaints - Potential health or safety risk % of 0,001% 0,001% 0,001%
sale
Subset of these complaints investigated due to 2 1 3
high output level of the device > 132 dB
Subset of these complaints identified with high 0 0 0
output level of the device > 132 dB
Vigilance case identified 0 0 0
Specifically, for Opn S 1 miniRITE and Ruby 1 miniRITE:
Opn S1 Ruby 1
Complaints - Potential health or safety risk 8 0
Complaints - Potential health or safety risk 0,00% 0,00%
% of sale
Subset of these complaints investigated 2 0
due to high output level of the device >
132 dB
Subset of these complaints identified with 0 0
high output level of the device > 132 dB
Vigilance case identified 0 0
The Oticon More (Model 1) miniRITE R style in focus of this Clinical Evaluation Report is the rechargeable
version within the miniRITE hearing aid style. Therefore, sales numbers and the specific complaints from the
Marvel project miniRITE R styles related to that technology have been considered separately.
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Sales & complaints related to rechargeable style miniRITE T R from Marvel project since product release
(status 2020-11-03)

Sale MiniRITE T R 766.956 121.421 888.377
Complaints - Rechargeable 2.189 153 2.342
Complaint - Rechargeable % of sale 0,29% 0,13% 0,26%
rechargeable
Specifically, for Opn S 1 miniRITE R and Ruby 1 miniRITE R:
Opn S 1 Ruby 1
Sale miniRITE R 394.573 26.543
Complaints - Rechargeable 1588 13
Complaint - Rechargeable % of sale 0,40% 0,05%
rechargeable
Oticon Opn S (Model 1) shows a higher %-rate of complaints related to the rechargeability of miniRITE T R
than Oticon Ruby miniRITE R from Model 1 and all Model 2 miniRITE R styles release from the Marvel project.
This is due to the reason that the rechargeable version of miniRITE was first released with Oticon Opn S and
the charger delivered with the Opn S could be identified as the root cause for a high number of complaints
related to rechargeability within the first months after release. The identified problem was mitigated by a
design change on the charger. Oticon Ruby (Model 1) and the Model 2 rechargeable miniRITE T R styles were
first sold to the market with a later release. After the design change on the charger device was implemented
(June 2019), the complaint numbers decreased significantly. The complaint rate in % for Model 2 is lower
than for Model 1 as the %-rate for Model 1 contains the high numbers of complaints before mitigation. The
trending of complaint numbers from Model 1 shows the change of numbers of complaints on Model 1
miniRITE T R after the design change for the charger was implemented.
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Model 1 Complaints related to rechargeability / caused by the charger (status 2020-11-03):
Complaints in numbers and percentage related to sales numbers in categories for the miniRITE style from
Marvel project since product release (status 2020-11-03):

Complaints in category:
Acoustical 603 109 712
Acoustical % 0,04% 0,05% 0,04%
Electrical 1.793 139 1.932
Electrical% 0,13% 0,06% 0,12%
Lithium Ion Battery 583 34 617
Lithium Ion Battery % 0,04% 0,02% 0,04%
Marking & Logistics 83 28 111
Marking & Logistics % 0,01% 0,01% 0,01%
Mechanical & Assembly 267 70 337
Mechanical & Assembly % 0,02% 0,03% 0,02%
Programming & Connection 939 100 1.039
Programming & Connection % 0,07% 0,05% 0,06%
Visual 11 0 11
Visual % 0,00% 0,00% 0,00%
Wireless System 104 12 116
Wireless System % 0,01% 0,01% 0,01%
Specifically, for Opn S 1 miniRite R and Ruby 1 miniRite R (status 2020-11-03):
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Opn S 1 miniRite R Ruby 1 miniRite R

(released 19.1) (released 20.1)
Complaints in category:
Acoustical 1 1
Acoustical % 0,000% 0,004%
Electrical 215 0
Electrical% 0,054% 0,000%
Lithium Ion Battery 1.269 0
Lithium Ion Battery % 0,322% 0,000%
Marking & Logistics 416 0
Marking & Logistics % 0,105% 0,000%
Mechanical & Assembly 35 0
Mechanical & Assembly % 0,009% 0,000%
Programming & Connection 1 9
Programming & Connection % 0,000% 0,034%
Visual 9 0
Visual % 0,002% 0,000%
Wireless System 526 19
Wireless System % 0,133% 0,072%
Conclusion:
Based on the percentage of customer complaints in relation to sales seen from products equivalent in style
and technical function with the same intended use and intended user group as for Oticon More miniRITE R, it
can be concluded that, the Oticon More miniRITE R style is safe to use with no vigilance cases and no new
side effects identified. The very limited amount of complaints contributes positively to the overall benefit-
risk determination of the product.
Post-market clinical follow-up data
5.5.1 Generic process description

Process
Demant has a procedure in place to cover post-market clinical follow-up activities (DOC-0553 SOP Post-
market Clinical Follow-up). Typically, twice a year the Demant HIG releases a bundle of products within their
four HA brands Oticon, Bernafon, Sonic and Philips. To plan the relevant post-market clinical follow-up
activities, a Post-market Clinical Follow-up Plan (PMCF-Plan) is developed together with every product
release – consequently every half year a new PMCF-Plan is made. The PMCF-Plan contains post-market
activities related to the products released together with it, but also follows up on complaints that have been
flagged as Vigilance Cases (DOC-0410 GOP – Complaints and Vigilance) or have initiated a design change in
any product that may affect clinical performance or was made to be a solution to minimize an identified
safety risk (DOC-0052 SOP Design Change).
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For all PMCF investigations with focus on hearing aid performance and benefit, the three main performance
outcomes to clinical benefit already listed for the clinical evaluation of the product in section 3.1.6 will be
taken up for PMCF data collection:
1. Improving hearing through audibility
2. Speech intelligibility outcome
Table 41: Endpoints and outcome data to support clinical performance outlined in the IFU
endpoints outcomes
Indication of Use IFU
for clinical performance to collect relevant data
1 amplification provided by the select fitting rationale Intended Use: The hearing aid
HA is intended to amplify and
transmit sound to the ear.
1a deviation of HA output/gain
from target values or the
RMSE for relevant
frequencies (standard: 0.5, 1,
2, 4 kHz)
2 Audibility of speech achieved Real ear measurement (REM)

by amplification will be used to verify audibility
achieved by amplification.
The Speech Intelligibility
Index SII (ANSI S3.5 1997
R2007):
- unaided SII (without HA)
- aided SII (with HA)
2a SII benefit SII(aided) - SII(unaided) = Clinical benefit: The hearing
SII(benefit) > 0 aid is designed to provide
The SII-benefit provided by HA better speech understanding
amplification should be more to help ease communication
than 0. with the aim of improving life.
2b SII aided vs. normative SII Aided SII for normal speech
ranges level (65 dB) compared with
published normative ranges.
3 Measured benefit of Lab test data (if applicable)

individual speech
intelligibility in quiet and
noise
4 Self-reported listening Validated questionnaires for
benefit self-reporting, e.g. SSQ-12,
SSQ-12B, SSQ12C, APHAB or
other
5 Quality of Life QoL (hearing) International Outcome
Inventory for Hearing Aids:
IOI-HA
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Audibility
Best practice/State-of-The-Art principles for provision of hearing aids to meet requirements are the baseline
for PMCF investigations with hearing aids. Real-ear measurement (REM) of hearing aid gain and output in the
individual ear to investigate audibility by the increase of Real-Ear Insertion Gain (REIG) or Real-Ear Aided
Response (REAR). The Speech Intelligibility Index SII (ANSI S3.4 1997_U2004) will be calculated without
hearing aid SIIunaided and with hearing aid gain SIIaided for speech at normal level 65 dB to collect data on the SII
benefit (SIIbenefit = SIIaided – SIIunaided). Finally, the individually achieved aided SII can be compared with the
published normative ranges for the SII related to adult and pediatric hearing aid fitting.
Speech Intelligibility outcome

Whenever evaluated speech tests that could be used in free field via loudspeaker to evaluate speech
discrimination with hearing aids in quiet and noise are available and part of the standard clinical approach in
the country selected to run a PMCF study, data related to the speech discrimination outcome and benefit
with hearing aids will be collected.
Self-reported outcomes
Validated questionnaires to collect self-reported outcomes in relation to listening benefit and quality of life
improvement are also part of the baseline in PMCF investigations and always considered. The International
Outcome Inventory for Hearing Aids (IOI-HA) has been translated and evaluated in many international
languages. Therefore, the IOI-HA will be selected to accompany the data collection of every PMCF
investigation related to hearing aid performance and results will be part of the statistical analysis of the data.
Depending on the specific interest of the PMCF investigation in terms of performance of hearing aids, further
validated questionnaires for self-reported listening benefit and quality of life will be used. Potentially special
purpose questionnaires will be added if the investigation is focusing on a certain hearing aid feature or fitting
condition, and more specific post market input is needed. Results will be analyzed by means of the most
appropriate statistics, following the clinical research questions identified for the post market investigation.
Best practice/State-of-The-Art fitting procedure used in PMCF investigations:
1. The actual device is fitted on each patient using their individual hearing loss. The unaided SII is calculated
from the audiogram (SIIunaided).
2. For each patient, the fitting software is used to calculate an individual prescription based on simulated
properties of the ear.
3. This first fitting for each patient is verified using real-ear measurement REM and – if neccessary in the
individual case – finetuned to the individual dimensions of the ear canal and the acoustic coupling to the
ear impacting gain and output in the individual ear. The aided SII is calculated (SIIaided).
4. The SII benefit is calculated based on unaided and aided SII score to demonstrate the expected increase in
speech intelligibility due to the audibility of speech cues provided by amplification.
(SIIbenefit = SIIaided – SIIunaided > 0)
5. The achieved aided SII value can be related to the individual PTA4 (0.5, 1, 2, 4 kHz) and evaluated in
comparison to the normative range of SII for the same PTA4 for hearing aid fitting in adults published
from research.
6. Speech discrimination benefit in quiet and in noise environments is measured as a difference between
aided and unaided score whenever this is an option in the country and market involved in the PMCF
investigation.
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7. As final outcome measure, the hearing aid fitting is validated through a version of the (validated) Speech,
Spatial and Quality questionnaire SSQ or another relevant validated questionnaire – filled-out once before
the HA fitting and then after the HA fitting including an adequate period of individual acclimatization to
the HA amplification.
8. The International Outcome Inventory for Hearing Aids (IOI-HA) is used in all PMCF investigations to
evaluate the overall customer benefit in seven categories – use, benefit, residual activity limitation,
satisfaction, residual, impact on others, quality of live.
9. As the hearing aid fitting in the international market follows either “best practice/state-of-the art” fitting
procedures involving individual REIG/REAR based fitting (ca. 20%) or the estimated REIG/REAR approach
(ca 80%) supported by the hearing aid fitting software, this can also be reflected in the PMCF
investigations.
The PMCF process investigates the clinical performance and the safety of all classified products released to
the market, i.e. including products covered by this CEP. PMCF investigations can have an additional focus on
the outcome of a specific feature and can also incorporate a special focus on complaints that have been
reported from the market. The data reporting for PMCF investigations includes the possibility to directly
report any adverse events or complaints via the eCPR documents and the AE report activated in the cloud-
based data reporting software used for PMCF.
5.5.2 Planned PMCF activities related to More
From a clinical performance and safety perspective, all 4 hearing aid brands from Demant HIG are equivalent.
As the clinical evaluators have access to the full development documentation, we have assessed this from:
• All 4 brands use exactly the same platforms / chipsets
• All use the identical chipset firmware and embedded software
• Differentiation happens via product configuration to derive model 1 and model 2
Finally branding maps model 1 into Oticon and model 2 into Philips, Bernafon, and Sonic
As a consequence, PMCF activities are planned across all four brands and all price points based on the
following principles:
• Clinically we have only two models
• They only differ on a few characteristics that have no impact on clinical safety and performance
• We select the highest price point from which all the other price points are derived
• Therefore, all equivalent products can be represented by one product selected for clinical
investigation
Current PMCF-Plans PrR 20.2 includes following investigations:
1. PMCF investigation 01 / PMCF concept “Adult”: Oticon More 1 miniRITE R / UP-Study

• Clinical performance of Oticon More miniRITE R (Model 1)
2. PMCF investigation 02 / PMCF concept “Adult”: OLD Philips vs. Oticon Performance
comparison:
• Clinical performance of Philips HearLink 9030 miniRITE TR (Model 2)
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• Comparison of clinical performance outcome data with Philips HearLink 9030

miniRITE TR to outcome data with Oticon More 1 miniRITE R in the same
subject.
3. PMCF investigation 03 / PMCF concept “Pediatric”: 360 Directional Listening in
Children with Hearing Loss
• Oticon More 1 miniRITE R used in a study with children and adolescents 8 - 15
years of age
• Clinical performance data achieved in pediatric hearing aid fitting
4. Fitting software Genie 2 version 2020.2 (Model 1) is covered by the PMCF
investigations 01 to 03 through the hearing aid fitting process
5. Fitting software HearSuite 2020.2 (Model 2) is covered by the PMCF investigation 02
The Oticon RemoteCare App for remote fitting is already covered by:
• PMCF Plan PrR 19.1&19.2 PMCF investigation 06 / PMCF concept “Limited Scope”:
RemoteCare App
Safety data
A search for adverse events related to wireless hearing aids was performed on various medical device safety
databases using the search terms Oticon, Bernafon, Sonic, Philips, Phonak, Starkey, Widex, GN Resound, and
Sivantos. The search period covered the last 5 years. For further details, see the Clinical Evaluation Plan.
5.6.1 MAUDE search
A search in FDA’s MAUDE (Manufacturer and User Facility Device Experience) database was conducted on
25-11-2020. Retrieved hits were assessed manually. Results are shown in Table 42. Of the 81 hits concerning
wireless hearing aids, three records were related to the Oticon brand.
Table 42: Adverse Event Reports from MAUDE database

Device name Adverse Event Reports Relevant
Opn miniRITE/ Oticon MW5076457, Malfunction Not relevant due to no relation to wireless hearing
aids – related to the hearing aid charger and the users
averse against the supplier
Sensei BTE/ 6221073, Malfunction Root cause cannot be determined. Failure analysis
Oticon CQ9906
Pure Primax / MW5071169, injury on hearing Not relevant due to no relation to wireless hearing
Sivantos aids – related to the users averse against the hearing
aids.
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Pure 7 Mi/ MW5073578, Malfunction Not relevant due to no relation to wireless hearing
Sivantos aids – related to a broken tip.
Pure Primax / MW5073835, Malfunction Not relevant due to no relation to wireless hearing
Sivantos aids – related to a faulty assembly of the hearing aid
Pure Binax/ Sivantos MW5076586, Malfunction Dome in ear-canal

By design, domes ensure proper fit. Domes are soft
and easy to pull out. For Demant devices, safety tests
are performed to ensure that domes attached to the
hearing instrument can resist a pull force of 3N
without coming loose from the instrument
(requirement from EN 60601-2-66). Instructions in
using the hearing aid and attaching domes in
instructions for use, on dome packaging and on
website.
Pure Binax/ Sivantos MW5076587, Malfunction Dome in ear-canal

website.
Genius/ MW5086421, Injury Dome in ear-canal

Sivantos By design, domes ensure proper fit. Domes are soft
website.
Insio Nx ITC/ITE/ MW5087987, Malfunction Pairing problems. Details lacking.

Sivantos
Virto V70/ 3005085999-2016-00001, Material Shell fragments caused injuries of eardrum and inner
Phonak disintegration ear canal during accident. Not relevant due to no
relation to wireless hearing aids – related to an
physical accident
Virto Q90/ 1421524-2016-00001, Power Not relevant due to no relation to wireless hearing
Phonak source issue aids – related to a isolated event with not enough
details proved.
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Virto V90/ MW5076585, Malfunction Dome in ear-canal

Phonak By design, domes ensure proper fit. Domes are soft
website.
Virto V90/ MW5076584, Malfunction Dome in ear-canal

Phonak By design, domes ensure proper fit. Domes are soft
website.
Audéo B-Direct/ MW5091195, Malfunction Not relevant due to no relation to wireless hearing
Phonak aids – related to a repair issue
Unspecified device/ MW5063746, Injury Details of the event lacking.

Starkey
Unspecified device/ MW5068617, Malfunction Battery drainage. Details of root cause lacking
Starkey
Unspecified device/ MW5070259, Malfunction Hearing aids cause soreness and swelling and hurt.
Starkey Details of root cause lacking.
For Demant devices, it is known that the non-
allergenic materials used in rare cases may lead to a
skin irritation. This possible side effect has been
mitigated and documented in the IFU under warnings.
All material of housing is fully tested for
biocompatibility (EN ISO 10993-1:2009/AC: 2018).
Muse i2400/ MW5072287, Malfunction Not relevant due to no relation to wireless hearing
Starkey aids – related a repair issue
Muse i1600/ MW5077366, Injury Not relevant due to no relation to wireless hearing
Starkey aids – related to a repair issue
Muse RIC/ MW5088203, Injury Sound adjustment problems. Not relevant due to no
Starkey relation to wireless hearing aids – related to a repair
issue
Hearing aid charger/ 2125608-2020-00001, Malfunction Charger overheated causing part of the plastics to
Starkey melt, likely caused by the internal battery.
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For Demant devices, this is not relevant since we have

no charger with internal battery.
Lynx9/ MW5076582, Malfunction Dome in ear-canal

GN Resound By design, domes ensure proper fit. Domes are soft
website.
Lynx2/ 3005650109-2015-00002, injury Allergic reaction. Not possible to determine if the

GN Resound allergic reaction was caused by hearing aid itself or a
decease not related to the hearing aid.
Excelia Art/ MW5076583, Malfunction Dome in ear-canal

website.
Linx/ 3005650109-2015-00001 Dome in ear-canal

website.
Linx2/ MW5065596, Malfunction Dome in ear-canal

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website.
Linx2/ 3005650109-2017-00001 Swallowed hearing aid.

GN Resound For Demant devices, swallowing battery/instrument is
a known risk, and have been mitigated by risk control
measures, and residual risks are considered
acceptable
Lynx2/ 3005650109-2018-00001, injury Allergic reaction.

GN Resound For Demant devices, it is known that the non-
LINX 3D/ 3005650109-2018-00002, injury The speaker wire has irritated a wound on top of the
GN Resound ear eventually caused the reopening of the wound.
Not directly caused by hearing aid material.
LINX 3D/ 3005650109-2019-00001, injury Allergic reaction.

LYNX 2/ 3005650109-2019-00003, injury Allergic reaction

Enya/ 3005650109-2019-00006, injury Allergic reaction on one ear. Cause unclear. But the
GN Resound end user suffers from a lot of general allergic
reactions, but the pain from the hearing aid seemed to
be due to poor positioning and too long tubing being
used.
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Forte 8/ 3005650109-2019-00007, injury Dome in ear-canal

website.
Cala 8/ 3005650109-2019-00008, injury Dome in ear-canal

website.
Lynx 3D/ 3005650109-2019-00009 Reported ear infection after wearing the hearing aids
GN Resound for a few days. The infection disappeared after the use
of ear drops. Unclear what has caused the infection.
The ENT believes it could be the pressure in the ear
canal of the hearing aid.
Lynx2/ 3005650109-2019-00010 Dome in ear-canal

website.
Lynx2/ 3005650109-2019-00011 Ear reaction started after 2 days and was located
GN Resound around the first bend in ear canal. The ear reaction
disappeared after use of ear drops. Unknown cause
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Lynx 3D/ 3005650109-2019-00012 Sore/blister on right ear. The location of the symptom
GN Resound is in a place where neither instrument, receiver or
sports lock touches the skin. Unknown cause and
probably not related to hearing aid in itself.
Lynx 3D/ 3005650109-2019-00013 Infection/allergic reaction. end-user is experiencing

GN Resound itchy ears and sensitive ear canals on both sides. ENT
believes it is caused by infection/allergic reaction from
domes.
Lynx 3D/ 3005650109-2019-00015, injury Allergic reaction, showing as blistering, oozing and
GN Resound inflammation, to one of our devices after it has been
returned from repair. It is known that the end-user is
allergic to adhesives, among other things. The
manufacturer can document the biocompatibility
Lynx2/ 3005650109-2020-00001, End-user complained of hearing sharp almost painful

GN Resound malfunction intermittently sound in one or both ears. Incomplete
For Demant devices, it is known risk that sounds can
be too loud. This risk, has been mitigated by risk
control measures, and residual risks are considered
acceptable.
Preza 8/GN Resound 3005650109-2020-00002, injury Severe allergic reaction from the semi-open domes,
scaling of the skin. End-user has seen a doctor twice.
Antibiotics have been prescribed. Both ears were
affected.
Linx quatro/GN 3005650109-2020-00003, injury Patient reports a painfully loud squeal in his left ear.
Resound Patient reports pain for a day, which has gone away,
but now he also claim to have tinnitus, fullness, and
decreased hearing on that side. Hcp tested the
patient's hearing and his hearing has decreased by 10
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db at 1. 5 and 2 khz after this event. The hcp is

referring the patient to an ent.
Linx quatro/GN 3005650109-2020-00004, injury Repeated ear infections that never occurred prior to
Resound hearing aids Patient not wearing hearing aids until
infection clears since he wears w/o cleaning - he may
be re-introducing the fungus on unclean
domes/receivers.
Linx quatro/GN 3005650109-2020-00005, injury Possible allergic reaction. Patient developed a skin
Resound irritation/itching in outer ear canal from her ITE but
there were not openings (cuts or blisters) in the skin.
She reported to an urgent care for medication.
Medication was prescribed at urgent care, type of
medication unknown.
Preza 8/GN Resound 3005650109-2020-00006, , injury Ear infection claiming aids have caused it. Dispenser
will not refit until medical clearance has been given by
ent. Occurred with right hearing aid - ear infection
present - went to ent for diagnosis. Ent said it might
have been caused by "cross contamination of domes"
Linx quatro/GN 3005650109-2020-00007, injury Allergic reaction to the hearing aids. The hearing aids
Resound in question have blue paint which is chipping/flaking
off the bte device. The color chipping off is a known
issue related to the blue color but most likely not
related to the allergic reaction as both the paint and
the plastic material of the painted housing is fully
tested for biocompatibility.
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Lynx 3D/ 3005650109-2020-00008, injury Hearing aids suddenly get very loud and patient has to
GN Resound take the hearing aids off his ears. He is concerned that
it has affected his hearing. Occurred in both aids.
When he looks at his app it will show the volume is all
the way up. He has not touched his hearing aids. He is
currently in the ent office and will have his hearing
evaluated. Not completed
Lynx 3D/ 3005650109-2020-00009, injury The devices were "screaming at home and in office"
GN Resound and "feedback screaming". And as this is a ultrapower
device we want to investigate it to determine if the
device perhaps have malfunctioned and then
potentially could have caused harm to the hearing of
the patient. In completed
Linx quatro 7/GN 3005650109-2020-00010, injury A new device made a loud sound like a fire alarm
Resound lasting 5 seconds pt was first on 2020. no temporary
hearing loss or tinnitus and did not need to see a
doctor. The device has however not been returned
yet, possibly due to the corona situation. Incompleted
Linx quatro 9/GN 3005650109-2020-00011, injury Not reprogrammed to user settings information after
Resound repair
Preza 8/GN Resound 3005650109-2020-00012, injury Hearing aid makes "loud buzz". Complaint created.
Incompleted
Preza 8/GN Resound 3005650109-2020-00013, injury Dome in ear-canal

website.
Vida 8/ 3005650109-2020-00014, injury Switched side. No harm. Investigation not finalized.

GN Resound For Demant devices, left/right colour indicators are
found on the hearing aid itself, on speakers and on
some earpieces.
Forte 8/ 3005650109-2020-00016, Injury Loud sound after repair

GN Resound For Demant devices, it is known risk that sounds can
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acceptable.
Preza 8/ 3005650109-2020-00017, Event description missing

GN Resound Malfunction
Forte 8/ 3005650109-2020-00018, Injury Loud sound after repair

LYNX 3D/ 3005650109-2020-00019, Injury control measures, and residual risks are considered
GN Resound acceptable.
Preza 8/ 3005650109-2020-00020, injury Programming port rubbed sore spot on back of ear.
GN Resound Root cause unknown.
LYNX 3D/ 3005650109-2020-00021, Event description missing

LINX2/ 3005650109-2020-00022, injury Redness and swelling in both ears.

LINX Quatro 9/ 3005650109-2020-00023, injury Allergic reaction on top of ears

LINX Quatro 9/ 3005650109-2020-00024, Event description missing

LINX Quatro 7/ 3005650109-2020-00025, injury Overheating of device. Root cause unclear.

GN Resound
Unspecific device/ 3005650109-2020-00026, injury Redness and soreness in the right ear due to
GN Resound earmould.
LH561-DRW/ 3005650109-2020-00027, Injury Allergic reaction.

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Forte 8/ 3005650109-2020-00028, Injury Allergic reaction.

Beltone Boost 9/ 3005650109-2020-00029, injury Allergic reaction.

LINX Quatro 9/ 3005650109-2020-00030, injury Loud sound after repair

LYNX 3D/ 3005650109-2020-00031, injury control measures, and residual risks are considered
Verso 5/ 3005650109-2020-00032, injury
GN Resound
Vida 8/ 3005650109-2020-00033, injury Loud bong heard when watching tv. Root cause
GN Resound unknown.
acceptable.
LINX Quatro 9/ 3005650109-2020-00034, injury Loud sound after repair

LYNX 3D/ 3005650109-2020-00035, injury control measures, and residual risks are considered
LYNX 3D/ 3005650109-2020-00036, injury
GN Resound
Unspecific device/ 3005650109-2020-00037, injury Redness and flaking in the right ear due to earmould.
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LYNX 3D/ 3005650109-2020-00038, injury Loud sound after repair.

acceptable.
LINX2/ 3005650109-2020-00039, injury Medium open domes causing redness, swelling and a
GN Resound rash in both ear canals.
Forte 8/ 3005650109-2020-00040, Injury Skin irritation.

Enzo Q7/ 3005650109-2020-00041, Injury Loud popping sound.

acceptable.
Preza 8/GN Resound 3005650109-2020-00042, injury Loud sound after repair

acceptable.
Using the same search as above, a single record came up after manual filtration for tinnitus related events
from MAUDE, see Table 43.
Table 43. Adverse Event Reports from MAUDE database related to tinnitus
Phonak “Hearing MW5043596, Injuri Sleeplessness, insomnia, diarrhea.

aid maskers” Not relevant since event cannot be evaluated due to
lack of information.
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5.6.2 TGA search
A search in TGA’s (Australian Therapeutic Goods Administration) database of adverse event notifications –
medical devices was made 25-11-2020 with the same search criteria: Hearing aid, Oticon, Bernafon, Sonic,
Phonak, Sivantos, Starkey, GN Resound, Widex. The search filter “5 years” was activated, and a total of 7 hits
came from the search related to wireless hearing aids (Table 44).
Table 44: Adverse Event Reports from TGA database

Lynx 3D/ 48058 Dome in earcanal

website.
Unknown device/ 40483 Tubes not glued securely in earmold.

GN Resound Not relevant due to no relation to wireless hearing
aids – related to an incorrect produced or old earmold.
Unknown device/ 40484 Not relevant due to no relation to wireless hearing

GN Resound aids – related to an incorrect produced or old earmold.
Enya/ 58625 Allergic reaction. Root cause unknown.

Phonak - Virto q30/ 44633 Perceived dizziness during use.

Sonova Not relevant due to no relation to wireless hearing
aids – related to a isolated event with not enough
details proved.
Unknown device/ 58632 Not relevant due to no relation to wireless hearing

GN Resound aids – related to an incorrect produced or old earmold.
Muse i1200/ 55397 Skin reaction followed by a popping sound. Root cause
Starkey unknown.
No records came up after manual filtration for tinnitus related events from TGA.
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5.6.3 MHRA search
A search in MHRA (Medicines and Healthcare Products Regulatory Agency) database of adverse event
notifications – medical devices was made 25-11-2020 with the search criteria: Oticon, Bernafon, Sonic,
Phonak, Sivantos, Starkey, GNResound, Widex. This search also covered 5 years and yielded 2 hits related to
wireless hearing aids.
Table 45: Adverse Event Reports from MHRA database

Unspecified 2019/009/024/487/002 Voluntary Recall of Recently Serviced Hearing

GN Resound Aids due to a faulty user setting after repair. Time
frame August 14 and September 5, 2019.
Not relevant due to no relation to wireless
hearing aids in itself but rather to a repair facility
Unspecified 2017/008/030/291/021 No access to record

Starkey
No records came up after manual filtration for tinnitus related events from MHRA.
5.6.4 Health Canada search
A search in Health Canada database of adverse event notifications (Canada Vigilance Adverse Reaction
Online Database) was made 25-11-2020 with the search criteria: Hearing aid, Oticon, Bernafon, Sonic,
Phonak, Sivantos, Starkey, GNResound, Widex. The search filter “5 years” was activated, and a total of 0 hits
came from the search related to wireless hearing aids.
No records came up after manual filtration for tinnitus related events from Health Canada.
5.6.5 BfArM Search
A search in Federal Institute for Drugs and Medical Devices (BfArM, Germany) of adverse event notifications
was made 25-11-2020 with the same search criteria, which yielded 1 hit related to wireless hearing aids.
Table 40: Adverse Event Reports from BfArM database

Unspecified 12758/19 Voluntary Recall of Recently Serviced Hearing Aids due

GN Resound to a faulty user setting after repair.
Not relevant due to no relation to wireless hearing
aids in itself but rather to a repair facility
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No records came up after manual filtration for tinnitus related events from BfArM.
5.6.6 Summary
In summary, no safety issues were reported for the equivalent device Opn S 1 over the last 15 months, which
indicates a very favorable risk profile and supports the continued safe use of this technology for the More
family. Considering that this technology has been on the market for many years and offered by a large
number of manufacturers, it becomes clear that there is no outstanding risk relating to the use of wireless
hearing aids to take into consideration.
Performance and safety data retrieved from the literature
A systematic literature search was performed to identify relevant published articles to assess whether the
available body of clinical evidence supports the use of wireless hearing aids in general. The selection strategy
comprised two selection phases: During the first selection (abstract screening) four different criteria
wereapplied: population, device, review/surveys and language. In case the abstract information was not
enough, the specific information was collected through the full-text of the publication.
The second selection was done after a light review of the full-text of the publication. At first, to exclude
publications without commercial hearing aids. Letters to the editors, forwards, as well as review articles were
also excluded since they do not contain new data. Furthermore, laboratory studies, only using the device for a
few hours were excluded as well as studies using unspecified devices with a scope of investigating audiological
service and processes.
Using the significant keywords, “Hearing aid and benefit, amplification, satisfaction”, the search on PubMed
was divided between adults, children and unilateral hearing loss. A total of 1,421 publications were retrieved
in the search process. This first part of the literature search was performed according to the inclusion and
exclusion criteria described in the Clinical Evaluation Plan. In summary, 684 publications did not meet the
inclusion criteria and were excluded after the abstract review. 735 publications deemed to be within the
acceptance criteria were obtained and read. 670 publications were deemed to be outside of acceptance
criteria after reviewing the complete publication. The remaining 65 publications were appraised and
analyzed in the following. 47 articles contained data on adults and 18 on children (see 11.9.9).
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Figure 14: Overview of literature search results for adults
Figure 14 shows an overview of literature search results for adults. The search has been divided between
adults (A1&A2), and unilateral (U1), respectively, and is separated in the figure with a forward slash “/”.
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Figure 15: Overview of literature search results for children.
Figure 15 shows an overview of the literature search results for children. The search has been divided
children (C1&C2) and children (C3), respectively, and is separated in the figure with a forward slash “/”.
5.7.1 Hearing aids for adults
Fourteen studies were found having compelling or strong evidence. The evidence covers the three focus
areas of amplification, speech perception and quality of life.
One of the most important intervention with hearing aids for hearing impaired is the prescription of gain to
compensate for their hearing loss. While there already are plenty of less recent data on preferred real-life
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gain, little of this has been collected with current state-of-the-art hearing aids and with modern features
activated. Mueller et al. (2008) found that the generic fitting rationale NAL-NL1 tend to be preferred at a
slightly reduced setting when the hearing impaired has the possibility to adjust gain in real life. Convery et al.
(2011) investigated the impact of changing amplification compensation strategy, specifically for severe-to-
profound users. They suggested that a gradual change is a viable procedure for managing the transition to a
new and more appropriate gain/frequency response.
Bertozzo and Blasca (2019) conducted a study that indicated an equivalent performance between DSL v5.0a
and NAL-NL2 prescription procedures in HA adaptation in the elderly with hearing loss even though that
speech perception in quiet was better for DSL v5.0a. Another fitting aspect was investigated by Valente et al.
(2018). The difference in outcome between a manufacturer's first-fit and the same hearing aids with a
programmed-fit using REM to NAL-NL2 prescriptive target revealed at least 10 dB high frequency boost for
the programmed-fit with significantly higher speech score in quiet but not in noise.
Lau et al. (2014) found a support for the fitting of an extended wide band amplification as the better choice
for moderate to severe hearing aid users. Altogether, this shows that the choice of amplification and
compensation of hearing loss is also a crucial part of fitting a state-of-the-art hearing aid.
Two processing schemes that are very much responsible for providing audibility for the hearing impaired are
amplitude compression and frequency compression/transposition. Ellis et al. (2015a) found that frequency
compression provides significant benefit (above that obtained from conventional amplification) to speech
perception for many listeners with moderate-to-severe sensorineural hearing loss, at least on lab-based
outcome measures. However, this improvement may not be reflected in real-life ratings of frequency
compression. This finding was also supported by Tseng et al (2017). Ellis et al. (2015b) found that the severity
of high frequency hearing loss as well as a cognitive test was only enough to predict sentence in noise
recognition using conventional amplification as opposed to frequency compression amplification.
Plyler et al. (2013) tried two very different compression schemes found no significant differences between
the processing strategies; however, individual participants expressed strong opinions regarding their referred
signal processing strategy. All listeners where provided significant behavioral and subjective benefit,
including speech perception.
A study by Wu et al. (2019) on laboratory efficacy and real-world effectiveness of advanced featured hearing
aids relative to basic-level features hearing aids concluded that no significant difference what seen for the
satisfaction (SADL) and suggests that older adults with mild-to-moderate hearing loss are unlikely to perceive
the additional benefits provided by the premium features in their daily lives.
This indicates that, although different audibility processing schemes exist, they all have the potential to offer
an adequate fitting to the hearing impaired. Even though the effect of frequency compression/transposition
is somewhat ambiguous for the current state-of-the-art wireless hearing aids, there is a consensus that there
is at least no drawback with regards to speech perception in using this optional technology.
Regarding amplitude compression, gain and output, the largest risk of an improperly fit hearing aid is primary
related to sounds that can damage hearing and secondary to speech not made audible enough. All hearing
aids come with a set maximum power output (MPO) to protect the wearer from over amplification of loud
sounds. Furthermore, the prescription of gain and output in the fitting software is done based on an
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audiogram, and the prescription rationale will make further adjustments to the maximum power output.
Both these processes will ensure that the patient is not exposed to too loud sound.
The fact that the hearing instrument is fitted to the individual hearing loss also reduces the risk of losing vital
speech sound, since the design of fitting rationales focus on making speech audible. Even though that there
are slightly different gain prescriptions across fitting rationales, there is very little risk of jeopardizing speech
perception. As long as the presentation of speech is fairly audible there is a wide range of distributing speech
levels between the hearing threshold and the uncomfortable loudness level (Van Buuren, 1995).
In a systematic review, Chisolm et al. (2007) found that the use of a hearing aid (HA) could lead to
improvements in the perception of quality of life for adults with HI when measured with disease specific
quality of life instruments.
Recently, Hickson et al. (2014) and Convey et al. (2019) added some further knowledge to the factors of HA
satisfaction. Hickson et al. (2014) found several non-audiological factors contributing to hearing aid
satisfaction. Four self-report factors were identified as significantly influencing success: positive support from
significant others, more difficulties associated with hearing impairment in everyday life before getting
hearing aids, positive attitude to hearing aids, and higher levels of perceived self-efficacy for hearing aid
management. Self-efficacy can be defined as confidence in the ability to successfully undertake behaviors to
achieve specific goals, including improved health.
Convey et. al. (2019) elaborated more on this by reporting that persons with a better self-management of
the effects of their hearing loss on their emotional well-being and social participation were more likely to
report less aided listening difficulty in noisy and reverberant environments and greater satisfaction with the
effect of their hearing aids on their self-image. Wu et. al (2019) also found that some audiometric measures
had a statistically significant predictive effect on the total IOI-HA scores after hearing aid intervention.
Kelly-Campbell et al. (2015) also supported the notion that if HA owners have a high degree of confidence in
their ability to manage in adverse conditions (such as background noise), as well as their ability to handle and
get used to the HA, they may experience greater HA satisfaction.
Brännström et al. (2014) looked for more audiological factors as a mean to predict the limitation that
influence the HA rehabilitation efficacy. The only predictor of HA fitting outcome measured with the IOI-HA
identified was the best ear speech discrimination score, which predicted about 1/5 of the variance.
In a large-scale national cross-sectional survey with nearly 9000 hearing aid patients, on the outcome of
hearing aid provision in Switzerland, Bertoli et al. (2009) seek to support the Swiss hearing aid rehabilitation
model and justifying the higher expenses for hearing-aid fitting. They provide evidence that both usage and
satisfaction were high compared to the data from other countries.
Effort has also been put into validating the efficiency of standardized questionnaires used in other languages
for the estimation of hearing aid satisfaction. These include Chinese versions (Kam 2012; Liu et al. 2011),
German version (Meister et al. 2012) and Brazilian versions (Mondelli et al. 2011).
A line of other studies have investigated satisfaction and the contributing factors (Kozlowski et al., 2017;
Mantello et al., 2016; Faraji- Khiavi et al., 2016, Thorup et al., 2016; Kayabaşoğlu et al., 2015; Kozlowski et al,
2014; Dell’Antônia et al., 2013; Silva et al., 2013; Iwahashi et al., 2013; Aurélio et al., 2012; Laperuta et al.
2012; Hickson et al. 2010; Williams et al. 2009; Roup et al. 2009). These factors include hearing loss degree
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and configuration, hearing aid usage, hearing aid technology, perceived sound quality, interaction with
society, the ability to follow speech in different situations and the need for regular follow-ups.
Altogether, this shows not only that hearing aid outcome is a multidimensional construct, but also that
hearing aids are life-changing devices. Hearing aid technology per se, is of course is an important prerequisite
for improved quality of life, but since oral communication is so intertwined with social interaction, not only
audiological but also psychological and sociological factors are important contributors.
For real-life evaluation of hearing aid benefit, including comparative studies of different hearing aid
treatments, the Speech-Spatial-Quality (SSQ) (Gatehouse and Noble, 2004; Noble et al 2013; von Gablenz et
al, 2018; Cañete et al 2020), have received increasing clinical use. The original SSQ (Gatehouse and Noble,
2004) used 49 items for rating three subscales – Speech, Spatial and Quality, and is here referred to as
SSQ49.
Akeroyd et al (2014) investigated the properties of the original SSSQ49 for a large, diverse group of persons,
who had attended a hearing clinic, meaning a large range of hearing losses and both experienced and new
hearing aid users. 1220 persons were included in the study, allowing for generating norm data and
performing a factor analysis of the 49 scales. A factor analysis of the data showed three underlying factors
that corresponded well to the three subscales, and termed “speech understanding”, “spatial perception” and
“clarity, separation, and identification”. The analyses across the three groups were broadly similar, indicating
that it is relevant to compare SSQ results across diverse groups.
The SSQ49 is very time consuming to administer and the Akeroyd et al (2014) data set was therefore later
condensed into a 12-item questionnaire by means of a new factor analysis (Noble et al, 2013). The resulting
absolute rating variant (SSQ12) was also reformulated into a comparative (relative) variant for comparing
two hearing aid treatments (SSQ12-C). On SSQ12 ratings, very little data have been published, however,
recently Cañete et al (2020) presented results on a Spanish version of the SSQ12, which was administered for
150 adults, both normal-hearing and hearing-impaired. Significant differences were observed overall and for
the three subscales between normal and hearing-impaired groups. The authors concluded that the Spanish
SSQ12 questionnaire is a valid and reliable tool that is easy to administer and requires a short time to
answer.
Anderson et al (2018) used the SSQ49 to assess differences between hearing aid signal processing settings,
labeled ‘Mild signal processing’ and ‘strong signal processing’ on 40 hearing-impaired listeners. Here, ‘mild’
referred to slow dynamic range compression and non-linear frequency compression ‘off’, whereas ‘strong’
referred to fast compression and frequency compression ‘on’. Commercial devices were used in the study,
but the special settings were set using experimental software. The analysis showed that the SSQ49 could
indeed reveal differences between the signal processing settings within the same hearing aid type.
In a somewhat similar study, Matsumoto et al (2018) compared two variants proprietary of fitting rationales
within the same device type, namely Voice Aligned Compression (VAC) and VAC-J, which had been modified
to match the spectral properties of the Japanese language. The device used was the Oticon Alta2. In this
double-blind randomized, crossover study, the SSQ49 could not detect a statistically significant difference
between the two hearing aid settings, which could be explained by a smaller signal processing contrast than
provided in the Anderson et al (2018) study.
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5.7.2 Hearing aids for children

Three studies were found having strong evidence. The evidence covers the three focus areas of amplification,
speech perception and quality of life. For children measures of quality of life and hearing aid satisfaction
need to be assessed differently than the adult population. The advantages of appropriately fit HAs for
children will only be realized if they wear their devices on a consistent basis. The ways in which consistency
of HA use increase over time may reveal an effect of cumulative linguistic experience on speech and
language development. Walker et al. (2015) characterized long-term HA use in children, based on parent
report, and determined what factors influence consistency of HA use over time. Results indicated that the
majority of children increase HA use over time, but a substantial minority remain limited users and some
actually decrease usage over time. Family-specific variables influenced trends in long-term HA use in younger
children (i.e., maternal education level) and child-specific variables influenced trends in long-term HA use in
school-age children (i.e. degree of hearing loss). In a more recent study, Walker et al. (2020) provided
evidence for the needs for hearing aids even for children with mild hearing loss in order be on par with their
hearing peers.
McCreery et al. (2017) shows the importance of providing audibility for speech across a range of inputs and
frequencies. Children had better speech recognition outcomes than peers with HAs that were not optimally
fitted to prescriptive targets.
Frequency compression/transposition is a processing scheme that is used more and more when fitting
children with a wireless hearing aid since it, as for adults, might increase audibility for speech sounds. More
importantly for this population, the inability to hear weak high-frequency phonemes will quite likely have a
negative impact on language development. Wolfe et al. (2010) found that frequency compression for
children with moderate-to-severe hearing loss, provides significant benefit of frequency compression to the
perception of high frequency speech sounds. This was also supported in a more recent study (Wolfe et al.,
2015). However, for a more restricted population of children with near-normal hearing thresholds in low and
high frequencies, John et al. (2014) did not show either improvement or degrading speech perception
compared to conventional full bandwidth amplification. This was also supported by Kirby et al. (2017) who
found similar speech recognition ability and listening effort using high-frequency speech sounds, between
conventional processing and frequency composition.
A limitation of the literature evaluation presented above, is that the satisfaction tool is self-reported. This
would limit the amount of toddlers and young children. A far better evaluation choice is based on the child's
caregiver report on the child's auditory behaviors using a questionnaire. Based on a critical review (Bagatto
2011; not part of literature search), two questionnaires have been recommended: the LittlEARS Auditory
Questionnaire and the Parents' Evaluation of Aural/Oral Performance of Children (PEACH). The items in the
LittlEARS are more appropriate for young and the PEACH items describe more complex scenarios that are
suitable for younger children.
During the process of validating the UWO PedAMP protocol, several hundred children have been enrolled in
the studies. Results from two such large scales studies (Bagatto, et al. 2016; Bagatto, et al. 2011) have shown
that typically, developing from birth to 9 years of age, are meeting auditory development milestones during
the early stages of hearing aid use (i.e., LittlEARS) and displaying typical auditory performance as they get
older (i.e., PEACH). This is valid for a variety of different state-of-the-art hearing aid from the last decade.
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When it comes to the effect of hearing aid habilitation on speech and language development there are
studies in this literature search with strong evidence. In a study by Walker (2015) showed that full-time HA
users (5 to 7 years old) demonstrated significantly higher scores on vocabulary and grammar measures
compared with nonusers. After controlling for the variance in age at confirmation of HL, level of audibility,
and enrollment in early intervention, only amount of daily HA use was a significant predictor of grammar and
vocabulary.
Tomblin et al. (2015) investigated even younger children (3 and 5 years old) and found that the degree of
improved hearing provided by HAs was associated with better speech and language development in children.
In addition, the duration of HA experience interacted with the aided hearing to influence outcomes. A recent
follow-up study, Tomblin et al. (2020) found that children with moderately-severe losses were less skilled in
language and reading than the normal hearing children and children with mild and moderate losses.
However, audibility provided by hearing aids was found to moderate the effects of HL with respect to these
outcomes.
A study by Kiese-Himmel (2008) demonstrated and confirmed earlier research, i.e. the relationship between
hearing-impaired children’s receptive vocabulary and their severity of hearing impairment, and their age of
hearing impairment diagnosis. These results provide support for early HA fitting and HA provision to children
with hearing loss as well as evidence that children’s language development benefits from consistent HA use.
Besides focus on general outcomes in children, some studies on very specific topics has also been included in
the search. The two topics are prescription of gain and the use of frequency compression processing. Ching
et al. (2013) tested two different generic prescriptions used would wide, NAL-NL1 and DSL i/o. They found in
a large group of 3 years old children, no significant differences in children’s language, speech production, or
functional performance (using PEACH) between prescriptions. What they found instead was that socio-
economic status and maternal education were found to be significantly associated with language and
functional performance.
As mentioned in the adult section above, frequency compression is one of the recent advantages in signal
processing in hearing aids. Two studies of strong evidence both conclude that frequency compression in
toddlers and young children do not contain either benefit or any side effect (Ching et al. 2013; Bentler et al.
2014). Both studies conclude that there is insufficient evidence to indicate a difference in language ability
between children using frequency compression and those using conventional amplification.
All in all, based on the cited literature above, the first couple of years is a vital period of development for a
child with hearing loss. Early intervention of hearing loss will lessening the overall impact a hearing loss can
have on the child’s development. Untreated hearing loss could potentially lead to not reaching normal
milestones before time of school. Another consequence could be a language deficit that adversely can affect
a child's vocabulary, sentence structure, and speaking ability, causing learning problems. Inadequate
language skills can also affect communication with peers, leading to feelings of social isolation.
5.7.3 Unilateral fitting

When it comes to fitting of unilateral hearing loss, there is only limited literature about hearing aid fitting for
these patients. By means of the IOI-HA self-assessment questionnaire (José et al. 2011) reported on the
satisfaction of individuals with unilateral hearing aids and hearing loss. When asked about satisfaction
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concerning the use of the hearing aids, 60% of the individuals reported that it is really worth using them and
40% reported that it is reasonably worth using them unilaterally.
Unilateral fittings of bilateral hearing loss are more documented in the literature. Brännström and
Wennerström (2010) did a descriptive and correlational study in a retrospective sample. They found no
significant difference in IOI-HA scores for subjects wearing one or two hearing aids. Average satisfaction
score for both groups exceeds four units (out of five). Their result was also supported Cox et al. (2011),
Bertoli et al (2010) and Boymans et al. (2009). Boymans et al. (2009) found a small satisfaction effect in favor
of bilateral fitting but did not believe it was sufficient enough to be clinically significant. Recently Kwak et al.
(2018) demonstrate the benefits of hearing aids on speech perception in noise, in addition to their
amplification effect, but only when hearing aids restores symmetric hearing, i.e. bilateral users and unilateral
users in the worse ear.
In summary, there seems to be support for both types of unilateral fitting schemes. In groups matched on
gender, age, degree of hearing loss, and audiometric asymmetry it is difficult to show a significant difference
between unilaterally fitted and bilaterally fitted persons for hearing aid satisfaction.
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Performance and safety data retrieved from the literature - Tinnitus
67A systematic literature search was performed to identify relevant published articles to assess whether the
available body of clinical evidence supports the use of sound therapy support. The selection strategy
comprised two selection phases: During the first selection (abstract screening) four different criteria
wereapplied: population, device, review/surveys and language. In case the abstract information was not
enough, the specific information was collected through the full-text of the publication.
The second selection was done after a light review of the full-text of the publication. At first, to exclude
publications without commercial hearing aids. Letters to the editors, forwards, as well as review articles were
also excluded since they do not contain new data. Furthermore, laboratory studies, only using the device for a
few hours were excluded as well as studies using unspecified devices with a scope of investigating audiological
service and processes.
Using the significant keywords, “Tinnitus and treatment” as well as “masking and retraining therapy” to
include some of the larger tinnitus paradigms and finally combination instrument” to rule out research using
only sound generators with normal hearing patients. A total of 359 publications were retrieved in the search
process. This first part of the literature search was performed according to the inclusion and exclusion
criteria described in the Clinical Evaluation Plan. In summary, 249 publications did not meet the inclusion
criteria and were excluded after the abstract review. 113 publications deemed to be within the acceptance
criteria were obtained and read. 239 publications were deemed to be outside of acceptance criteria after
reviewing the complete publication. The remaining 10 publications were appraised and analyzed in the
following.
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Figure 16. Overview of literature search results for Tinnitus sound therapy
Result of search:
Not included
161/75/123
Wrong population: 16/10/23
Wrong device type:
54/19/12
Review Review/survey: 24/21/26
Prevalence study: 1/0/0
Not in English: 17/8/14
Remaining after abstract review :

49/17/47
Not included
Review No commercial dev: 2/0/0
Audiological service: 1/3/1
Laboratory/diagnostic
study: 41/11/41
Wrong outcome 1/1/0/
Remaining after full text review: 4/2/4 Doublet: 0/0/1
Clinical data relevant to

Clinical data relevant to
safety and performance
safety and performance
for a specific state-of-art
for an unspecified state-of-
hearing aid with sound
art hearing aid with sound
therapy support with
therapy support with
regard to the performance
regard to the performance
variables tinnitus relief
variables tinnitus relief and
and sound quality of
sound quality of masking:
masking sound:
2/0/2
2/2/2
The search has been divided into three searches (A1, A2 and A3) and is separated in the figure with a forward slash “/”.
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5.8.1 Tinnitus relief with combination instrument
As mentioned earlier, combination instruments merge state-of-the-art HAs with an acoustic signal that may
be broadband, band shapeable, amplitude adjustable, amplitude and frequency modulated, and/or fractal
(Henry et al, 2015). The increased distribution of records during the last couple of years reflects the
introduction into clinical practice and recent increased use of combination hearing aids as a management
option, a trend likely related to the improved quality of amplification provided by the instruments (Titaj et al.
2017).
Four studies were found having compelling or strong evidence and will be emphasized in the following
discussion. The evidence covers the focus areas of relief of tinnitus.
The study of dos Santos et al (2014), one of the first studies addressing this question, who evaluated 49
patients using a blind randomized clinical trial. One patient group received a hearing aid combined with
tinnitus relief sounds and a reference group received amplification alone. Both groups experienced a
significant reduction in tinnitus annoyance as assessed using the THI. The difference between groups,
however, was not statistically significant. Henry et al (2017) found a clinically significant improvement in
reaction to tinnitus for a majority of participants in their three intervention groups: receiver-in-the-ear
hearing aids, the same hearing aids with a sound generator, and a custom-made deep fit hearing aids. The
difference between groups, however, was not statistically using the TFI.
In a study by Henry et al. (2015) participants were assigned to either an experimental group (combination
instrument with tinnitus sound enabled) and a control group (combination instrument with tinnitus sound
disabled). Both groups revealed significant improvement, as indicated by reductions in mean TFI index
scores. Differences between groups at 3 months were not statistically significant. Results suggest that the
use of hearing aids alone or hearing aids plus the use of sound generators both provide significant benefit
with respect to alleviating effects of tinnitus.
Bauer et al (2017) found significant improvement in tinnitus impact occurred after both TRT and a control
group with standard care therapy, with a larger treatment effect obtained in the TRT group. Lasting
therapeutic benefit was evident at 18 months in both groups. Both treatment groups received acoustic
enrichment through the use of binaural combination hearing aids, and both received counseling, albeit not
identical counseling.
A strength of the Bauer et al (2017) lies in the enrollment in the treatment arms of RCT that was balanced for
variables that might be expected to impact treatment (e.g., severity of tinnitus, gender).
Two studies showed a fair evidence in this area as well. Henry et al. (2016) made a multisite RCT evaluating
TRT and TM with mostly combination instruments found that TRT (and TM) reduced tinnitus severity over a
period of 18 months. The attention-control group, only received amplification, was significantly better than a
waiting list control group but not significantly different from the treatment groups TRT and TM. Even though
this study was design wise quite ambitious (multisite and RCT) the treatments was not completely balanced
and homogeneous with regard to both treatment (combination instrument) and control group
(amplification) it was still dominating both groups.
Barozzi et al. (2017) evaluated the effect of the sound generators power spectrum of a combination
instrument in order to increase the effectiveness and acceptability of the tinnitus. The sound generator of a
combination instrument usually offers more flexibility than a conventional white noise generator. They found
a significant reduction in tinnitus handicap in both groups following 3 and 6 months after fitting using THI.
However, no significant difference was found between the two groups using one or the other type of sound.
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Sweetow and Sabes (2010) tested a group of hearing impaired where ten out of 14 were unaided listeners.
They observed their tinnitus annoyance over a period of 6 months when using a combination instrument
with different fractal sounds. They found significant reduction in both THI and TRQ score after 6 months of
therapy. Since most of the group did not wear hearing aid prior to the fitting, it cannot be determined if the
less reactivity with regard to their tinnitus is due to amplification or the use of fractal sound therapy.
Korres et al (2010) used a tinnitus group with 88% hearing impaired who received a combination instrument.
They conclude that at a follow-up one year after initial treatment, the reduced level of annoyance induced by
tinnitus was still valid with regard to the patients rated ability to work, sleep, relax or be concentrated.
However, the authors assign the effect of the reduction to the TRT protocol and not to the amplification per
se.
In an attempt to evaluate the physical aspects and noise options on the experimental device rather than to
evaluate the sound therapy in itself, Sereda et el. (2017) found that Individual preferences for the different
masking program options varied widely, both across participants and across listening situations. Even though
the study was designed as a pilot study with low statistical power, they found the sound of the ocean often
did not mask tinnitus as the other therapeutic sounds, but rather provided distraction and/or aided
relaxation. A concluding remark regarding the use of nature sounds, points to adequate counselling of
patients about the rationale behind the sound therapy and role of different types of sound in providing relief
from tinnitus.
The results of Henry et al (2015, 2016, 2017), dos Santos (2014), Barozzi et al (2017), Bauer et al. (2017),
Sweetow and Sables (2010) and Korres et al. (2010) are consistent with the preponderance of studies that
have investigated the use of combination hearing aids for tinnitus management (Tutaj et al. 2017).
Although these studies used combination instruments from different manufacturers, their results show the
same general trend. In all the studies, the use of the combination instruments resulted in significant
improvement in the primary tinnitus outcome measure.
It is worth remembering that any therapeutic approach using sound therapy has an optimized effect when
associated with counseling (Jastreboff, 1990; Tyler, 2006), which helps break the vicious cycle of stress
caused by tinnitus, helping the patients to change their behavior and way of thinking (Tyler, 2006). In the
above-mentioned papers, all points toward a conclusion that combination instrument provide relief of
tinnitus. This is an encouraging result given that they combine multiple approaches to manage tinnitus. Two
important components in the different approaches are the management program and the sound type. The
dominant therapy protocol used in the clinical are TRT. One of the main differences between management
programs related to the level of the noise used in the tinnitus therapy. TM aims to provide immediate relief
from tinnitus, achieved by complete masking if possible without setting the masking sound to an
uncomfortable level (Henry et al. 2006), other approaches such as TRT and Zen Therapy recommended
setting the noise at mixing point or below the level of tinnitus, arguing that habituation was not possible
when tinnitus is completely masked or the perception is markedly changed (Jastreboff & Jastreboff 2000).
However, based on the mentioned literature it is not clear whether one management approach produced
better outcomes than another. Of all eight retrieved tinnitus relief studies there was a mix of different
protocols: three were TRT, two were PTM, one was Zen, one was both TRT and TM and one was a mix of TM
and TRT protocols. This indicates, that all three approaches provide some degree of relief. This was also
concluded in a study by Tyler et al. (2012), were they showed that TRT and TM were equally effective for the
habituation of tinnitus.
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With Notch Therapy, the notched frequency response provides a therapeutic effect by spectrally modifying
the acoustic signal while integrating seamlessly into the wearer’s personal amplification. In an attempt to
apply notch therapy, Rocha and Mondelli (2018) monitored ear canal levels by means of real-ear
measurements. in a group of 40 tinnitus patients. Unfortunately, the paper is poorly written and it is not
possible to deduce how the fitting was performed. Nevertheless, since treatment consisted of a combination
of a first fit with a hearing aid and sound generator, it remain unknown whether the significant reduction in
THI was due to hearing aid treatment, tinnitus relief sounds or both.
When it comes to the preference to sound type there is a lack of studies investigating the more
individualized sound therapy approach with combination instruments. Sereda et al. (2017) concluded that
the availability of different sounds in the same combination instrument could play a role in the everyday life
of the user, from a more masking paradigm towards distraction and/or aided relaxation.
In summary, it is evident that there exists a clinical benefit of sound therapy support, by obtaining relief from
tinnitus of the patient. Furthermore, it has been evident clinically as well as scientifically for quite some time,
that the clinical benefit exceeds the risk of harm due to noise exposure from the sound therapy support
(McFadden, 1982; Hazell et al., 1985; Tyler & Bentler, 1987).
5.8.1.1 Sum up
No safety issues or complaints were found in the nine refereed papers for adults for wireless hearing aids
with sound therapy support, why it must be concluded, that they are safe to use. With regards to
effectiveness, the data from the included studies show strong evidence of the efficacy of sound therapy using
combination instruments in tinnitus management.
6 Appraisal of pertinent data
The data collection and appraisal are described in the Data Collection Report in Appendices H, and I. The data
sets included 74 journal articles retrieved from the scientific literature reporting clinical data from adults (46
articles) and children (18 articles) as well as for tinnitus (10 articles). a clinical studie involving 21 patients
conducted by the manufacturer demonstrating device claims and clinical benefit from using the device under
evaluation Oticon More 1. Additionally, two studies involving 22 patients conducted by the manufacturer
demonstrating device claims and clinical benefit for tinnitus. Data from usability studies (with 30 subjects)
and post-market surveillance are also presented.
Searching in clinical trial database https://clinicaltrials.gov/ (not reported elsewhere) for hearing aids models
Oticon Ruby and Oticon Opn S 1, did not find any ongoing or planned studies with the equivalent devices,
including investigators’ initiated studies.
Data retrieved from medical devices vigilance databases in Europe, North America and Australia have
indicated that the Oticon wireless hearing aids are safe for the intended use. No recalls or field safety notices
concerning the devices were reported to the FDA MAUDE, Health Canada, Australian TGA, nor to major
competent authorities in Europe, including MHRA and BfArM.
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The wireless hearing aids covered by this Clinical Evaluation Report are intended for children and adults.
Since our own data on clinical benefit for children are limited, a PMCF process has been initialized in order to
investigates the safety and clinical performance of all pediatric products released to the market.
7 Analysis of the clinical data
The purpose of this analysis was to determine if the summarized and appraised data sets available for
wireless hearing aids collectively demonstrate compliance of this device type with the General Safety and
Performance Requirements of the MDR pertaining to the clinical safety and performance of the devices
when used according to its intended purpose.
Safety
With adherence to applicable standards, qualitative and quantitative aspects relating to safety of the device
under evaluation, More 1, have been examined to show if the device is safe to use for the intended purpose
and indication. Methods comprise risk assessment including mitigations, searches in complaints, adverse
event/safety and literature databases, as well as assessment of own pre-clinical and clinical data. A general
focus on safety as well as a specific focus on known residual risks have guided the activities.
In order to assess and substantiate compliance with the requirement on safety, the QMS procedures for Risk
Management (DOC-0065 SOP – Risk Management), Usability Engineering Process (DOC-0309 SOP), Post-
market surveillance (DOC-0526), Complaint Handling (DOC-0124), Post-market Clinical Follow-up (DOC-
0553), Design Verification (DOC-0050 SOP – Design Verification), Design Validation (DOC-0051 SOP) and
Clinical Evaluation (DOC-0519 SOP Clinical Evaluation) have been followed.
Risk Assessment
The risk analyses are used to identify potential failure modes (risks) of the actual device under evaluation, i.e.
More 1 miniRITE R. The risk analyses in conjunction with conclusions drawn from the evaluation of pertinent
technical characteristics, and literature review is used to demonstrate compliance with the EN ISO 14971 –
Application of Risk Management to Medical Devices.
For the Oticon More product several hazards have been identified.
For all identified risks, an acceptable risk level has been achieved after risk control measures are
implemented, and necessary warnings have been identified and addressed.
In the risk assessment, Risk Assessment for - Hearing Instruments and Tinnitus Maskers - Polaris 20.2, Doc No
0901c76e8098bbe7, rev.3.0, the following risks with significant severity are listed:
Table 46: Hazards with significant severity
ID* Hazardous Situation Probability of Conclusion of
occurrence of individual
Risk Control Measure
harm risk/benefit
analysis
HR_P234_57 Li-ion battery 1. Device and its components Improbable Residual risk is
swallowed, lodged in must be designed to be robust deemed
Hazard_331 throath/esophagus or towards mechanical impacts and acceptable
placed in the nose or drops during transportation,
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ears. When the storage and daily use. (ref.

battery is exposed to 60601-2-66)
body fluids, it can
create an electrolysis 2. Device must be designed to
reaction leading to a ensure that the battery is not
current from the accessible by the end user.
battery generating
hydroxide. 3. As the device cannot be
Worst case, this can designed to keep children out of
lead to death in less reach of it, instructions for use
than two hours due to must:
higher voltage than 3.1. Warn the end user about
other battery what can occur if Li-Ion battery
technologies (death is swallowed
only seen with Li-ion 3.2.Warn the end user of
batteries of sizes 20 keeping the device out of reach
mm and above). of children
3.3. Warn the end user of not
attempting to open the battery
compartment or replace the
battery
3.4. Instruct the end user in what
to do in case of a swallowed
battery.
HR_P234_59 Parts (not battery) Note: Hearing instrument has to Improbable Residual risk is
lodged in throat after be small enough to be worn in or deemed
Hazard_333 ingestion behind ear. Therefore the device acceptable
Hazards related to cannot be designed in a size big
swallowing batteries enough to avoid swallowing.
are adressed in
hazard #Hazard_331 1. Device and its components
(Li-Ion battery) must be designed to be robust
towards mechanical impacts and
drops during transportation,
storage and daily use (ref.
60601-2-66)
[Device intended for adults and

children above 36 months]:
2. All detachable parts that are
inserted in the ear must
withstand a pull force of 3 N (ref.
60601-2-66)
3. Instructions for use must:

3.1. Warn the end user of
keeping the device out of reach
of children
3.2 Warn the end user against
modification of the hearing
instrument
HR_P234_60 End user exposed to 1. Device and supplied Improbable Residual risk is
high voltage accessories must be designed to deemed
Hazard_334 comply with relevant electrical acceptable
safety standards.
2. When the device is developed

to be connected to electrical
equipment manufactured within
WDH (charger), the "electrical
system" must be safe.
3. Instructions for use must warn

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the end user of ensuring that

any external high power
equipment to be connected to
the HI must comply with
electrical safety standards.
HR_P234_61 End user exposed to 1. Device and its components Improbable Residual risk is
flames must be designed to be robust deemed
Hazard_335 towards mechanical impacts and acceptable
drops during transportation,
storage and daily use (ref.
60601-2-66)
2. Li-Ion battery must be

designed to be in compliance
with relevant safety standards.
3. The high-power equipment

must be designed to be in
compliance with relevant safety
standards (charger).

4.1. Warn the end user about
use in explosive environments
HR_P234_82 Body worn/portable 1. All underlying ES and FW Improbable Residual risk is
device affecting life- items must be designed, deemed
Hazard_337 supporting medical reviewed and tested in acceptable
devices (e.g. accordance with the QMS
pacemaker) in the system.
surrounding
environment 2. Electronic devices must be
designed to comply with all
relevant standards on EMC
emission
3. Device must be designed with

hang or runaway detection
4. Device must be reset if hang

or runaway code is detected

- Warn user about using HI's
with Active implants and if
applicable, about tools with
build-in magnets (e.g. Multi-tool)
- Warn user about bluetooth and
use on air-craft
- Warn user about incompatible
non supplied accessories
HR_P234_55 End user body 1. Device and associated Improbable Residual risk is
exposure to: accessories must be designed to deemed
Hazard_339 a) carcinogenic, use biocompatible materials in acceptable
mutagenic or accordance with requirements
reprotoxic substances from relevant standard(s) and
(CMR) avoid materials which contains
b) Phthalates high concern substances
2. Supplier quality must be

controlled
3. Instructions for use must warn
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about exposing hearing

instrument to heat and
chemicals
HR_P234_99 Li-ion Battery is 1. Device shall be designed to Improbable Residual risk is
charged at a too high provide current-limiting and deemed
Hazard_388 voltage or current and voltage-limiting protections for acceptable
ignite the battery: Protection Circuit
Module [PCM], in case of failure
of the Charge Control Circuit
[CCC].
HR_P234_102 Destruction of the A. When Lithium ion batteries in Improbable Residual risk is
transportation medium equipment are shipped, all deemed
Hazard_391 / storage area that possibilities of a short-circuit or acceptable
can cause fatalities. activation shall be eliminated.
When Li-ion batteries are bulk
shipped, we shall ensure that no
batteries can come in contact
with other batteries, conductive
surfaces or metal objects while
in transport.
Conditions of transportation
meet requirements of applicable
standards:
IATA, ICAO - Packing Instruction
965-967
IMDG code 3.3 - SP 188
RID SP 188
ADR SP 188
DOT 49 CFR Section 173.185
B . Li-ion battery shall comply

with applicable standards: UL
1642, ed. 1 2012, IEC 62133-2,
ed. 1 2017 and UN 38.3, ed. 6
HR_P234_103 Exposure to 1. Battery is designed to prevent Improbable Residual risk is
excessive heat that corrosion. deemed
Hazard_392 can cause burns. acceptable
2. Battery must be safe by
design.
3. IFU shall instruct users how to

store hearing instruments with
Li-ion battery when not in use.
HR_P234_104 Exposure to 1. Battery is designed to prevent Improbable Residual risk is
excessive heat that corrosion. deemed
Hazard_393 can cause burns. acceptable
2. Battery must be safe by
design.
3. Requirement for the

manufacturer of batteries: it shall
make sure that the risk of
corrosion is correctly addressed
all along the
manufacturing/packaging
process (PFMEA).
4. HCP shall be instructed on

how to handle safely the Li-ion
batteries
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HR_P234_119 User distracted by Instruction for use must warn the Improbable Residual risk is
device in a situation user about the risk of being deemed
Hazard_477 where full distracted in a situation that acceptable
concentration is requires full attention (e.g.
required driving a car)
* Product Specific Hazard ID and Hazard Repository ID from the Demant Hearing Instrument Group’s requirement
database DOORS.
In the risk assessment, Risk Assessment for - Hearing Instruments and Tinnitus Maskers- Polaris 20.2, Doc No
0901c76e8098bbe7, rev. 3.0, the following risks with moderate severity are listed:
Table 47: Hazards with moderate severity

ID* Hazardous Situation Probability of Conclusion of
occurrence of individual
Risk Control Measure
harm risk/benefit
analysis
HR_P234_83 Body worn/portable 1. All underlying ES and FW Improbable Residual risk is
device affecting non items must be designed, deemed
Hazard_338 life-supporting reviewed and tested in acceptable
medical devices (e.g. accordance with the QMS
deep brain stimulator) system.
in the surrounding
environment 2. Electronic devices must be
designed to comply with all
relevant standards on EMC
emission
3. Device must be designed with

hang or runaway detection
4. Device must be reset if hang

or runaway code is detected

- Warn user about using HI's
with Active implants and if
applicable, about tools with
build-in magnets (e.g. Multi-tool)
- Warn user about bluetooth and
use on air-craft
- Warn user about incompatible
non supplied accessories
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HR_P234_88 Person not requiring 1. All underlying ES and FW Improbable Residual risk is
hearing aids or user items must be designed, deemed
Hazard_340 with a hearing loss reviewed and tested in acceptable
not requiring an MPO accordance with the QMS
> 132 dB SPL system.
exposed to harmful
sound pressure level 2.
(>132 dB SPL) 2.1 The hearing instrument must
be designed to ensure that client
MPO is always lower than
technical MPO to ensure that
the client will not be able to
reach higher sound pressure
levels that required by the
hearing loss. Input from external
sound sources must never
exceed client MPO.
2.2 Device must be designed
with a redundant MPO system
(safety MPO)
3. Device must be fitted with a

default production setting to
ensure that the device does not
deliver maximum possible
output (MPO) before the device
is fitted to the specific user
audiogram.
4. A dedicated attribute in the HI

must be marked if the current
settings are technical settings.
After technical setting dialog
procedure and during connect
fSW must verify if the current
settings are technical settings
and if so fSW must restore
current settings, e.g. prescribed
settings.
5. fSW must indicate that the

chosen instruments do not
match the previous fitting
session ("Alien fit").
6. During in-situ fine tuning:

6.1. The fSW must display a
warning when in-situ is used
without a prescribed audiogram.
6.2. The Instructions for use
must inform the HCP that in-situ
is a tool used for fine tuning
7. The HCP is a trained

professional, who understands
the different acoustical
options/parts. Furthermore,
hearing instruments and their
parts are designed to fit only one
of the user's ears (moulds,
speaker unit wires, etc.) which in
itself mitigates that the end user
will experience the hazard. The
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following risk control measures

must be in place:
7.1. Device must be designed
with clear color marking on
product itself, on receiver units,
in product pictures and in
receiver selection list in fSW.
7.2. The fitting software must
display a warning during fitting
of all hearing aids with a
possible MPO > 132 dB SPL to
inform the HCP to be careful
when fitting hearing aids with
MPO > 132 dB SPL.
7.3 The instructions for use must
inform the user of color
indications marking the
difference between left and right
HI
8. The fSW must ensure that the

HCP takes all necessary steps
when using the REM autofit
feature, including not being able
to proceed if the probe is not
calibrated
9. During eSW upgrade the HI

must be muted.
Additionally, the fSW must warn
the HCP about:
9.1 that the HI will return to
factory settings after upgrade
9.2 removing the HI from the
enduser's ear
10. Device cannot be designed

to mitigate improper use by non-
hearing impaired person.
Labeling must warn about this
risk:
- others using hearing
instruments and
- that instrument is a power
instrument
11. The following risk control

measures must be in place
related to cybersecurity:
11.1 Upgrade fitting sessions to
use BLE 4.2 secure connections
11.2 Implement proper secure
PRNG as according to
standards Harvest entropy from
microphones
11.3 Pairing window is only
restarted after power on
See also Cybersecurity Risk
Assessment #1, #3, #5, #6, #7,
#13 and #14
[Wireless fitting]:
12. For the connected HI, the FS
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platform shall display the

information about its side.
[Wired fitting]:
13. The HI must be designed to
ensure that exchanging the HI
during fitting will result in an
error.
14. Receiver and micropphone

calibration must not exceed +/-
3dB and must be enforced by
the HI
HR_P234_89 User with a hearing 1. Device must be designed to High The harm is a
loss requiring an not provide harmful sound consequence of
Hazard_342 MPO > 132 dB SPL pressure levels unless strictly normal intended
exposed to harmful necessary for the user (ref. use. The clinical
sound pressure level 60601-2-66). benefit for the
(>132 dB SPL) user, to be able
Note: to hear at all,
It is within the intended use that exceeds,
the device can provide sound however, the
pressure levels that are harmful. risk of harm
This hazard can therefore be
expected several times during
the lifetime of the device.
HR_P234_71 Device or part stuck 1. Device must be designed with Improbable Residual risk is
in ear after hearing a pull force of minimum 3 N for deemed
Hazard_344 aid removal. all detachable parts that are acceptable
inserted in the ear
2. Instructions in attaching
domes, moulds, etc. correctly
must be included in the
instructions for use, on
detachable part packaging and
on website
3. Instructions for use must

contain a warning about what to
do in case of missing earpiece
on tube when removing the HI
from the ear
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HR_P234_86 User experiencing 1. Improbable Residual risk is

prolonged exposure Audiometers used to measure deemed
Hazard_370 to sound pressure audiograms are not produced acceptable
levels higher than within Demant HIG and are as
required by the actual such outside the control of
hearing loss. Demant HIG. The audiogram
measured using an audiometer
is directly transferred to the
fitting software and is used to fit
the hearing instruments.
The HCP will conduct a fine

tuning of the sound output at the
various frequencies to account
for the end user's specific sound
perception. As the HCP is a
trained professional, such
adjustments are a part of the
HCP's daily work to ensure end
user satisfaction and safety.
For smaller children which are

not able to give the same type of
feedback as adults, the HCP
uses the Pediatric Fitting Mode
in the fitting software, which is
specifically aimed at guiding the
HCP towards to the most correct
fitting. Furthermore, the
Pediatric Fitting Mode applies
best practices for fitting children
to ensure a correct sound
output.Finally, the HCP as a
professional is trained in
applying a different approch with
children.
Furthermore, as hearing
instruments do not emit sound
continually, this hazard cannot
be compared to "normal" noise-
induced hearing losses, which
are typically experienced in
working environments with
continual exposure of high
sound levels.
This means that for normal
hearing instrument users, the
harm of trivial/minor injury to
residual hearing will occur only
in extremely few cases after
several years of wearing hearing
instruments with
overamplification.
[Related to exceeding fitted

OSPL90 and Acoustic energy
(i.e. infra- and ultrasound) and
vibration]:
2. HEARING AIDS shall be
designed in a way that users
cannot be unintentionally
exposed to a SPL above the
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FITTED OSPL90 in NORMAL

CONDITION.
2.1 A dedicated attribute in the
HI must be marked if the current
settings are technical settings.
After technical setting dialog
procedure and during connect
fSW must verify if the current
settings are technical settings
and if so fSW must restore
current settings, e.g. prescribed
settings.
2.2 fSW must indicate that the
chosen instruments do not
match the previous fitting
session ("Alien fit").
with clear color marking on
product itself, on receiver units,
in product pictures and in
receiver selection list in fSW.
2.4 The HCP is a trained
professional, who understands
the different acoustical
options/parts.
2.5 Hearing instruments and
their parts are designed to fit
only one of the user's ears
(moulds, speaker unit wires,
etc.) which in itself mitigates that
the end user will experience the
hazard. Additionally, the
instructions for use must inform
the user of color indications
marking the difference between
left and right HI
2.6 The hearing instrument must
be designed to ensure that client
MPO is always lower than
technical MPO to ensure that
the client will not be able to
reach higher sound pressure
levels that required by the
hearing loss. Input from external
sound sources must never
exceed client MPO.
with a redundant MPO system
(safety MPO)
with a check sum validation for
data and code loaded from
NVRAM.
2.9 The device must reboot if
invalid data or code is
encountered.
2.10
In normal conditions the hearing
instrument must be designed to
deliver a supply voltage of 1.25V
and the supply voltage must be
limited to be between 0.86V and
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1.65V
See MoM for more information:
0901c76e809b9a0b, topic 1
2.11
Supplier must comply to
maximum tolerances specified
by IEC 60118-7
The acceptable level increase in

SINGLE FAULT CONDITION is
evaluated in the column "Further
Risk Control Measure?".
3. The FITTED OSPL90 shall be

indicated on either the
HEARING AID or the fitting
software or otherwise. See the
column "Further Risk Control
Measure?" for evaluation of
deviation.
HR_P234_90 User exposed to Device cannot be designed to Improbable Residual risk is
Tinnitus avoid misuse by non-hearing deemed
Hazard_372 SoundSupport longer impared persons. However, acceptable
than defined in the prolonged exposure to high
max wearing time noise is very unpleasant and
indicator thus very unlikely to occur.
1. All underlying ES and FW

items must be designed,
reviewed and tested in
accordance with the QMS
system.
2.
2.1 fSW must be designed to not
be able to set the maximum
power output of the Tinnitus
SoundSupport in the HI higher
than 90 dB SPL
2.2 Tinnitus SoundSupport must
be designed to ensure that the
generation of sound pressure
levels does not exceed 90 dB
SPL.
not be able to exceed the
maximum sound pressure level
set by the HCP
be inserted in the signal chain
before the client MPO and
safety MPO
3.
3.1 The system shall provide
information to the HCP and end
user about maximal safe
wearing time per day
3.2 fSW must be designed to
provide data about maximum
wearing time per day in the
print-out report
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4. fSW must inform/warn the

HCP about:
4.1. The risk of high sound
pressure level produced by the
Tinnitus SoundSupport in the HI
when the sound pressure level
is 80 dB SPL or above
4.2. Limitations in wearing time
4.3. The intended user group of
the Tinnitus SoundSupport (user
must be minimum 18 yrs)
4.4. That mandatory counseling
of end user in the maximum
wearing time of Tinnitus
SoundSupport can be found in
the fSW
4.5. That the maximum wearing
time must be documented in the
instructions for use
5. Instructions for use must

include a warning about using
the Tinnitus SoundSupport
longer than defined by the
Maximum Wearing Time
Indicator.
* Product Specific Hazard ID and Hazard Repository ID from the Demant Hearing Instrument Group’s requirement
database DOORS.
Each of these different hazards has been addressed and mitigating risk requirements have been
implemented according to DOC-0065 SOP – Risk Management, and after implementation, all risks have been
reduced to acceptable level, i.e. the overall benefit outweighs the overall residual risk, documented in Risk
Management Report for Oticon More.
Smaller parts
Specifically, regarding hazards related directly to intended users’ (adults and children from 3y) handling of
the hearing aid, the risk for children swallowing the battery should be highlighted.
Small parts like batteries can be swallowed, but the Magneto hardware with rechargeable battery has a
battery drawer that can only be opened by the HCP using a special tool.
Maximum power output

Specifically, regarding hazards related directly to the intended purpose and use (treatment of people
suffering from a hearing disability, by amplifying and transmitting sound to the ear), the aspects concerning
the MPO and sound pressure level in the ear >132 dB SPL should be emphasized.
The risk of being exposed to too loud sound (>132 dB SPL) that might worsen the hearing is mitigated in the
following way: Gain is prescribed to the individual hearing loss by the fitting SW. The fitting SW will not cause
the HA to produce sound levels exceeding prescribed MPO (Client MPO). The client MPO is limited by
Technical MPO in the hearing aid.
In addition, recent studies (Johnson, 2017; McCreery et al. 2016) have shown that the established evidence
based prescriptive fitting rationales used in the fitting software further ensure safety in regard to the risk of
increasing hearing loss through high gain for loud input levels applied by the hearing aid. Both studies
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conclude that the output level of the hearing aid for 80 dB SPL input levels prescribed by the fitting rationales
does not exceed the safe output SPL that marks the risk of introducing a permanent threshold shift (PTS).
Usability studies
As part of the usability engineering process before placing the device on the market, the IFU including
warnings, was concluded to fulfil the requirements, and the hearing aid was safe and easy to use [U2]. See
3.4 for references to standards and guidance.
Complaints and adverse events

A very low percentage of customer complaints in relation to sales was seen, and with 0% complaints
identified with high level output of the device and 0% vigilance cases identified. Across complaints and
adverse events no safety issues were reported for the devices equivalent to the device under evaluation,
More 1, which indicates a very low risk and supports safe use for More 1. Considering that this technology
has been on the market for many years and offered by a large number of manufacturers, it becomes clear
that there is no outstanding risk relating to the use of wireless hearing aids to take into consideration.
Device performance related to safety – Hearing aid

To demonstrate that existing data (V2) meets this requirement, the following steps are taken:
1. More 1 is fitted on each subject tested using their individual hearing loss. The average hearing loss for the
speech important frequencies, 0.5,1, 2 and 4 kHz, was for the group of subjects 47.7 dB HL (SD 15.6 dB HL)
for the right ear and 48.3 dB HL (SD 15.3 dB HL) for the left ear.
properties of the ear. The prescription is expressed in insertion gain. The mean value for REIG is for both ears
16 dB with a range from 7 dB to 24 dB
3. Since the selected speaker level for the validation test, depending on the hearing loss of the subject, was
both 60, 85 or 105, the maximum power output has the potential to exceed the limit of 132 dB SPL. The
maximum power output has not been verified directly on the subject but has instead very accurately been
simulated in the fitting software (in-situ output).
4. ). By using a pure tone signal at 90 dB SPL, it has been shown that the maximum power output (MPO) does
not exceed 132 dB SPL. For all three kinds of speaker levels and all hearing losses used in this study, the
requirements on safety using existing clinical data has been met.
Device performance related to safety - Tinnitus SoundSupport feature (optional)

To demonstrate that existing data (T1 and T2 ) meets this requirement, the following steps are taken:
1. Alta2 Pro Ti and Opn 1 is fitted on each patient using their individual hearing loss. The average hearing loss
for the group at the speech important frequencies (1, 2 and 4 kHz) is 41 dB HL (T1) and 36 dB SPL (T2).
2. The prescription of the tinnitus relief sound is done by enabling the Tinnitus sound support tool. The
choice of broadband sound was made individually.
3. Since the overall output level of the tinnitus relief sound is not verified directly on the patient but instead
very accurately simulated in the fitting software (in-situ output, SPLogram). The highest output of the
tinnitus relief sound seen for one of the users in both studies, was 77 dBA (T1) and 71 dBA (T2). Since the
maximum level of tinnitus relief sound do not exceed 90 dB A the requirements on safety using existing
clinical data has been met.
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Overall conclusion
Based on the mitigations including requirements to material, hardware and software, the biological and
technical characteristics of the hearing aid is concluded to be safe to use for the intended clinical purpose
and indication. The overall residual risk of the identified devices is acceptable, and this residual risk is
outweighed by the benefit of the hearing aid. Sufficient safety information is implemented and appropriate
methods for obtaining information from production and post-production are in place. Therefore, it is
concluded that the hearing aids More 1 miniRITE R are safe and effective for the specified intended usage.
Performance
The articles retrieved from the literature report clinical data from the use of wireless hearing aids from a
significant number of patients (over 22.000 patients). The articles are relevant for the device under
evaluation, and no safety issue has been reported related to the physical use of the fitted device. The
evidence for this is quite high.
With adherence to applicable standards, qualitative and quantitative aspects relating to performance of the
device under evaluation, More 1, have been examined to show if the performance of the device meets the
intended purpose and indication. Methods comprise state-of-the-art considerations, pre-clinical bench tests
and verification as well as clinical validation.
In order to assess and substantiate compliance with the requirements, the procedures for Clinical Evaluation
(DOC-0519 SOP Clinical Evaluation), Design Verification (DOC-0050 SOP – Design Verification), Design
Validation (DOC-0051 SOP – Design Validation), Usability Engineering Process (DOC-0309 SOP) and Post-
Market Clinical Follow-up (DOC-0553 SOP – Post-Market Clinical Follow-up) will be followed.
Technical performance
As part of the Design Control process, and with adherence to relevant industry standards (see 5.1), the final
product More 1 miniRITE was verified to assess the maturity/readiness of the product for pre-production.
The verification was done on production equivalent devices. The requirements and their pass criteria are
documented in Demant Hearing Instrument Group’s requirement database DOORS.
The executed verification of the technical performance revealed no non-conformance of the Hearing
Instruments with requirements, and no impact was observed on safety or effectiveness, Product Verification
Report for – Polaris 20.2, P234, Hearing Instruments. Likewise, the fitting software Genie 2 was verified to
assess the maturity and readiness of the delivered product Genie 2 2020.2 for launch to market.
Requirements were met and no impact was observed on safety or effectiveness, P005 Dominica 20H2
Product Verification Report for Genie 2 2020.2.
Clinical performance
In accordance with state-of-the-art, and the above, the following performance requirements can therefore
be concluded to characterize Oticon More 1 when fitted with Oticon Genie 2:
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• Amplification of sound for the individual hearing losses cover:

• Type: Sensorineural, conductive or mixed
• Degree: from slight (16 dB HL*) to profound (95 dB HL*) hearing loss
• Configuration: any individual frequency configuration
* As specified by the American Speech-Language-Hearing Association (asha.org), slight hearing impairment is
considered > 16 dB HL and profound hearing impairment is up to 95 dB HL using pure-tone average of 0.5, 1 and 2
kHz
• Use of evidence based prescriptive fitting rationales in the fitting software ensure a safe and
effective compensation of the individual hearing loss
• Personalization of sound processing schemes according to listening preferences and needs is
possible.
Demonstration on performance requirements from existing clinical data

Data derived from the Oticon More Clinical Evaluation Report [V2] was used to examine the clinical
performance. The following steps were taken:
1. More 1 miniRITE R was fitted on each of the 21 patients included using their individual hearing loss. The
average hearing loss for the speech important frequencies of 0.5,1, 2 and 4 kHz (PTA4) was for the group
of patients 47.7 dB HL (SD 15.6 dB HL) for the right ear and 48.3 dB HL (SD 15.3 dB HL) for the left ear.
The inclusion criteria for the study was designed to match the potential patient population of the More 1
thus cover the indications for use:
a. All classifications of hearing loss (sensorineural, conductive, mixed)
b. All frequency configurations of hearing loss
c. Severity of hearing loss ranging from mild to profound
properties of the ear. The prescription is expressed in insertion gain. The mean value for REIG is for both
ears across all subject 16 dB with a range from 7 dB to 24 dB for the frequencies 0.5 to 4 kHz.
3. Since the insertion gain at speech important frequencies are larger than 0, the SII benefit is also larger
than 0. In other words, the benefit of speech can be demonstrated. SII benefit was estimated individually
for each patient based on the unaided SII for their hearing loss and the aided SII achieved by using the
VAC+ default rationale in Oticon More 1. The unaided SII average was 35% (SD 24.9 %) for the right ear
and 35,1% (SD 22.3 %) for the left ear. The average aided SII was however 60% (SD 16,8 %) for the right
ear and 62,5% (15.5 %) for the left ear, leading to an SII benefit of 25% (SD 13,3%) and 27,4% (SD 14,0%)
for the right and left ear respectively.
Compared to published normative SII ranges, related to the PTA4 hearing loss by Dao et al, (2020) 29 of
the 42 test ears achieved an audibility for More 1, that is within the normative range of audibility
expressed by the aided SII in adult fittings based on DSLv5.
For further 10 test ears the SII were very close to the published normative ranges (9 just below and 1
showing audibility close to the upper limit of the normative range) considering individual needs of
amplification for an experienced HA user. Oticon’s VAC+ fitting rationale is however also known to apply
less gain for low and high frequencies and a bit more gain in the mid frequencies in comparison to DSLv5
for normal speech level at 65 dB SPL. Therefore, it was expected, that the aided SII values would be at
the lower end or just below the normative range of the aided SII.
The mean value of the aided SII for all fittings left and right ear fall within the normative range used to
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assess sufficient audibility by the SII.
4. The speech intelligibility in noise was tested in the lab by means of the Dantale II Matrix test. Speech
perception was demonstrated to be statistically significant better in noise with the amplification provided
by Oticon More 1 compared to unaided, and the speech reception threshold (SRT) is improved (lowered)
by -5.2 dB SNR (p < 0.001), from 2.2 dB down to – 3 dB. For Dantale2, normal hearing listeners have an
SRT of -8.4 dB (Wagener et al ,2003), hence the More 1 can bring the user much closer to the
performance of a normal-hearing listener. Compared to the same measurement made on Opn S 1, Oticon
More 1 reduced the SRT by -0.7 dB, but this difference is not statistically significant, so on this outcome
measure, the two devices can be considered equivalent.
5. In the clinical data of More 1, the Speech, spatial and quality questionnaire SSQ12 was used (Cañete et al
2020), which is a benefit and quality of life questionnaire in the domain of hearing. The reference device
was rated using SSQ12 absolute rating on a 0-10 scale, and the test device, More 1, was later compared
using the SSQ12-C relative +/- 5 scale. The results show that More 1 is rated statistically significantly
better than the benchmark device Opn S 1 (predecessor) overall, and on each of the subscales from the
SSQ: For the Speech subscale, the improvement observed was 1.4 scale points (p < 0.001), for Spatial
hearing the improvement was 0.8 scale points (p < 0.005) and for Qualities of hearing the improvement
was 1.2 scale points (p < 0.001), while the overall improvement was 1.2 (p < 0.001). At the same time, the
initial absolute SSQ12 rating of the Opn S 1 reference device was consistently above norm data (Cañete et
al 2020), indicating that overall, More 1 provides a high benefit.
6. The Quality-Of-Life aspect was tested by means of the clinically validated IOI-HA (Cox et al, 2003;
Thunberg Jespersen et al, 2014), comparing the Oticon More 1 to unaided condition. The IOI-HA asks a
specific question (IOI-HA 7) about the ‘Quality of life improvement’ (QoL) from using hearing aids. The
scoring is based on a 5-point Likert scale with 5 being the best answer. The normative values for the IOI-
HA for the QoL benefit are 3-4 (Cox et al, 2003). The average response from the subjects tested was 3.5
which is within the reported norms and corresponds to the ‘quite a lot’ on ‘Quality of life improvement’.
7. Having established that Oticon More 1 provides a substantial increase in speech understanding in noise
(item 4 above) and also subjective improvement in speech, spatial, and qualities of hearing (SSQ 12) of
Oticon More 1 over Oticon Opn S 1 (item 5 above), and finally the improved Quality of Life (IOI-HA scale 7)
(item 6 above), it shows that Oticon More 1 provides a significant clinical benefit on all three outcome
measures.
Demonstration on performance requirements from existing clinical data on Tinnitus Sound Support
Data derived from validation of the Tinnitus SupportSound feature [T1] was used to examine the clinical
performance of the feature, and that requirements were met. The following steps were taken:
To demonstrate that existing data meets this requirement, the following steps are taken:
1. Alta2 Pro Ti and Opn 1 is fitted on each patient using their individual hearing loss. The average hearing
loss for the group at the speech important frequencies (1, 2 and 4 kHz) is 41 dB HL (T1) and 36 dB SPL
(T2).
2. The prescription of the tinnitus relief sound is done by enabling the Tinnitus sound support tool. The
choice of broadband sound was made individually. The prescription of the tinnitus sound is expressed in
1/3 octave bands together with the hearing threshold levels.
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3. The audibility of the tinnitus relief sound prescription is expressed in how much of the noise that exceeds
the threshold of hearing for each individual. The average audible bandwidth expressed as 95% confidence
interval, is 1,2 to 1,6 octave (T1) and 2,5 to 2,9 octave (T2). Since it is wider than 1,0 octave, the device
claim on audibility has been demonstrated (T1 and T2).
Demant HIG has implemented PMCF processes in 2019, i.e. for all releases since 2019 PMCF Plans have been
implemented. By nature, it takes time to collect the planned data, and results will therefore be available
through PMCF reports from 2021 and forward. For planned PMCF activities please see 5.5.
Based on state-of-the-art and the presented data, preclinical and clinical data for More 1, we conclude that
the Oticon More 1 hearing aids perform as intended by providing the appropriate amount of gain, by
increasing speech intelligibility, and achieving a clinically significant improvement in benefit, and hence user
satisfaction. Furthermore, the studies show that the hearing aids provide a main clinical benefit by
significantly improving health-related quality of life.
Currently there are no data from PMCF studies including equivalent device and actual device. This gap is
taken care of in the planned PMCF activities. In addition to the well-established advanced outcomes used in
Demant for assessing hearing aid benefit in real world and reported in this clinical evaluation, and to reflect
best practice, the planned PMCF activities will also include some immediate outcomes; i.e. real-ear
measurements as well as the Speech Intelligibility Index calculations and evaluations according to normative
data.
However, the overall weight of the reviewed clinical evidence from the literature clearly supports that the
performance levels typically achieved by commercially available wireless hearing aids are appropriate and
positively contribute to clinical practice.
Side effects
Clinical data on safety have been collected from both the scientific literature and own clinical investigations,
which combined contain a significant number of patients and a sufficiently high evidence of the studies. For
the literature studies, the advantages of the data are the large number of the patients enrolled from many
different regions and sites around the world. An assumption regarding literature studies and detection of
side effects is, that a study will report any adverse events that has emerged during the trial. In the literature
of wireless hearing aids, it is extremely rare to find any reports of side effects in a research study. One reason
for this could be that wireless hearing aids are very safe to use and therefore, the incidence of adverse
events in these studies is very low. However, we cannot rule out the possibility of publication bias, where
negative results (like an adverse event) are less likely to be published.
From our own studies on clinical benefit, we have the advantage of collecting potential side effects directly
from the user. However, it is extremely rare that any side effects are reported. Again, this could be a valid
observation since side effects with wireless hearing aids are very rare. The biggest source of reported side
effects is our post-market surveillance system and vigilance databases such as FDA MAUDE.
After review of all available clinical data, we can state that no new side effects have been identified. A known
side effect of hearing aids and earpieces may be an accelerated accumulation of earwax. People with hearing
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aids are informed about this side effect, and regular ear wax removal by an ENT or physician is a well-known
part of wearing hearing aids. The result of this side effect could be an increased risk of clogging the earpiece
of the hearing aids which will result in loss of amplification. These side effects are acceptable. Another known
side-effect is that the otherwise non-allergenic materials used in hearing aids in rare cases may lead to a skin
irritation. This is also deemed acceptable.
More 1 has not yet been released to the market. But an equivalent family of devices currently on the market
have sold 653.223 units of the Opn S 1 and 48.567 units of the Ruby 1 worldwide Since product launch. For
the same time period, only few adverse events (incl. warranty complaint/service and repair events) were
reported (see sections 5.4 and 5.5).
An ongoing process with Input from applicable clinical data, literature, internal clinical studies, PMS and
PMCF will be used to monitor if any new sides effect occur. Should this be the case, these will be mitigated as
part of risk management process and described in the IFU under warnings/documented in the Clinical
Evaluation Report.
Benefit-risk profile
To determine the overall benefit-risk profile of More 1 miniRITE R the following areas were assessed, with
input from the sections 7.1-7.3 and the most relevant state-of-the-art literature (Appendix G, section 3.2, 3.6
and 5.6):
- Intended use and indications for use

- Risk assessment outcome, including mitigation of residual risks and possible side effects
- Complaints, including categories, numbers and percentage related to sales numbers
- Any vigilance cases identified
- Outcome of usability testing of device including IFU
- Pre-clinical bench testing results from design verification
- Own clinical data from actual device, analysis and results
- State-of the-art literature
- Considerations regarding possible gaps in the clinical data
In summary:
Benefit: Oticon More 1 miniRITE R is intended to amplify sounds for a user with hearing loss and
can be fitted to match the individual hearing loss type, degree and configuration.
Data from the extensive state-of-the-art literature, own pre-clinical data and own clinical
studies demonstrate that individually prescribed gain increases audibility (1) and speech
intelligibility index (2). Furthermore, the studies show that the hearing aids provide a
clinically significant improvement in speech understanding (3) in daily life as well as a
main clinical benefit by significantly improving health-related quality of life (4).
Summarizing for each of the 4 clinical outcomes (endpoints) just mentioned and relating
it to the most relevant references from the state-of-the-art literature:
1. Audibility
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Improved audibility is the core delivery of hearing aids. Audibility is typically

quantified along three dimensions, frequency, level and amount of hearing aid
output above threshold. This is ensured by prescription of gain following
amplification rationales, that takes the hearing loss at threshold as input (see for
instance BSA [A2] and NICE [A4] Guidelines for best practice hearing aid fitting).
As described in section 7.2, increased audibility is ensured by amplification

prescription for More 1 for the speech frequencies. To assess if this is sufficient to
ensure improved speech understanding, prescription has been evaluated by means
of the speech intelligibility index.
2. Speech Intelligibility Index

To quantify the effect of audibility in terms of speech intelligibility aggregated across
the dimensions described above, the speech intelligibility index has been developed
(ANSI S3.5 1997 R2007).
Dao et al. (2020) is a peer-reviewed publication that follows the poster presented by
Folkeard et al. in 2018 [A4-17]. It publishes normative data for the aided SII that can
be used to qualify the speech intelligibility improvement for adult hearing aid fittings.
They are used to assess the audibility for conversational speech obtained with More
1 and reported in section 7.2 above.
The normative SII range for the aided SII achieved by the amplification provided for
conversational speech at a level of 65 dB SPL related to an average PTA4 of 48dB HL,
found in the More 1 study for both ears, is by Dao et al. reported as a range from
60% to 77%. The mean value for the aided SII achieved on average for all subjects
fitted with More 1 was 60% (SD 16.8 ) for the right ear and 62% (SD 15.5) for the left
ear. Both values fall within the normative range used to assess sufficient audibility by
the SII.
Investigating the individually achieved aided SII values for conversational speech
found for More 1 fitted using Oticon’s VAC+ fitting rationale, 29 of the 42 test ears
achieved an aided audibility, that is within the normative range of audibility
expressed by the aided SII in adult fittings based on DSLv5. For further 10 test ears
the aided SII values were very close to the reported normative ranges (9 just below
and 1 showing audibility close to the upper limit of the normative range). This
reflects the individual adjustments of amplification required from experienced HA
users and the use of the VAC+ fitting rationale.
Oticon’s fitting rationale VAC+ is known to apply slightly less gain for low and high
frequencies and a bit more gain in the mid frequencies when compared to the DSLv5
adult fitting rationale at conversational speech level. Therefore, it was expected, that
the aided SII values would be at the lower end of normative range of the aided SII
published.
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Relating the 60-62% SII obtained with More 1 to the published norm data, it can be
confirmed that the obtained speech intelligibility falls within the acceptable ranges.
3. Speech Understanding
In the lab, by using Dantale II, speech perception was demonstrated to be statistically
significant better in noise with the amplification provided by Oticon More 1
compared to unaided, and the speech reception threshold (SRT) is improved by -5.2
dB SNR (p < 0.001), which is a large benefit.
Furthermore, data from the clinical evaluation study (V2) reported on in section 7.2
shows that More 1 provides clinically significant improvements in speech
intelligibility and these improvements apply to those situations where people with
hearing impairment suffer without hearing aids that are effective at providing
benefits in complex noisy situations, see for instance Noble and Gatehouse 2006 [A5-
057].
4. Health-Related Quality of Life
The Speech, Spatial and Qualities (SSQ) of life is recognized self-report outcome
measures that have been used extensively in the literature. Norm data exist for the
outcome measures, see for instance Gatehouse and Noble 2004 [A5-001].
In the clinical evaluation test, the 12-item comparative SSQ (SSQ-12C) was
administered (Noble et al, 2013), providing a relative rating of More 1 vs Opn S 1.
The results from the SSQ12-C questionnaire shows that More 1 is rated significantly
better than the benchmark device Opn S 1. At the same time, the initial absolute
SSQ12 rating of the Opn S 1 reference device was consistently above norm data
(Cañete et al 2020), indicating that overall, More 1 provides a high benefit.
In evaluating the improvements in quality of life (QoL) provided by Oticon More 1,

the standardized questionnaire IOI-HA was used, as it includes the question:
“Considering everything, how much has your present hearing aid(s) changed your
enjoyment of life?” with the possible answer choices being: 1) worse, 2) no change,
3) slightly better, 4) quite a lot better and 5) very much better.
More 1 scored in average 3.5 on this question, which is within the normative range
of 3-4 reported by Cox et al. (2003).
With the results from SSQ12-C and IOI-HA, it can be concluded that More 1 provides
improvements on quality of life.
Usability data have shown that the device is safe and easy to use. For the hearing-
impaired user, there are often no alternatives to a hearing device as a therapeutic
option, when the hearing loss is mild to severe.
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Risk: The device, More 1 miniRITE R, has low risk, and all risks are reduced as far as possible.
The most pronounced clinical hazard is the risk of damage to the hearing due to high
sound pressure levels (i.e. exceeding 132 dB SPL). However, no matter fitting level, the
device has a limited maximum power output (MPO) implemented both in software as
well as hardware to limit to the output.
The literature appraisal has identified two references of specific value to this discussion.
In Johnson 2017 [A3-01] it is concluded that amplification prescription ensures that the
hearing aid output is limited to safe levels. For input levels about 80 dB SPL, Johnson
2017 [A3-01] identifies that the hearing aid output is close to the safe limits determined
by the modified power law (MPL). The MPL is also used by McCreery et al 2017 [C4-01] in
evaluating potential hearing threshold shift longitudinally, based on data from at least 4
years of observation between hearing threshold assessments, when using hearing aids.
McCreery and colleagues conclude that they observe no increase in thresholds over the
study period and therefore argues that the MPL is overestimating the risk for hearing
threshold shift. Based on this specific work, it is concluded that hearing aids are safe to
use long term.
There are two known possible side-effects from using a hearing aid, including More 1.
One is the accelerated accumulation of earwax and the other is rare cases of skin
irritation even by using the otherwise non-allergenic materials in hearing aids.
From the complaints data we know that there are no other general issues of risks, that
could affect the safety and health of the patient.
Benefit-risk: From the above analysis of the benefit on the chosen outcomes and limited risk
identified, we conclude that the overall benefit of the More 1 miniRITE R outweighs the
risk of use.
The benefit-risk profile of More 1 miniRITE R when used as intended is clearly favorable
Lifecycle considerations
The device under evaluation with the purpose of showing MDR compliance, More 1 miniRITE R, is planned to
be introduced to the market in December 2020 (under MDR 2017/745).
Several processes are linked to the lifecycle of the hearing aid after product release (M4): The Clinical
Evaluation Plan (CEP) plans what needs to be done through product lifecycle, the Clinical Evaluation Report
(CER) collects all the results from the underlying processes and will be updated when needed, but at least
every second year. The underlying processes are the re-active and pro-active post-market surveillance
processes from Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Complaints and
Vigilance processes as well as the Design Change Process are linked into the PMS system and follow the
product lifecycle as specified in section 2.11. Results from PMCF investigations will be reported in the PMCF-
Report related to the product release PrR of the specific hearing aid. The PMCF-Report is used as input to the
Periodic Safety and Usability Report PSUR, which will be written / updated at least every second year
through-out the lifecycle of the hearing aid. Complaints that lead to design changes of the hearing aid or the
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accessories as well as vigilance cases may initiate a PMCF study which will be covered by the next
subsequently following PMCF-Plan. PMCF-Plans are created following the product release cycle done
typically twice a year.
8 Conclusions
The purpose of this Clinical Evaluation was to demonstrate conformity of the Oticon More 1 miniRITE R
wireless hearing aid with the General Safety and Performance Requirements set out in the MDR 2017/745.
The clinical evaluation process sought to identify, according to plan, relevant scientific data available in the
public domain and on internal records held by the manufacturer regarding the safety and performance of
Oticon More 1 miniRITE R.
Based on the literature review, the outcomes of our clinical studies, the number of years on the market for
equivalent devices, the number of complaints for equivalent devises, and the management of any risks in the
risk assessment, it can be concluded that the Oticon More 1 wireless hearing aids are safe to use.
According to bench testing in conformity with applicable standards, the Oticon More 1 can withstand worst-
case manipulation during use when operated according to the Instructions for Use without compromising
patients’ safety. No new safety issues that have not already been mitigated by risk control measures, have
been seen in the literature and safety databases related to wireless hearing aids, neither from Oticon, other
brands from Demant HIG nor the competitors.
There is full consistency between current knowledge/the state of the art, the available clinical data, the
manufacturer's product information and the risk management documentation for the device. In summary,
the Oticon More 1 miniRITE R is shown to be safe and have a very low risk profile.
The performance of wireless hearing aids, when used for the intended purpose, has been well-established in
the literature, clinical data and pre-clinical testing. The clinical data of More 1 demonstrate that these
devices perform as good and satisfactory as state-of-the-art. This allows us to assume that the Oticon More
model will also fulfill the performance requirements set out in the MDR. The benefit of Oticon More 1
miniRITE R to the patients clearly outweigh the potential risks.
Residual risks and uncertainties have been sufficiently identified. The acceptability for CE-marking is
sufficiently discussed and follow-up measures during PMS are addressed. This includes uncertainties
regarding mid- and long-term performance, safety under wide-spread use, residual risks such as side effects
and complications occurring at rates below detection possibilities of currently available clinical data. Risks
and uncertainties are already addressed in ongoing PMS activities (e.g. in currently ongoing PMCF studies).
The clinical validation of the device under evaluation was performed to demonstrate conformity with the
requirements of the MDR 2017/745.
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The reviewed clinical evidence substantiates compliance of the Oticon More 1 miniRITE R wireless hearing
aids with the General Safety and Performance Requirements of the MDR, in particular with requirements
number 1 and number 8 (as well as GSPR 2, 4 and 5). The devices perform as intended by the manufacturer
and are safe under normal conditions of use. The safety and performance of the Oticon hearing aids are
comparable to those of benchmark devices in accordance with the state of the art in the concerned medical
field. All known and foreseeable risks have been minimized by risk mitigation and other risk management
measures. Any residual risks associated with their use are acceptable when weighed against the evaluated
benefits to the patient arising from the achieved performance of the device. Residual risks and unanswered
questions can be followed during post-market surveillance activities conducted by the manufacturer on a
routine basis, including PMCF studies.
9 Date of the next clinical evaluation
In accordance with DOC-0519 SOP Clinical Evaluation, a new clinical evaluation will take place if triggered by
e.g. post-market input, applicable new literature, and no later than 2 years after the release of the equivalent
product, i.e. at the latest in December 2022.
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10 Qualification of evaluators
The following persons were involved in this Clinical Evaluation. They were chosen because of the adequate
skills and knowledge about both device technology and research methods, but also technical, medical and
therapeutic knowledge, as well as regulatory knowledge.
Christina Degn Frary

Clinical audiologist, MA. Audiologopedics, Demant
Conflict of interest: None
Lars Bramsløw
Senior scientist, MSc., Ph.D., Eriksholm Research Centre (Demant)
Eva Andreasson
Product Owner Software Solutions, Clinical audiologist, U.C. In diagnostic audiology and audiotherapy,
Demant
Joanna Rzędzian
Busines Analyst, Clinical audiologist, Demant
Christina Bach Pilegaard Søholm

Regulatory Affairs Manager, Bachelor of Biomedical Laboratory Science (BBiomedSc), Demant
Dragan Gusatovic
Clinical Audiologist, Audiological Assistant, Demant
Henrik Lodberg Olsen

Clinical audiologist, MSc., Ph.D., Demant
Louise Würtz Jørgensen

Regulatory Affairs Manager, MSc., Eng., Demant
Monika Baumann
Manager for Post Market Research and Audiology Compliance, BSc Technical Audiology, Audiologist,
Pediatric Audiologist, Oticon A/S
Thomas Behrens
Chief of Audiology, MSc., Oticon A/S
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Curriculum vitae of the responsible evaluators are provided on request. Declarations of Interest are retained
by the manufacturer.
Table 48: Qualifications of Evaluators

Intended treatment/ diagnosis
Information management
Regulatory requirements
Technology/ application
Research methodology
Medical writing
Short profile
company
Function
Name/
Clinical/R&D Henrik L Olsen X X X X Over 20 years of experience with

hearing aids technology and fitting
in clinics and in research
Lars Bramsløw X X X X Over 20 years of experience with
hearing aids technology and
development
Christina Degn X X X X 7 years of experience with hearing
Frary aids technology and fittings in
clinics and research
Eva Andreasson X X X Over 20 years of experience with
hearing aids technology and
development
Monika X X X Over 20 years of experience with
Baumann hearing aids fitting in clinics and
development
Dragan X X Over 20 years of experience with
Gusatovic hearing aids fitting in clinics and
development
Joanna Rzędzian X X X Over 10 years of experience with
hearing aids fitting in clinics and
development
Quality & Chistina Bach X X X Over 20 years of experience with
Regulatory Pilegaard regulatory work and development
Søholm
X X X Over 3 years of experience with
Louise Würtz regulatory work and development
Jørgensen
Audiology Thomas Behrens X X X X Over 20 years of experience with

Management hearing aid technology and
research
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11 Appendices
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Document location:
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Appendix B: Internal documents
11.2.1 Pre-clinical Data
Products
Classification - Intended Use
Oticon More 1 Checklist for Requirement Review and Approval for P234 Polaris Oticon
(hearing aid) Doc id: 0901c76e809dec80
Product Verification Report for – Polaris 20.2, P234, Hearing Instruments

Doc id: 0901c76e808714e4
Genie 2 Checklist for Requirement Review and Approval for P005 Genie 2 – Release
(fitting software) 2020.2
Doc id: 0901c76e809cb396
P005 Dominica 20H2 Product Verification Report for Genie 2 2020.2

Doc id: 0901c76e80a015b5
11.2.2 Clinical Data
Authors
Studies
Oticon More Clinical Evaluation Report
Bramsløw, L; Iven, M. (2020)
Doc id: 0901c76e80a13da2
Caron, A-M; Olsen, H. L. Validation Results Report – Oticon More 1 miniRITE R, P234
(2020) Doc id: 0901c76e80a0d224
Usability Engineering Report for Polaris 20.2 P234 Oticon – miniRITE-R
Robertson, A. (2020)
Doc id: 0901c76e80898a5b
Caron, A-M; Mathiesen, E; Validation Results Report Oticon Opn S 1 BTE PP/miniRITE R, P232
Gusatovic, D. (2019) Doc id: 0901c76e808d2d6c
Nøhr Demant, L. (2019) Usability Engineering Report for Marvel 19.1 P232 Oticon Opn S, Opn
Play - miniRITE R
Doc id: 0901c76e808986ff
Hafez, A (2015) Validation Results Report – Oticon for Eclipse+ P140
Doc id: 0901c76e804c09c4
Hafez, A (2017) 17.1 Oticon Opn 1 incl. TSS Product Test Report
Doc id: 0901c76e806dbc2a
11.2.3 Classification and Intended Use
Document location:
Documentum
Products
Classification - Intended Use
Oticon More 1 IU2017-02- Classification and Intended Use – Hearing Instruments and
Tinnitus Maskers – Polaris
Doc id: 0901c76e8077b700
Oticon Opn S 1 IU2015-11 Classification - Intended Use - Hearing Instruments and
Tinnitus Maskers - Marvel (17.2, 18.2, 19.1)
Doc id: 0901c76e80529f9a
Charger IU2016-07 Classification - Intended Use - Desktop Charger
Doc id: 0901c76e8062d9af
Genie 2 Classification and Intended Use- Medical Device Software Fitting
- fitting software software – Phoenix
Doc id: 0901c76e80998f88
Remote Fitting App IU 2020-07 Classification - Intended Use – Medical Device Software –
(incl. Oticon RemoteCare Remote Fitting App
App) Doc id: 0901c76e80999027
ConnectClip IU2015-05 Classification - Intended Use – Accessories – AudioClip
Doc id: 0901c76e80506c1b
TV Adapter IU2015-03 Classification - Intended Use - Accessories - TV Adapter 3
Doc id: 0901c76e80506cf6
Remote Control IU2015-01 Classification and Intended Use – Accessories – Remote
Control 3
Doc id: 0901c76e804fac62
Remote Control App IU 2020-04 Classification and Intended Use – Medical Device Software
(incl. Oticon ON App) – Remote Control App – MDR release
Doc. No. 0901c76e80962bb4
Phone Adapter IU2016-02 Classification - Intended use - Phone Adapter 2
Doc id: 0901c76e805b5740
EduMic IU2018-07 Classification - Intended use - Accessories - NEWT
Doc id: 0901c76e8082ea08
11.2.4 Risk management documents
Products
Risk Assessment and Risk Management Report
Oticon More 1 Risk Assessment - Hearing Instruments and Tinnitus Maskers - Polaris
20.2
Doc id: 0901c76e8098bbe7
Risk Management Report - Oticon - More
Doc id: 0901c76e809d635b
Oticon Opn S 1 Risk Assessment for - Hearing Aids - Marvel Product Program
Doc id: 0901c76e8052d71b
Risk Management Report for Oticon – Opn S 1l2l3, Opn Play 1l2,
Engage – miniRITE, miniRITE T, BTE PP, BTE 13M, miniRITE R
Doc id: 0901c76e8086611d
Charger Risk Assessment for - Charger - Marvel
Document location:
Documentum
Doc id: 0901c76e80673fbe

Risk Management Report for Oticon Charger
Doc id: 0901c76e808de92e
Genie 2 Risk Assessment fitting software - Phoenix 20.2
- fitting software Doc id: 0901c76e8099ee46
Risk Management Report for Oticon Fitting Software Genie 2
Doc id: 0901c76e809e56bc
Remote Fitting App Risk Assessment for Remote Fitting App
(incl. Oticon RemoteCare Doc id: 0901c76e8099ee47
App) Risk Management Report - Oticon RemoteCare App 20.2
Doc id: 0901c76e809e5709
ConnectClip Risk Assessment for AudioClip / ConnectClip / SoundClip-A
Doc id: 0901c76e80506778
Risk Management Report for Oticon ConnectClip
Doc id: 0901c76e80797d71
TV Adapter Risk Assessment for TV Adapter 3
Doc id: 0901c76e80506b3a
Risk Management Report for Oticon TV Adapter 3.0
Doc id: 0901c76e805fa846
Remote Control Risk Assessment for Remote Control 3
Doc id: 0901c76e80506745
Risk Management Report for Oticon Remote Control 3.0
Doc id: 0901c76e805fa846
Remote Control App Risk Assessment - Remote Control App
(incl. Oticon ON App) Doc id: 0901c76e8097cb75
Risk Management Report for Oticon ON
Doc id: 0901c76e809e0aed
EduMic Risk Assessment for – NEWT - Gotham
Doc id: 0901c76e80805214
Risk Management Report for Oticon – EduMic
Doc id: 0901c76e8091dc4e
Phone Adapter Risk Assessment for Phone Adapter 2
Doc id: 0901c76e809a3c56
Risk Management Report for Oticon Phone Adapter 2
Doc id: 0901c76e809c2a00
11.2.5 Instruction for Use
Products
Instruction for Use/User Guides
Oticon More 1 219448UK_IFU_Oticon_More_miniRITE_R
Doc id: 219448 /2020-07-20
Oticon Opn S1 214211UK_IFU_Opn_S_Opn_Play_Ruby_miniRITE_R.pdf
Doc id :214211/2019-11-05
Document location:
Documentum
Charger 214213UK_IFU_Charger_Oticon_miniRITE_R.pdf
Doc id: 221230/2020-09-15
Oticon Genie 2 219355UK_IFU_Genie_2_2020.2.pdf
Doc id: 219355/2020-07-07
Remote Fitting App 221129UK_IFU_RemoteCare_App_3.1.0_MFI_Android.pdf
(Oticon RemoteCare App) Doc id: 221129/2020-07-29
Connect Clip 220286GB_IFU_2.4G_Connectclip_1.0_HHM_MDR
Doc id: 22028/2020-04-27
TV Adapter 214146UK_IFU_2.4G_TV_Adapter_3.0_MDR.pdf
Doc id: 214146/2020-03-13
Remote Control 214690UK_IFU_2.4G_Remote_Control_3.0.PDF
Doc id: 214690/2020-02-07
Remote Control App 223230UK_IFU_Oticon_ON_App_2.3.0_press.pdf
(incl. Oticon ON App) Doc id: 223230/2020-09-02
EduMic IFU: 214701UK_IFU_EduMic_MDR
Doc id: 214701/2020-02-25
Phone Adapter IFU: 219521UK_IFU_Connectline_Phone_Adapter_2.0_MDR
Doc id: 219521/2020-02-27
11.2.6 Post-Market activitites
Products
PMCF Plans
Oticon More 1 Post-market Clinical Follow-up Plan for Product Release PrR 20.2
Doc id: 0901c76e80a0c1ee
Oticon Opn S 1 Post-market Clinical Follow-up Plan for Product Release PrR 19.1 & 19.2
Doc id: 0901c76e80929258
Products
PMS Plans
Oticon More 1 Post Market Surveillance Plan for Oticon Hearing Instruments–More
Doc id: 0901c76e809d5559
Oticon Opn S 1 Post Market Surveillance Plan for Oticon Hearing Instruments – Opn S
Doc id: 0901c76e80942012
Document location:
Documentum
Appendix C – Commercial feature overview
Oticon More 1 miniRITE R - Commercial feature overview
Document location:
Documentum
Oticon Opn S 1 miniRITE R - Commercial feature overview
Document location:
Documentum
Appendix D: Data collection report for wireless hearing aid technology
11.4.1 Data collection
11.4.1.1 Purpose and scope
The data of State-of-the-art hearing aid technology is to be used for Clinical Evaluation of wireless hearing
aids. The search aims to cover specific aspects of state-of-the-art hearing aid technology.
11.4.1.2 Data sources
Relevant articles and reports search in

• PubMed data base http://www.ncbi.nlm.nih.gov/pubmed
• Cochrane database https://www.cochranelibrary.com/
11.4.1.3 Inclusion criteria

The inclusion criteria are shown in Table 49 below.
Table 49: Inclusion criteria

Inclusion criteria Rationale
Language English Sufficient number of publications in English.
Population No clinical data needed. Data should be descriptive and not experimental
Outcome Technical articles or reviews Reflecting national or international state-of-the-art
Time frame 31/05 2010 until 31/05 2020 The time frame allows inclusion of data from
versions/models that are relevant (equivalent in
intended use to devices under evaluation).
11.4.1.4 Exclusion criteria
• No description of specific devices.

• Devices other than commercial wireless air conduction devices, i.e. no CI, BAHA
• Another language than English
Table 50: PubMed search for HAFM

Date 05/31 2010 – 05/31 2020 (Adults and children)
Database PubMed
Search Keywords (search details translation) Number of

publications
D1 Included: Hearing aid, State-of-the-art 18
Excluded: Implant
Date: 31/05 2010- 31/05 2020
Document location:
Documentum
("State-of-the-art"[All Fields] AND "hearing aid"[All Fields]) NOT

"implant"[All Fields]
Table 51: Cochrane search for hearing aid technology
Database Cochrane
publications
D2 Included: Hearing aid, State-of-the-art 0 reviews
Excluded: None
Date: 31/05 2010- 31/05 2020
"hearing-aid" in Title Abstract Keyword AND state-of-the-art in Title

Abstract Keyword - with Cochrane Library publication date from Jan to
present (Word variations have been searched)
11.4.2 Data selection
The following papers were retrieved by the search for the state of the art hearing aid technology.
Table 52: Results from the state-of-the-art search for hearing aid technology
Reference Relevance Source
Kollmeier, B., Kiessling, J. (2016): Highly. Provide solution-oriented PubMed
Functionality of hearing aids: overview of current hearing
state-of-the-art and future features: benefits and
model-based solutions. counterproductive aspects
Hoppe U, and Hesse G. Hearing Highly. Focus on functional PubMed
aids: indications, technology, principle of modern digital
adaptation, and quality control. hearing devices
Document location:
Documentum
11.4.3 Additional search on SSQ
11.4.3.1 Purpose and scope
In the planned clinical evaluation, the SSQ12 questionnaire (Noble et al, 2013) will be included. Since it was
not included in the above search, an additional search was done for SSQ applied to adults in relation to
hearing aid performance. The search should include both the original SSQ49 (Gatehouse and Noble (2004)
and later derivatives, including the SSQ12.

• The clinical trial database https://clinicaltrials.gov/
Table 53 Inclusion Criteria

Population Adults older than 18 years Data to be used for clinical evaluation, thus only
clinical data
Outcome Safety and performance outcomes. Clinical data on safety and performance, as outlined
in the guideline
Time frame 30/6 2007 until 31/10 2020 (A) The time frame allows inclusion of data from
• No description of specific devices.

• Not using the SSQ
• Not completed, not with results
Table 54 Pubmed search for SSQ

Date 20070630-20201031 (A)
Database PubMed

publications
A2 Included: Hearing aid and SSQ 19
Excluded: BAHA, Cochlear Implant, Cros, Children, Tinnitus
Date: 20070630-20201031
Document location:
Documentum
("State-of-the-art"[All Fields] AND "hearing aid"[All Fields] AND

“SSQ”[All Fields]) NOT "implant"[All Fields]
Table 55 ClinicalTrials.gov search for SSQ

Date 20070630-20201031 (A)
Database ClinicalTrials.gov

publications
A2 Included: Hearing aid and SSQ (Completed trials, With results) 2
Excluded: BAHA, Cochlear Implant, Cros, Children, Tinnitus
Date: 20070630-20201031
https://clinicaltrials.gov/ct2/results?term=SSQ+hearing+aids&recrs=e&ag
e_v=&gndr=&type=&rslt=With&Search=Apply
The following papers were retrieved by the search for the state of the art hearing aid technology using SSQ.
Table 56: Results from the state-of-the-art search for SSQ questionnaire
Akeroyd MA, Guy FH, Harrison DL, High. Analyzing the underlying PubMed
Suller SL (2014). A factor analysis of properties of SSQ49 on a large group
the SSQ (Speech, Spatial, and of listeners at different ages and
Qualities of Hearing Scale). hearing losses.
Ng EH, Rudner M, Lunner T, Medium. Comparing SSQ and IOI-HA PubMed
Rönnberg J. (2014). Relationships measures to cognitive predictors in
between self-report and cognitive hearing aid users.
measures of hearing aid outcome.
Anderson M, Rallapalli V, Schoof T, High. Using SSQ49 to reveal PubMed
Souza P, Arehart K. (2018). The use differences in signal processing with
of self-report measures to examine a significant effect detected.
changes in perception in response to
fittings using different signal
processing parameters.
Matsumoto N, Suzuki N, Iwasaki S, High. Using SSQ to investigate a PubMed
Ishikawa K, Tsukiji H, Higashino Y, language-specific fitting rationale. No
Tabuki T, Nakagawa T. (2018). effect detected.
Language-specific strategy for
programming hearing aids – A
double-blind randomized controlled
crossover study.
Humes LE, Kidd GR, Lentz JJ. (2013). Medium. Testing the relation PubMed
Auditory and cognitive factors between predictive factors and SSQ
underlying individual differences in outcomes. Both norm-data and test-
retest data provided.
Document location:
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aided speech-understanding among

older adults.
NCT02448706: Souza: Variability In Reported in Anderson et al (2018), clinicaltrials.gov
Hearing Aid Outcomes In Older see above in this table.
Adults (2017)
NCT00371449: Predicting Success Medium: Correlating both SSQ and clinicaltrials.gov
With Hearing Aids (2015) IOI-HA outcomes to Acceptable
Noise Levels (ANL) test and to words-
In-Noise score.
Appendix E: Data collection report for equivalent devices
11.5.1 Purpose and scope
Clinical data of the specific hearing devices will be used for Clinical Evaluation of wireless hearing aids. The
specific device included in the search were equivalent device (Opn S incl. Ruby) to Oticon More 1.
11.5.2 Data sources
• PubMed data base https://pubmed.ncbi.nlm.nih.gov/

• PubMed central data base http://www.ncbi.nlm.nih.gov
• ClinicalTrials.gov database https://clinicaltrials.gov
11.5.3 Inclusion criteria
Table 57 Inclusion criteria

Children, 3-18 years clinical data
in the guideline
Intervention/device Original clinical data on the specific Data to be used for clinical evaluation, thus only
wireless air conduction hearing aid. clinical data. To ensure sufficient screening for
safety-related outcomes all versions/models of
wireless hearing aids are included.
Document location:
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11.5.4 Exclusion criteria
Table 58. Search in PubMed for equivalent device
Database PubMed

publications
S3 Included: Oticon Opn S “equivalent device” 0
Excluded: None
Date: 31/05 2010- 31/05 2020
«Oticon Ruby»
Excluded: None
Date: 31/05 2010- 31/05 2020
«Oticon Opn S»
Table 59. Search in PubMed Central for equivalent device
Database PubMed Central

publications
Excluded: None
Date: 31/05 2010- 31/05 2020
«Oticon Opn S»
Document location:
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Excluded: None
Date: 31/05 2010- 31/05 2020
« Oticon Opn S »
Table 60. Search in ClinicalTrial.gov for equivalent device
Database ClinicalTrial.gov

publications
S3 Included: Oticon Ruby “equivalent device” 0
Excluded: None
Date: 31/05 2010- 31/05 2020
«Oticon Ruby»
Excluded: None
Date: 31/05 2010- 31/05 2020
«Oticon Opn S»
Data selection
After further data selection of the 17 publication from PubMed and PubMed Central, it is concluded that no
published clinical data is available for Oticon Opn S and Oticon Ruby.
Appendix F: Data collection report for hearing aid fitting management (HAFM)
This part of the search focused on protocols and guidelines aiming to cover
Document location:
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1. Clinical data relevant to the device under evaluation to establish the clinical safety and performance
of wireless hearing aids and implant accessories, when used as intended.
2. Clinical data that relate to state-of-the-art hearing aids to identify potential clinical hazards.
The review was carried out in accordance with “MEDDEV.2.7.1 Rev 4, June 2016. Guidelines on medical
devices, Clinical Evaluation: A guide for manufacturers and notified bodies”.
11.7.2 Data sources

• National guidelines with public access
• Books
• Standards

Population Adults hearing aid fitting Data to be used for adult and pediatric hearing aid
Children hearing aid fitting fitting
Outcome Protocols or guidelines Reflecting national or international state-of-the-art

HAFM modules Complete protocols or guidelines, As a minimum assessment, fitting and follow-up
taking all of the fitting process into should be included.
account.
Two limiting factors were found in this process. First, some audiological societies only offer guidelines to
their members and not to the public. Here, public access has only been included. Second, many societies do
not have an ongoing renewal of their guideline, which means that many will be considered obsolete within
the timeframe of 10 years.
Document location:
Documentum
• Studies on evaluation or efficiency of a specific protocol and guidelines

Table 62: PubMed search for protocols and guidelines

Database PubMed

publications
A1 Included: Hearing aid, protocol guidelines 85
Excluded: Cochlea, bone, tinnitus, implant
Date: 31/05 2010- 31/05 2020
(("hearing aids"[MeSH Terms] NOT ((((("cochlea"[MeSH Terms] OR

"cochlea"[All Fields]) OR "cochlear"[All Fields]) OR ("tinnitus"[MeSH
Terms] OR "tinnitus"[All Fields])) OR ((("bone and bones"[MeSH Terms]
OR ("bone"[All Fields] AND "bones"[All Fields])) OR "bone and bones"[All
Fields]) OR "bone"[All Fields])) OR ((((((((((((((((((("embryo
implantation"[MeSH Terms] OR ("embryo"[All Fields] AND
"implantation"[All Fields])) OR "embryo implantation"[All Fields]) OR
"implantation"[All Fields]) OR "implant"[All Fields]) OR "implant s"[All
Fields]) OR "implantability"[All Fields]) OR "implantable"[All Fields]) OR
"implantables"[All Fields]) OR "implantate"[All Fields]) OR
"implantated"[All Fields]) OR "implantates"[All Fields]) OR
"implantations"[All Fields]) OR "implanted"[All Fields]) OR "implanter"[All
Fields]) OR "implanters"[All Fields]) OR "implanting"[All Fields]) OR
"implantion"[All Fields]) OR "implantitis"[All Fields]) OR "implants"[All
Fields]))) AND (((("protocol"[All Fields] OR "protocol s"[All Fields]) OR
"protocolized"[All Fields]) OR "protocols"[All Fields]) OR
(("guideline"[Publication Type] OR "guidelines as topic"[MeSH Terms]) OR
"guidelines"[All Fields]))) AND 2010/5/31:2020/5/31[Date - Publication]
Table 63: Cochrane search for protocols and guidelines

Database Cochrane
publications
A1 Included: Hearing aid, protocol guidelines 46 trials
Excluded: Cochlea, bone, tinnitus, implant 1 review
Date: 31/05 2010- 31/05 2020
"hearing-aid" in Title Abstract Keyword AND protocol OR guidelines in

Title Abstract Keyword NOT cochlea OR tinnitus OR bone OR implant in
Document location:
Documentum
Title Abstract Keyword - with Cochrane Library publication date Between

Jan 2010 and May 2020 (Word variations have been searched)
The following papers were retrieved:

Anderson MC, Arehart KH, Souza Included as a survey for adults PubMed
PE. Survey of Current Practice in
the Fitting and Fine-Tuning of
Common Signal-Processing
Features in Hearing Aids for
Adults.
Rodrigues-Sato LCCB, Almeida K. Included as a guideline for adults PubMed
Clinical protocol for Hearing
Health Services for the care of
adults and elderly.
Bagatto MP, Moodie ST, Included as a guideline for PubMed
Malandrino AC, Richert FM, children
Clench DA, Scollie SD. The
University of Western Ontario
Pediatric Audiological Monitoring
Protocol (UWO PedAMP).
Feirn R. (2014). Guidelines for Included as a guideline for PubMed
Fitting Hearing Aids to Young children
Infants
11.7.6 Adults
This general framework includes all the necessary components for a best practice state-of-the-art of HAFM.
Table 64 summarizes the essential components of hearing aid fitting guidelines globally (one standard and 15
guidelines) consisting of 11 components: counseling, audiometry, hearing aid evaluation, hearing aid
selection, ear impression, adjustment, verification, orientation, auditory training, outcome measures, and
comprehensive report. It is evident that most of these components are common across the guidelines
although each guideline includes slightly different components.
Table 64: Classification of guidelines for adults

Assessment Fitting Follow-up
Ref Country Counse- Audio- HA Ear Adjust- Verifi- Orien- Aud train Out Comp
ling metry selection impres ment cation tation come report
sion
A1 AUS x x x x x x x x x x
A2 CAN x x x x x x x x xG
A3 EU x x x x x
A4 UK x x x x x
A5 INT x x x x x x x x x x
A6 US x x x x x x
Document location:
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A7 BRA x x x x x x x x
A1: Australia: Dillon, H (2012). Hearing aids. 2nd edition. Boomerang press
A2: Canada: CASPLO. (2016). Practice Standards for the Provision of Hearing Aid Services By Audiologists.
Ontario, Canada
A3: Europe: EUHA. (2020).10-step catalogue on the quality of hearing aid fitting. Europäische Union der
Hörakustiker.
A4: UK: NICE. (2018). Hearing loss in adults: assessment and management. National Institute of Health and
Care excellence. NICE guideline [NG98]
A5: ISO 21388:2020 (2020). Hearing aid fitting management (HAFM). Geneva, Switzerland.
A6: Literature search: Andersson et al., (2018): Survey of Current Practice in the Fitting and Fine-Tuning of
Common Signal-Processing Features in Hearing Aids for Adults
A7. Literature search: Rodrigues and Almeida, (2018) Clinical protocol for Hearing Health Services for the care
of adults and elderly.
11.7.7 Children
The same framework has been applied for children.
Table 65: Classification of guidelines for children

Assessment Fitting Follow-up
Ref Country Counse- Audio- HA Ear Adjust- Verifi- Orien- Aud train Out Comp
ling metry selection impres ment cation tation come report
sion
C1 AUS x x x x x x x x x x
C2 CAN x x x x x x x x x
C3 UK x x x x x x x x x x
C1: Australia: Dillon, H (2012). Hearing aids. 2nd edition. Boomerang press
C2: Canada: Bagatto MP, Moodie ST, Malandrino AC, Richert FM, Clench DA, Scollie SD. The University of
Western Ontario Pediatric Audiological Monitoring Protocol (UWO PedAMP). Trends Amplif. 2011 Mar-
Jun;15(1):57-76
C3: UK: Feirn R. (2014). Guidelines for Fitting Hearing Aids to Young Infants. Children’s Hearing Centre,
University Hospitals Bristol, UK
Document location:
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Appendix G: Data collection report for tinnitus management program
This part of the search focused on protocols and guidelines aiming to cover clinical data relevant to the
device under evaluation to establish the clinical guideline and recommendation of tinnitus management and
treatment.
11.8.2 Data sources

• National guidelines with public access
• Books
• Standards

Population Adults hearing aid fitting Data to be used for adult and pediatric hearing aid
Children hearing aid fitting fitting
Outcome Protocols or guidelines Reflecting national or international state-of-the-art

Tinnitus Complete protocols or guidelines, As a minimum assessment, XXXXX and treatment
management taking all of the tinnitus process should be included.
modules into account.
Two limiting factors were found in this process. First, some audiological societies only offer guidelines to
their members and not to the public. Here, public access has only been included. Second, many societies do
not have an ongoing renewal of their guideline, which means that many will be considered obsolete within
the timeframe of 10 years.
Document location:
Documentum
• Studies on evaluation or efficiency of a specific protocol and guidelines

Table 67: PubMed search for protocols and guidelines

Date 05/31 2010 – 05/31 2020 (Adults)
Database PubMed

publications
G1 Included: Tinnitus, guidelines, treatment 62
Excluded: None
Date: 31/05 2010- 31/05 2020
((("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields]) AND

(("guideline"[Publication Type] OR "guidelines as topic"[MeSH Terms]) OR
"guideline"[All Fields])) AND (((((("therapeutics"[MeSH Terms] OR
"therapeutics"[All Fields]) OR "treatments"[All Fields]) OR
"therapy"[MeSH Subheading]) OR "therapy"[All Fields]) OR
"treatment"[All Fields]) OR "treatment s"[All Fields])) AND
2010/5/31:2020/5/31[Date - Publication]

Database Cochrane
publications
G2 Included: Tinnitus, guidelines 2 review
Excluded:
Date: 31/05 2010- 31/05 2020

Database Cochrane
publications
G2 Included: Tinnitus, treatment 37 review
Excluded:
Date: 31/05 2010- 31/05 2020
Document location:
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The following papers were retrieved:

Tunkel et al. 2014. Clinical Included as a review for tinnitus PubMed
practice guideline: Tinnitus treatment options as well as
tinnitus management guideline
Cima et al. 2019. A Included as a review for tinnitus PubMed

multidisciplinary European treatment options as well as
guideline for tinnitus: diagnostics, tinnitus management guideline
assessment, and treatment and for general performance and
safety for treatment
Lewis et al. 2020. Assessment and Included as a review for tinnitus PubMed
management of tinnitus: treatment options
summary of NICE guidance
Ogawa et al. 2020. Clinical Included as a review for tinnitus PubMed
practice guidelines for diagnosis treatment options
and treatment of chronic tinnitus
in Japan
Hoare et al. 2011. Systematic Included as a review for tinnitus PubMed
Review and Meta-Analyses of treatment options
Randomized Controlled Trials
Examining Tinnitus Management
Fuller et al. 2017. Different Included as a review for tinnitus PubMed
Teams, Same Conclusions? treatment options as well as
Systematic Review of Existing tinnitus management guideline
Clinical Guidelines for the and for general performance and
Assessment and Treatment of safety for treatment
Tinnitus in Adults
Henry et al. 2019. Clinical Included as a review of tinnitus PubMed
Protocol to Promote management guideline
Standardization of Basic Tinnitus
Services by Audiologists.
Hobson J, Chisholm E, El Refaie A. Evidence of general performance Cochrane
(2012) Sound therapy (masking) and safety for treatment
in the management of tinnitus in
adults. Cochrane Database Syst
Rev. 2012 Nov 14;11
Fuller T, Cima R, Langguth B, Evidence of general performance Cochrane
Mazurek B, Vlaeyen JW, Hoare DJ and safety for treatment
(2020) Cognitive behavioural
therapy for tinnitus. Cochrane
Document location:
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Database Syst Rev. 2020 Jan

8;1(1):CD012614.
Appendix H: Data collection report for safety and performance endpoints
This section presents a literature search for data related to the clinical evaluation of wireless hearing aids.
The data is to be used for Clinical Evaluation of wireless hearing aids
of wireless hearing aids and implant accessories, when used as intended.
2. Clinical data that relate to state-of-the-art hearing aids to identify potential clinical hazards.
11.9.2 Data sources
Relevant articles and reports search in PubMed data base http://www.ncbi.nlm.nih.gov/pubmed/.

The rationale for the selection of PubMed:
• Well established and respected abstract and indexing data base.
• Comprises more than 19 million citations.
• Freely accessible online data base.
• Covers, for the relevant field, completely or partly other main biomedical data bases.
• PubMed search engine is an open source, i.e. ensuring transparency in search.
• Within the field of audiology, the number of journals is considerably.
Given the above-mentioned rationale it has also not been deemed necessary nor relevant to use
other databases than PubMed, i.e. PubMed is sufficient.


Population Adults older than 18 years Data to be used for clinical evaluation, thus only clinical
Children, 3-18 years data
Intervention/device Original clinical data on wireless air Data to be used for clinical evaluation, thus only clinical
conduction hearing aids. data. To ensure sufficient screening for safety-related
Document location:
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outcomes all versions/models of wireless hearing aids are
included.
Research using The device is specified, and the In general, studies on treatment with a specific wireless
specific devices fitting of the device is part of the state-of-the-art hearing aid are designed with a research
study hypothesis in mind that not is related to safety and
effectiveness of the device. The data on these treatments
will therefore not directly fulfill all the demands on
scientific relevance described in MEDDEV.2.7.1 v 4. On the
other hand, such treatment studies offer a very specific
information on intended use of the specific device. A good
practice in research would be to report of any drawbacks
using the device. The drawback of the limited amount of
data available, and the discrepancy in data quality with
MEDDEV.2.7.1 Rev 4, must be seen in the light of the
limited risks of the treatment and the benefits for the
patients.
Research on The device is unspecified as well as In general, studies on outcome and quality of life are often
satisfaction and the fitting of the device large scales studies with a range of different unspecified
quality of life wireless state-of-the-art hearing aids. The data on these
outcome studies will therefore not directly fulfill all the
demands on scientific relevance described in
MEDDEV.2.7.1 v 4. On the other hand, such studies safety
and effectiveness in the most valid way available within
this field. A good practice in research would be to report of
any drawbacks using the device. The drawback of the
limited amount of data available, and the discrepancy in
data quality with MEDDEV.2.7.1 Rev 4, must be seen in the
light of the limited risks of the treatment and the benefits
for the patients.
Outcome Safety and performance outcomes. Clinical data on safety and performance, as outlined in the
guideline
Study design Clinical investigations - all designs The number of studies is limited; therefore, all types of
and methodologies are included. studies are included. See rationale for comparison.
Time frame 30/6 2007 until 31/12 2018 (I) The time frame allows inclusion of data from
30/6 2007 until 31/5 2018 (A) versions/models that are relevant (equivalent in intended
use to devices under evaluation).
• Devices other than commercial wireless air conduction devices, i.e. no CI, BAHA or simulated hearing
aid
• Publications with audiological data, but not containing any data on the variables listed in 11.9.3 and
11.9.4.
• Review, thus no original clinical data.
• When the device is not used or fitted as intended. For example, when the device is used for
laboratory studies or when the device is not fitted with all features enabled.
• Not using SADL/IOI-HA for satisfaction studies.
Document location:
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11.9.5 Performance variables
• Gain and output when used as intended

• Speech perception when used as intended
• Quality of life: Measured as satisfaction with hearing aids thought two specific standardized
questionnaires Satisfaction with Amplification in Daily Life (SADL) and/or International Outcome
Inventory for Hearing Aids (IOI-HA)
• For children: also included: Language ability, aided audibility as well as parent-report PEACH and
LittleEars
11.9.6 Safety variables
• Adverse events related to the fitting of the device

• Adverse events related to the intended use of the device – e.g. pain caused by the earpiece,
loudness discomfort and skin reactions.
11.9.7 Search strategy and selection
The selection strategy comprised two selection phases: During the first selection (abstract screenning), four
different criteria were applied: population, device, review/surveys and language. Sometimes, abstract
information was not enough at this phase, so the specific information was collected through the full text of
the publication. The second selection was done after a light review of the full text of the publication. At first,
to sort out publication without commercial hearing aids. Letters to the editors, forwards, as well as review
articles were also excluded since they do not contain new data. Furthermore, laboratory studies, only using
the device for a few hours were excluded as well as studies using unspecified devices with a scope of
investigating audiological service and processes.
The search has been divided between adults, children and unilateral hearing loss. A total of 1279 publications
were retrieved in the search process. This first part of this literature search process was performed according
to Table 71. 312 publications did not fit within the inclusion criteria and were excluded after the abstract
review. 644 publications deemed to be within the acceptance criteria were obtained and read. 587
publications were deemed to be outside of acceptance criteria after reviewing the complete publication. The
remaining 58 publications are to be appraised and analyzed in the following. 35 contain data on adults and
23 on children.
Document location:
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Table 71: Search strategy for safety and performance

Date 20070630-20181231 (I); 20070630-20180531 (A)
Database PubMed

publications
A1 Included: Hearing aid and benefit, amplification, satisfaction 256
(Adults) Excluded: BAHA, Cochlea, Cros, Children, Tinnitus
Date: 20070630-20120629
((((((((("hearing aids"[MeSH Terms] OR ("hearing"[All Fields] AND "aids"[All

Fields]) OR "hearing aids"[All Fields] OR ("hearing"[All Fields] AND "aid"[All
Fields]) OR "hearing aid"[All Fields]) AND benefit[All Fields]) OR (("hearing
aids"[MeSH Terms] OR ("hearing"[All Fields] AND "aids"[All Fields]) OR "hearing
aids"[All Fields] OR ("hearing"[All Fields] AND "aid"[All Fields]) OR "hearing
aid"[All Fields]) AND ("personal satisfaction"[MeSH Terms] OR ("personal"[All
Fields] AND "satisfaction"[All Fields]) OR "personal satisfaction"[All Fields] OR
"satisfaction"[All Fields])) OR (("hearing aids"[MeSH Terms] OR ("hearing"[All
Fields] AND "aids"[All Fields]) OR "hearing aids"[All Fields] OR ("hearing"[All
Fields] AND "aid"[All Fields]) OR "hearing aid"[All Fields]) AND amplification[All
Fields])) NOT ("child"[MeSH Terms] OR "child"[All Fields] OR "children"[All
Fields])) NOT ("cochlea"[MeSH Terms] OR "cochlea"[All Fields] OR "cochlear"[All
Fields])) NOT ("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields])) NOT BAHA[All
Fields]) NOT anchored[All Fields]) NOT cros[All Fields]) AND
("2007/06/30"[PDAT] : "2012/06/29"[PDAT])
A2 Included: Hearing aid and benefit, amplification, satisfaction 640
(Adults) Excluded: BAHA, Cochlea, Cros, Children, Tinnitus
Date: 20120630-20200531
((((((((("hearing aids"[MeSH Terms] OR ("hearing"[All Fields] AND "aids"[All

Fields]) OR "hearing aids"[All Fields] OR ("hearing"[All Fields] AND "aid"[All
Fields]) OR "hearing aid"[All Fields]) AND benefit[All Fields]) OR (("hearing
aids"[MeSH Terms] OR ("hearing"[All Fields] AND "aids"[All Fields]) OR "hearing
aids"[All Fields] OR ("hearing"[All Fields] AND "aid"[All Fields]) OR "hearing
aid"[All Fields]) AND ("personal satisfaction"[MeSH Terms] OR ("personal"[All
Fields] AND "satisfaction"[All Fields]) OR "personal satisfaction"[All Fields] OR
"satisfaction"[All Fields])) OR (("hearing aids"[MeSH Terms] OR ("hearing"[All
Fields] AND "aids"[All Fields]) OR "hearing aids"[All Fields] OR ("hearing"[All
Fields] AND "aid"[All Fields]) OR "hearing aid"[All Fields]) AND amplification[All
Fields])) NOT ("child"[MeSH Terms] OR "child"[All Fields] OR "children"[All
Fields])) NOT ("cochlea"[MeSH Terms] OR "cochlea"[All Fields] OR "cochlear"[All
Fields])) NOT ("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields])) NOT BAHA[All
Fields]) NOT anchored[All Fields]) NOT cros[All Fields]) AND
("2012/06/30"[PDAT] : "2020/05/31"[PDAT])
A3 Included: Hearing aid and amplification, safety, PTS, TTS 22
(Adults) Excluded: None
Date: 20100801 - 20200816
((((((((("hearing aids"[MeSH Terms] OR ("hearing"[All Fields] AND
"aids"[All Fields])) OR "hearing aids"[All Fields]) AND
((("amplificate"[All Fields] OR "amplificates"[All Fields]) OR
"amplification"[All Fields]) OR "amplifications"[All Fields])) AND
(((("shift"[All Fields] OR "shifted"[All Fields]) OR "shifting"[All
Fields]) OR "shiftings"[All Fields]) OR "shifts"[All Fields])) AND
Document location:
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"PTS"[All Fields]) AND "TTS"[All Fields]) OR (("hearing"[MeSH

Terms] OR "hearing"[All Fields]) OR "hearings"[All Fields])) AND
((("acquired immunodeficiency syndrome"[MeSH Terms] OR
(("acquired"[All Fields] AND "immunodeficiency"[All Fields]) AND
"syndrome"[All Fields])) OR "acquired immunodeficiency
syndrome"[All Fields]) OR "aids"[All Fields])) AND (("safety"[MeSH
Terms] OR "safety"[All Fields]) OR "safeties"[All Fields])) AND
("risk"[MeSH Terms] OR "risk"[All Fields])
A4 Included: Hearing aid and performance, prediction, predictors, 54
Adults outcomes
Excluded: none
Date: 20100801-20200817
((((((("hearing aids"[MeSH Terms] OR ("hearing"[All Fields] AND
"aids"[All Fields])) OR "hearing aids"[All Fields]) OR ("hearing"[All
Fields] AND "aid"[All Fields])) OR "hearing aid"[All Fields]) AND
((((((((((((((("perform"[All Fields] OR "performable"[All Fields]) OR
"performance"[All Fields]) OR "performance s"[All Fields]) OR
"performances"[All Fields]) OR "performative"[All Fields]) OR
"performatively"[All Fields]) OR "performatives"[All Fields]) OR
"performativities"[All Fields]) OR "performativity"[All Fields]) OR
"performed"[All Fields]) OR "performer"[All Fields]) OR "performer
s"[All Fields]) OR "performers"[All Fields]) OR "performing"[All
Fields]) OR "performs"[All Fields])) AND ("outcome"[All Fields] OR
"outcomes"[All Fields])) AND ((((((((((((((("predict"[All Fields] OR
"predictabilities"[All Fields]) OR "predictability"[All Fields]) OR
"predictable"[All Fields]) OR "predictably"[All Fields]) OR
"predicted"[All Fields]) OR "predicting"[All Fields]) OR
"prediction"[All Fields]) OR "predictions"[All Fields]) OR
"predictive"[All Fields]) OR "predictively"[All Fields]) OR
"predictiveness"[All Fields]) OR "predictives"[All Fields]) OR
"predictivities"[All Fields]) OR "predictivity"[All Fields]) OR
"predicts"[All Fields])) AND ("predictor"[All Fields] OR
"predictors"[All Fields])
A5 Included: Hearing aid fitting and Quality of Life, self-assessment, spatial 107
Adults hearing, speech hearing,
Excluded: Cochlear Implant, BAHA, CROS
Date: 20200819 - 20000831
((((((((((((("hearing aids"[MeSH Terms] OR ("hearing"[All Fields]
AND "aids"[All Fields])) OR "hearing aids"[All Fields]) OR
("hearing"[All Fields] AND "aid"[All Fields])) OR "hearing aid"[All
Fields]) AND (((("fittings"[All Fields] OR "seizures"[MeSH Terms])
OR "seizures"[All Fields]) OR "fitted"[All Fields]) OR "fitting"[All
Fields])) AND "SSQ"[All Fields]) OR (("quality of life"[MeSH Terms]
OR ("quality"[All Fields] AND "life"[All Fields])) OR "quality of
life"[All Fields])) OR ((((((("impair"[All Fields] OR "impaired"[All
Fields]) OR "impairement"[All Fields]) OR "impairements"[All
Fields]) OR "impairing"[All Fields]) OR "impairment"[All Fields]) OR
"impairments"[All Fields]) OR "impairs"[All Fields])) AND
(((((("disabled persons"[MeSH Terms] OR ("disabled"[All Fields]
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AND "persons"[All Fields])) OR "disabled persons"[All Fields]) OR

"handicapped"[All Fields]) OR "handicap"[All Fields]) OR
"handicapping"[All Fields]) OR "handicaps"[All Fields])) AND
((((("spatial"[All Fields] OR "spatialization"[All Fields]) OR
"spatializations"[All Fields]) OR "spatialized"[All Fields]) OR
"spatially"[All Fields]) AND (("hearing"[MeSH Terms] OR
"hearing"[All Fields]) OR "hearings"[All Fields]))) NOT
("Cochelar"[All Fields] AND ((((((((((((((((((("embryo
implantation"[MeSH Terms] OR ("embryo"[All Fields] AND
"implantation"[All Fields])) OR "embryo implantation"[All Fields])
OR "implantation"[All Fields]) OR "implant"[All Fields]) OR "implant
s"[All Fields]) OR "implantability"[All Fields]) OR "implantable"[All
Fields]) OR "implantables"[All Fields]) OR "implantate"[All Fields])
OR "implantated"[All Fields]) OR "implantates"[All Fields]) OR
"implantations"[All Fields]) OR "implanted"[All Fields]) OR
"implanter"[All Fields]) OR "implanters"[All Fields]) OR
"implanting"[All Fields]) OR "implantion"[All Fields]) OR
"implantitis"[All Fields]) OR "implants"[All Fields]))) NOT "baha"[All
Fields]) NOT ((("chemically induced"[MeSH Subheading] OR
("chemically"[All Fields] AND "induced"[All Fields])) OR "chemically
induced"[All Fields]) OR "ci"[All Fields])) NOT "CROS"[All Fields]
A6 Included: APHAB 157
(Adults) Excluded: none
Date: 20000101-20200820
“APHAB” [All Fields]
C1 Included: Hearing aid and benefit, amplification, satisfaction. Children 60
(Children) Excluded: Search A1, BAHA, Cochlea, Cros, Tinnitus
Date: 20070630-20120629

"aids"[All Fields]) OR "hearing aids"[All Fields] OR ("hearing"[All Fields]
AND "aid"[All Fields]) OR "hearing aid"[All Fields]) AND benefit[All
Fields]) OR (("hearing aids"[MeSH Terms] OR ("hearing"[All Fields] AND
AND "aid"[All Fields]) OR "hearing aid"[All Fields]) AND ("personal
satisfaction"[MeSH Terms] OR ("personal"[All Fields] AND
"satisfaction"[All Fields]) OR "personal satisfaction"[All Fields] OR
"satisfaction"[All Fields])) OR (("hearing aids"[MeSH Terms] OR
("hearing"[All Fields] AND "aids"[All Fields]) OR "hearing aids"[All Fields]
OR ("hearing"[All Fields] AND "aid"[All Fields]) OR "hearing aid"[All
Fields]) AND amplification[All Fields])) NOT ("cochlea"[MeSH Terms] OR
"cochlea"[All Fields] OR "cochlear"[All Fields])) NOT ("tinnitus"[MeSH
Terms] OR "tinnitus"[All Fields])) NOT BAHA[All Fields]) NOT
anchored[All Fields]) NOT cros[All Fields]) AND ("2007/06/30"[PDAT] :
"2012/06/29"[PDAT])) NOT (((((((((("hearing aids"[MeSH Terms] OR
Fields]) AND benefit[All Fields]) OR (("hearing aids"[MeSH Terms] OR
Fields]) AND ("personal satisfaction"[MeSH Terms] OR ("personal"[All
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Fields] AND "satisfaction"[All Fields]) OR "personal satisfaction"[All

Fields] OR "satisfaction"[All Fields])) OR (("hearing aids"[MeSH Terms]
OR ("hearing"[All Fields] AND "aids"[All Fields]) OR "hearing aids"[All
Fields] OR ("hearing"[All Fields] AND "aid"[All Fields]) OR "hearing
aid"[All Fields]) AND amplification[All Fields])) NOT ("child"[MeSH
Terms] OR "child"[All Fields] OR "children"[All Fields])) NOT
("cochlea"[MeSH Terms] OR "cochlea"[All Fields] OR "cochlear"[All
Fields])) NOT ("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields])) NOT
BAHA[All Fields]) NOT anchored[All Fields]) NOT cros[All Fields]) AND
("2007/06/30"[PDAT] : "2012/06/29"[PDAT]))
C2 Included: Hearing aid and benefit, amplification, satisfaction. Children 153
(Children) Excluded: Search A2, BAHA, Cochlea, Cros, Tinnitus
Date: 20120630-20200531
Fields]) AND amplification[All Fields])) NOT ("cochlea"[MeSH Terms] OR
"cochlea"[All Fields] OR "cochlear"[All Fields])) NOT ("tinnitus"[MeSH
Terms] OR "tinnitus"[All Fields])) NOT BAHA[All Fields]) NOT
anchored[All Fields]) NOT cros[All Fields]) AND ("2012/06/30"[PDAT] :
"2020/05/31"[PDAT])) NOT (((((((((("hearing aids"[MeSH Terms] OR
Fields]) AND benefit[All Fields]) OR (("hearing aids"[MeSH Terms] OR
Fields]) AND ("personal satisfaction"[MeSH Terms] OR ("personal"[All
Fields] AND "satisfaction"[All Fields]) OR "personal satisfaction"[All
Fields] OR "satisfaction"[All Fields])) OR (("hearing aids"[MeSH Terms]
OR ("hearing"[All Fields] AND "aids"[All Fields]) OR "hearing aids"[All
Fields] OR ("hearing"[All Fields] AND "aid"[All Fields]) OR "hearing
aid"[All Fields]) AND amplification[All Fields])) NOT ("child"[MeSH
Terms] OR "child"[All Fields] OR "children"[All Fields])) NOT
("cochlea"[MeSH Terms] OR "cochlea"[All Fields] OR "cochlear"[All
Fields])) NOT ("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields])) NOT
BAHA[All Fields]) NOT anchored[All Fields]) NOT cros[All Fields]) AND
("2012/06/30"[PDAT] : "2020/05/31"[PDAT]))
C3 Included: Hearing aid and benefit, satisfaction, outcome. Children 218
(Children) Excluded: BAHA, Cochlea, Cros, Tinnitus
Date: 20070630-20200531
(((((((("hearing aids"[MeSH Terms] OR ("hearing"[All Fields] AND
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Fields]) AND outcome[All Fields]) AND ("child"[MeSH Terms] OR
"child"[All Fields] OR "children"[All Fields])) NOT ("cochlea"[MeSH
Terms] OR "cochlea"[All Fields] OR "cochlear"[All Fields])) NOT
("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields])) NOT BAHA[All
Fields]) NOT ("bone and bones"[MeSH Terms] OR ("bone"[All Fields]
AND "bones"[All Fields]) OR "bone and bones"[All Fields] OR "bone"[All
Fields])) NOT cros[All Fields]) AND ("2007/06/30"[PDAT] :
"2017/06/30"[PDAT])
C4 Included: Hearing aid and amplification, safety, PTS, TTS, Children 15
(Children) Excluded: None
Date: 20100801 - 20200816
(((((((((("hearing aids"[MeSH Terms] OR ("hearing"[All Fields] AND
"aids"[All Fields])) OR "hearing aids"[All Fields]) AND ((("amplificate"[All
Fields] OR "amplificates"[All Fields]) OR "amplification"[All Fields]) OR
"amplifications"[All Fields])) AND (((("shift"[All Fields] OR "shifted"[All
Fields]) OR "shifting"[All Fields]) OR "shiftings"[All Fields]) OR "shifts"[All
Fields])) AND "PTS"[All Fields]) AND "TTS"[All Fields]) OR
(("hearing"[MeSH Terms] OR "hearing"[All Fields]) OR "hearings"[All
Fields])) AND ((("acquired immunodeficiency syndrome"[MeSH Terms] OR
(("acquired"[All Fields] AND "immunodeficiency"[All Fields]) AND
"syndrome"[All Fields])) OR "acquired immunodeficiency syndrome"[All
Fields]) OR "aids"[All Fields])) AND (("safety"[MeSH Terms] OR "safety"[All
Fields]) OR "safeties"[All Fields])) AND ("risk"[MeSH Terms] OR "risk"[All
Fields])) AND (children) Filters: from 2010 - 2020
U1 Included: Hearing aid and benefit, amplification, satisfaction, monaural 85
(Unilateral) OR unilateral
Excluded: BAHA, Cochlea, Cros, Tinnitus
Date: 20070630-20200531
(((((((("hearing aids"[MeSH Terms] OR ("hearing"[All Fields] AND
Fields]) AND amplification[All Fields]) AND (monaural[All Fields] OR
unilateral[All Fields])) NOT ("cochlea"[MeSH Terms] OR "cochlea"[All
Fields] OR "cochlear"[All Fields])) NOT ("tinnitus"[MeSH Terms] OR
"tinnitus"[All Fields])) NOT ("bone and bones"[MeSH Terms] OR
("bone"[All Fields] AND "bones"[All Fields]) OR "bone and bones"[All
Fields] OR "bone"[All Fields])) NOT anchored[All Fields]) NOT cros[All
Fields]) AND ("2007/06/30"[PDAT] : "2020/05/31"[PDAT])
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11.9.8 Performance domains
The performance variable is applied within a broad performance domain that seem appropriate for the
clinical use of wireless hearing aids. These domains will be applied when appraising studies of clinical benefit.
Table 72: Overview of performance domain of the three performance variables used
# Domain Gain and output Speech Quality of life
(1) perception/language (3)
acquisition (2)
Hearing aid performance X X X
A compared to without
hearing aid
Hearing aid performance X X X
B compared another state-of-
the-art device
Hearing aid performance of X X X
C
a technical feature
11.9.9 Data appraisal
An overview of the literature search results is presented in

Figure 14 and Figure 15 for adults and children, respectively. Basically, the retrieved articles were assessed
for suitability and contribution though a scoring categorization shown in Table 73 and Table 74.
Table 73: Suitability assessment

Suitability Description Score Meaning
Criteria
Device Were the data generated from the actual device, 1 State-of-the-art wireless HA
Technology a device using similar technology or a device
2 Unspecified device
using other technology?
(D)
Application Was the device used for the same indication? 1 Same use
(A) 2 Minor deviation
3 Major deviation
Patient Group Were the data generated from a patient group 1 Applicable
that is representative of the intended
(P) 2 Limited
population?
3 Different population
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Study Size Did the study include a sufficient number of 1 N ≥ 20

patients to establish performance
(N) 2 8 < N < 20
characteristics?
3 N≤8
Table 74: Contribution assessment

Contribution Description Score Meaning
Criteria
Data type Was the design of the study appropriate? 1 Yes
(T) 2 No
Outcome Do the reported outcome measures support the use of the device 1 Yes
in clinical practice?
(O) 2 No
Statistics Were the statistics analysis adequately performed? 1 Yes
(S) 2 No
The individual scores were weighted according to the scheme shown in Table 75. This was done in order to
transform a score of 1, 2 or 3 from the suitability and contribution rating into a ratio weight between 0 and 1.
Table 75: Weighting scheme for suitability and contribution

Criterion Score X Relative Weight Formula Y(X)
Suitability 1 1,0 (3-X)/2
2 0,5
3 0,0
Contribution 1 1,0 (3-X)/2
2 0,5
By multiplying them all together (except outcome), the total contribution factor was calculated. The
compounded weight of each study (W) was calculated by multiplying all relative weights based on the
individual scores:
W = Y(D) * Y(A) * Y(P) * Y(N) * Y(T) * Y(S)
To prevent any bias against the exclusion of negative results, the outcome score was not factored into the
compounded weight calculation. The compounded weight (W) will be used as an indicator of the relative
importance of the findings from the articles under the data analysis in the next section.
An overview of the different compound weights is shown in Table 76 below. As seen in the last column, the
compounded weight (w) varies between 0.0625 to 1.
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Table 76: Overview of complete data appraisal

Reference Domai Group N Device D A P N T O S W
n
A1-72 B-1,2 Adults 23 Siemens 1 2 1 1 1 2 1 0.5
Artis 2 SP
A1-184 B-1 Adults 22 Siemens 1 1 1 1 1 1 1 1
Centra
Model S
A1-4 A-3 Adults 22 Unspecified 2 1 1 1 2 2 2 0.125
A2-25 C-2, 3 Adults 14 Phonak 1 1 1 2 1 1 2 0.25
Naida V SP
A2-188 C-2 Adults 12 Phonak 1 1 1 2 1 1 2 0.25
Naida V SP
A2-206 C-2 Adults 12 Phonak 1 1 1 2 1 1 1 0.5
Naida V SP
A2-222 C-1,2 Adults 13 Widex Clear 1 1 1 2 1 1 1 0.5
440
A2-39 A-3 Adults 91 Unknown 2 1 1 1 2 2 2 0.125
A2-64 A-2,3 Adults 65 Unknown 2 1 1 1 2 2 2 0.125
A2-280 A-1,2,3 Adults 160 Unknown 2 1 1 1 1 1 1 0.5
A2-467 B-1,2 Adults 60 Unknown 2 1 1 1 1 1 1 0.5
A2-484 B-1,2,3 Adults 54 Unknown 2 1 1 1 2 1 1 0.25
A2-505 B-1,2 Adults 24 Unknown 2 1 1 1 1 1 1 0.5
A2-513 A-2,3 Adults 26 Oticon Epoq 1 2 1 1 1 1 1
XW BTE 0.5
A2-514 C-2,3 Adults 40 Unknown 2 2 1 1 1 1 1
A2-525 0.25
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n
A2-517 C-2,3 Adults 22 Oticon 1 2 1 1 1 2 1
unknown
model 0.5
A3-01 C-1 Adults 234 No device N/A N/A N/A N/A 1 N/A 1 N/A
A4-01 A-2 Adults 68 Starkey X 1 1 1 1 1 1 1 1.0
RITE-style
A4-17 C-1 Adults 281 unknown 1 1 1 1 1 1 1 1.0
A4-25 B-2 Adults 234 unknown 2 2 1 1 1 1 1 0.25
A5-001 A-3 Adults 153 No device N/A N/A 1 1 1 1 1 N/A
A5-022 A-3 Adults N/A No device N/A N/A N/A N/A N/A N/A N/A N/A
A5-057 A-2 Adults 304 unknown 2 1 1 1 1 1 1 0.5
A6-14 A-3 Adults 154 WDRC HA 2 1 1 1 1 1 1 0.5
C1-23 C-2 Children 15 Phonak 1 1 1 2 1 1 1 0.5

Nios, BTE
C2-45 C-1,2 Children 11 Oticon 1 2 1 2 1 2 1 0.25
Safari 300,
Phonak Nios
S III
C2-48 C-2 Children 9 Oticon 1 1 2 2 1 1 1 0.25
Safari 300
Oticon
Safari 300,
Phonak Nios
S III
C2-8 A-3 Children 107 unknown 2 1 2 1 1 2 2 0.125
C2-107 NA Children 8 Phonak 1 1 1 3 1 2 1 0
Naida V90
SP/UP
C2-110 C-1,2 Children 166 Unknown 2 1 1 1 1 1 1 0.5
C2-112 C-2 Children 12 Unknown 2 1 1 2 1 1 1 0.25
C2-143 A-2 Children 60 Unknown 2 1 1 1 1 1 1 0.5
C3-43 B-2 Children 66 unknown 2 1 1 1 1 2 1 0.5
C3-47 A-1,2 Children 180 unknown 2 1 1 1 1 2 1 0.5
C3-53 B-1,2,3 Children 44 Phonak 1 1 1 1 1 1 1 1
Naida V
SP/UP
C3-80 B-1,2,3 Children 218 unknown 2 1 1 1 1 1 1 0.5
C3-95 B-1,2,3 Children 129 unknown 2 1 1 1 1 1 1 0.5
C3-215 A-2 Children 183 Unknown 2 1 1 1 2 1 1 0.25
C4-01 C-1 Children 213 unknown 2 2 1 1 1 1 1 0.25
U1-35 A-1,3 Adults 15 unknown 2 1 1 2 1 2 2 0.125

U1-38 A-3 Adults 224 unknown 2 1 1 1 1 2 1 0.5
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n
U1-50 B-2,3 Adults 214 unknown 2 1 1 1 1 1 1 0.5
U1-53 A-2,3 Adults 689 unknown 2 1 1 1 1 1 1 0.5
U1-77 B-2,3 Adults 62 Unknown 2 1 1 1 2 1 1 0.25
Table 77: Overview of data appraisal findings

Interpretation of finding Number of articles
Compelling (1) 1/0/1/0
Strong (0,50) 10/4/7/5
Fair (0,250) 10/3/1/1
Marginal (0,063-0,125) 16/1/0/1
None (0) 1/1/0/0
The overview has been divided between adults (A1&A2), children (C1&C2) children (C3) and unilateral (U1),
respectively, and is separated in the table with a forward slash “/”.
11.9.10 Review of publications
Each article was reviewed to extract the relevant clinical evidence, including the performance
characteristics, the contribution to clinical practice and any risk relating to the use of state-of-the
art wireless hearing aid. A complete review of all 71 publications is shown in Appendix J: Overview
of publications.
11.9.11 Critical evaluation of literature data
All the articles used as background for the clinical evaluation are critically evaluated in the following pages.
This critical evaluation includes an assessment of the quality of the data and its relevance for the devices
under evaluation, for mild to profound hearing losses, as well as the contribution of each data set to the
overall outcome of the evaluation.
As wireless hearing aids within the field of hearing aid fitting is a well-established technology and the safety
profile of the device is also well established as being a type of devices inducing a low number of adverse
events, the data evaluated is qualitatively rather than quantitatively in nature.
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Appendix I: Data collection report for safety and performance endpoints –

tinnitus sound therapy support
This document presents a literature search for data related to the clinical evaluation of wireless hearing aids.
The data is to be used for Clinical Evaluation of wireless hearing aids with tinnitus support
of wireless hearing aids with sound therapy support, when used as intended.
4. Clinical data that relate to state-of-the-art hearing aids with sound therapy support to
identify potential clinical hazards.
11.10.2 Literature collection
• Relevant articles and reports search in PubMed data base http://www.ncbi.nlm.nih.gov/pubmed/.

The rationale for the selection of PubMed:
 Well established and respected abstract and indexing data base.
 Comprises more than 19 million citations.
 Freely accessible online data base.
 Covers, for the relevant field, completely or partly other main biomedical data bases.
Given the above-mentioned rationale it has also not been deemed necessary nor relevant to use other
databases than PubMed, i.e. PubMed is sufficient.
The exclusion criteria are shown in Table 78 below.

clinical data
Intervention/device Original clinical data on wireless air Data to be used for clinical evaluation, thus only
conduction hearing aids with clinical data. To ensure sufficient screening for
tinnitus support (i.e. combination safety-related outcomes all versions/models of
instruments). wireless hearing aids are included.
Research using The device is specified, and the In general, studies on treatment with a specific
specific devices fitting of the device is part of the wireless state-of-the-art hearing aid are designed
study with a research hypothesis in mind that not is
related to safety and effectiveness of the device.
The data on these treatments will therefore not
directly fulfill all the demands on scientific
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relevance described in MEDDEV.2.7.1 v 4. On the
other hand, such treatment studies offer a very
specific information on intended use of the specific
device. A good practice in research would be to
report of any drawbacks using the device. The
drawback of the limited amount of data available,
and the discrepancy in data quality with
MEDDEV.2.7.1 Rev 4, must be seen in the light of
the limited risks of the treatment and the benefits
for the patients.
Research on The device is unspecified as well as In general, studies on outcome and quality of life
satisfaction and the fitting of the device are often large scales studies with a range of
quality of life different unspecified wireless state-of-the-art
hearing aids. The data on these outcome studies
will therefore not directly fulfill all the demands on
scientific relevance described in MEDDEV.2.7.1 v 4.
On the other hand, such studies safety and
effectiveness in the most valid way available within
this field. A good practice in research would be to
report of any drawbacks using the device. The
drawback of the limited amount of data available,
and the discrepancy in data quality with
MEDDEV.2.7.1 Rev 4, must be seen in the light of
the limited risks of the treatment and the benefits
for the patients.
in the guideline
Study design Clinical investigations - all designs The number of studies is limited; therefore, all
and methodologies are included. types of studies are included. See rationale for
comparison.
Table 78. Exclusion criteria
• Devices other than commercial combination instruments, i.e. no CI, BAHA or simulated hearing aid or
masker
• Publications with audiological data, but not containing any data on the variables listed in 11.10.2.4
and 11.10.2.5.
• Review or comments, thus no original clinical data.
• When the device is not used or fitted as intended. For example, when the device is used for
laboratory studies only or when used as part of an overall audiological or therapeutic service without
interest in audiological benefit or relief of tinnitus.
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11.10.2.4 Performance variables
• Relief of tinnitus when used as intended Tinnitus Handicap Inventory (THI), Tinnitus Functional Index
(TFI) or Tinnitus Reaction Questionnaire (TRQ)
• Sound quality of tinnitus masking sound. For example, pleasantness or listening comfort.
11.10.2.5 Safety variables
• Adverse events related to the fitting of the tinnitus sounds module

• Adverse events related to the intended use of the tinnitus module per se. – e.g. pain or discomfort
caused by loudness discomfort of masking sound.
• Adverse events related to the intended use of the hearing aid itself – e.g. pain caused by the
earpiece, loudness discomfort of amplified sound and skin reactions, are covered by the clinical
evaluation of the wireless hearing aid.
11.10.3 PubMed Search strategy and selection
The selection strategy comprised two selection phases
During the first selection (abstract scanning) different criteria were effectuated: population, device,
review/surveys and language, see section 11.10.2.2 and 11.10.2.3. Sometimes, abstract information was not
enough at this phase, so the specific information was collected through the full text of the publication.
The second selection was done after a light review of the full text of the publication. Laboratory studies, only
using the device for a few hours were excluded as well as studies using unspecified devices with a scope of
investigating audiological service and processes. see 11.10.2.2 and 11.10.2.3.
The search has been limited to adults with hearing loss using combination instruments. An overview of the
literature search process is shown in Figure 17. 198 publications were retrieved in the search process. This
first part of this literature search process was performed according to Table 79. 145 publications did not fit
within the inclusion criteria and were excluded after the abstract review. 53 publications deemed to be
within the acceptance criteria were obtained and read.
44 publications were deemed to be outside of acceptance criteria after reviewing the complete publication.
The remaining 8 publications are to be appraised and analyzed in the following.
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Date 20080630-20200630
Database PubMed
publications
A1 Included: Tinnitus treatment, masking 161
Excluded: N/A
Date: 20080630-20200630
(("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields]) AND
(((((("therapeutics"[MeSH Terms] OR "therapeutics"[All Fields]) OR
"treatments"[All Fields]) OR "therapy"[MeSH Subheading]) OR
"therapy"[All Fields]) OR "treatment"[All Fields]) OR "treatment s"[All
Fields]) AND (((("mask s"[All Fields] OR "masked"[All Fields]) OR
"masking"[All Fields]) OR "masks"[MeSH Terms]) OR "masks"[All Fields]))
AND 2008/6/30:2020/6/30[Date - Publication]
A2 Included: Tinnitus retraining therapy 75
Excluded: A1
Date: 20080630-20200630
((("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields]) AND (((("retrain"[All
Fields] OR "retrained"[All Fields]) OR "retraining"[All Fields]) OR
"retrainings"[All Fields]) OR "retrains"[All Fields]) AND
(((((("therapeutics"[MeSH Terms] OR "therapeutics"[All Fields]) OR
"therapies"[All Fields]) OR "therapy"[MeSH Subheading]) OR "therapy"[All
Fields]) OR "therapy s"[All Fields]) OR "therapys"[All Fields])) AND
2008/6/30:2020/6/30[Date - Publication]) NOT ((("tinnitus"[MeSH Terms]
OR "tinnitus"[All Fields]) AND (((((("therapeutics"[MeSH Terms] OR
"treatment"[All Fields]) OR "treatment s"[All Fields]) AND (((("mask s"[All
Fields] OR "masked"[All Fields]) OR "masking"[All Fields]) OR
"masks"[MeSH Terms]) OR "masks"[All Fields])) AND
2008/6/30:2020/6/30[Date - Publication])
A3 Included: Tinnitus, Combination instrument, Combination hearing aid, 123
combination device, integrated sound generator
Excluded: A1, A2
Date: 20080630-20200630
((((("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields]) AND
((((((((((((("combinable"[All Fields] OR "combinated"[All Fields]) OR
"combination"[All Fields]) OR "combinational"[All Fields]) OR
"combinations"[All Fields]) OR "combinative"[All Fields]) OR
"combine"[All Fields]) OR "combined"[All Fields]) OR "combines"[All
Fields]) OR "combining"[All Fields]) AND (((((("instrument"[All Fields] OR
"instrument s"[All Fields]) OR "instrumentation"[MeSH Subheading]) OR
"instrumentation"[All Fields]) OR "instruments"[All Fields]) OR
"instrumented"[All Fields]) OR "instrumenting"[All Fields])) OR
(((((((((("combinable"[All Fields] OR "combinated"[All Fields]) OR
"combination"[All Fields]) OR "combinational"[All Fields]) OR
Fields]) OR "combining"[All Fields]) AND (((("hearing aids"[MeSH Terms]
OR ("hearing"[All Fields] AND "aids"[All Fields])) OR "hearing aids"[All
Fields]) OR ("hearing"[All Fields] AND "aid"[All Fields])) OR "hearing
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aid"[All Fields]))) OR (((((((((("combinable"[All Fields] OR "combinated"[All

Fields]) OR "combination"[All Fields]) OR "combinational"[All Fields]) OR
Fields]) OR "combining"[All Fields]) AND ((((((("device s"[All Fields] OR
"equipment and supplies"[MeSH Terms]) OR ("equipment"[All Fields]
AND "supplies"[All Fields])) OR "equipment and supplies"[All Fields]) OR
"device"[All Fields]) OR "instrumentation"[MeSH Subheading]) OR
"instrumentation"[All Fields]) OR "devices"[All Fields]))) OR
(((((((((((((((((("integrability"[All Fields] OR "integrable"[All Fields]) OR
"integral"[All Fields]) OR "integrally"[All Fields]) OR "integrals"[All Fields])
OR "integrant"[All Fields]) OR "integrants"[All Fields]) OR "integrate"[All
Fields]) OR "integrated"[All Fields]) OR "integrates"[All Fields]) OR
"integrating"[All Fields]) OR "integration"[All Fields]) OR
"integrational"[All Fields]) OR "integrations"[All Fields]) OR
"integrative"[All Fields]) OR "integratively"[All Fields]) OR "integrator"[All
Fields]) OR "integrators"[All Fields]) AND (((((("sound"[MeSH Terms] OR
"sound"[All Fields]) OR "sounded"[All Fields]) OR "soundings"[All Fields])
OR "sounds"[All Fields]) OR "sound s"[All Fields]) OR "sounding"[All
Fields]) AND ((((((((((((((((((((((((((((((((((((((((((((((((("drugs, generic"[MeSH
Terms] OR ("drugs"[All Fields] AND "generic"[All Fields])) OR "generic
drugs"[All Fields]) OR "generic"[All Fields]) OR "family
characteristics"[MeSH Terms]) OR ("family"[All Fields] AND
"characteristics"[All Fields])) OR "family characteristics"[All Fields]) OR
"generation"[All Fields]) OR "generations"[All Fields]) OR "general"[All
Fields]) OR "general s"[All Fields]) OR "generalisability"[All Fields]) OR
"generalisable"[All Fields]) OR "generalisation"[All Fields]) OR
"generalization, psychological"[MeSH Terms]) OR ("generalization"[All
Fields] AND "psychological"[All Fields])) OR "psychological
generalization"[All Fields]) OR "generalization"[All Fields]) OR
"generalisations"[All Fields]) OR "generalise"[All Fields]) OR
"generalised"[All Fields]) OR "generalises"[All Fields]) OR
"generalisibility"[All Fields]) OR "generalising"[All Fields]) OR
"generalities"[All Fields]) OR "generality"[All Fields]) OR
"generalizability"[All Fields]) OR "generalizable"[All Fields]) OR
"generalizations"[All Fields]) OR "generalize"[All Fields]) OR
"generalized"[All Fields]) OR "generalizes"[All Fields]) OR
"generalizing"[All Fields]) OR "generally"[All Fields]) OR "generals"[All
Fields]) OR "generate"[All Fields]) OR "generated"[All Fields]) OR
"generates"[All Fields]) OR "generating"[All Fields]) OR "generation s"[All
Fields]) OR "generational"[All Fields]) OR "generative"[All Fields]) OR
"generatively"[All Fields]) OR "generativity"[All Fields]) OR "generator"[All
Fields]) OR "generator s"[All Fields]) OR "generators"[All Fields]) OR
"generically"[All Fields]) OR "genericity"[All Fields]) OR "generics"[All
Fields])))) AND 2008/6/30:2020/6/30[Date - Publication]) NOT
(("tinnitus"[MeSH Terms] OR "tinnitus"[All Fields]) AND (((("mask s"[All
"masks"[MeSH Terms]) OR "masks"[All Fields]))) AND
2008/6/30:2020/6/30[Date - Publication]) NOT ((("tinnitus"[MeSH Terms]
OR "tinnitus"[All Fields]) AND (((((("therapeutics"[MeSH Terms] OR
"treatment"[All Fields]) OR "treatment s"[All Fields]) AND (((("mask s"[All
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"masks"[MeSH Terms]) OR "masks"[All Fields])) AND
2008/6/30:2020/6/30[Date - Publication])
Table 79 Summary of keywords and search results (PubMed)
11.10.4 Data appraisal
The 10 retrieved articles for adults with hearing loss using sound therapy support were assessed for
suitability and contribution through a scoring categorization shown in Table 80 and Table 81 below.
Suitability Description Score Meaning

Criteria
Device Were the data generated from the actual device, a 1 State-of-the-art wireless HA
Technology device using similar technology or a device using
other technology? 2 Unspecified device
(D)
Application Was the device used for the same indication? 1 Same use
(A) 2 Minor deviation
3 Major deviation
Patient Group Were the data generated from a patient group that 1 Applicable
is representative of the intended population?
(P) 2 Limited
3 Different population
Study Size Did the study include a sufficient number of 1 N ≥ 20

patients to establish performance characteristics?
(N) 2 7 < N < 20
3 N≤7
Table 80. Suitability evaluation (Best = 1 worst =3)
Contribution Description Score Meaning

Criteria
Data type Was the design of the study appropriate? 1 Yes
(T) 2 No
Outcome Do the reported outcome measures support the use of the device 1 Yes
in clinical practice?
(O) 2 No
Figure 17 Overview of literature search results. The search has been divided into three searches (A1, A2 and A3) and is
separated in the figure with a forward slash “/”.
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Statistics Were the statistics analysis adequately performed? 1 Yes
(S) 2 No
Table 81. Contribution evaluation (Best = 1 worst =2)
The individual scores were weighted according to the scheme shown in
Table 82. This was done in order to transform a score of 1, 2 or 3 from the suitability and contribution rating
into a ratio weight between 0 and 1.
Table 82. Weighting scheme for suitability and contribution

Criterion Score X Relative Weight Formula Y(X)
Suitability 1 1.0 (3-X)/2
2 0.5
3 0.0
Contribution 1 1.0 (3-X)/2
2 0.5
By multiplying them all together (except outcome), the total contribution factor was calculated. The
compounded weight of each study (W) was calculated by multiplying all relative weights based on the
individual scores:
W = Y(D) * Y(A) * Y(P) * Y(N) * Y(T) * Y(S)
To prevent any bias against the exclusion of negative results, the outcome score was not factored into the
compounded weight calculation. The compounded weight (W) will be used as an indicator of the relative
importance of the findings from the articles under the data analysis in the next section.
As seen in the last column of
Table 82, the compounded weight (w) varies between 0,0625 to 1. An overview of the different compound
weights is shown in Table 83 below.
Table 83. Overview of complete data appraisal

Reference Group N Device D A P N T O S W
A1-13 Adult 8 Oticon Alta 1 1 1 2 2 2 2 0.125
Ti (pre-
market)
A1-16 Adult 34 Unknown 2 1 1 2 1 1 1 0.25
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Reference Group N Device D A P N T O S W

A1-95 Adult 14 Widex 1 1 2 2 2 1 1 0.125
Mind 440
A1-100 Adult 33 Unknown 2 1 2 1 2 2 2 0.0625
A1-154 Adult 40 Siemens 1 2 1 1 2 2 2 0.125
Life 501
A2-3 Adult 20 Alta2 Pro 1 2 2 1 1 2 1 0.25
Ti
A2-8 Adult 38 Resound 1 1 1 1 1 1 1 1
Live 9 TS
A3-6 Adult 37 Phonak 1 1 1 1 1 1 1 1
Audeo
A3-12 Adult 30 Unknown 2 1 1 1 1 1 1 0.5
A3-13 Adult 49 Unknown 2 1 1 1 1 2 1 0.5
Table 84. Overview of the 10 findings from the data appraisal.

Interpretation of finding Number of articles
Compelling (1) 2
Strong (0,50) 2
Fair (0,250) 2
Marginal (0,063-0,125) 4
None (0) 0
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Appendix J: Overview of publications
11.11.1 Wireless hearing aids
Reference # A1-72,
Convery E, Keidser G. Transitioning hearing aid users with severe and profound loss to a new
gain/frequency response: benefit, perception, and acceptance. J Am Acad Audiol. 2011 Mar;22(3):168-80.
1) Objective The study investigated the effect of a gradual change in gain/frequency response on
experienced hearing-aid wearers with moderately severe to profound hearing loss.
2) Population 23 listeners with hearing impairment average age of 64 (ranging from 22 to 86 y)
3) Performance The results of the study showed that participants in the experimental group were subjectively
accepting of the changes to their amplification characteristics, as evidenced by nonsignificant
changes in the ratings of device performance over time. Perception of loudness, sound
quality, speech intelligibility, and own voice volume did not change significantly throughout
the study.
4) Risk (safety) E.g., no risk identified in the use of this device (or state risk and the mitigation to resolve the
risk in risk analysis)
5) Conclusion As seen in Table 76 above, compounded weight W for the study was 0,5. In other words,
there is a strong positive contribution for the indication
Render evidence for performance:

It has great value in relation to hearing aid performance that even when gain changes
gradually during an update of the hearing aid for severe hearing-impaired user they can still
utilize the new gain within very short time.
Reference A1-184,
Mueller HG, Hornsby BW, Weber JE. Using trainable hearing aids to examine real-world preferred gain. J Am Acad
Audiol. 2008 Nov-Dec;19(10):758-73.
1) Objective To determine whether real-world preferred hearing aid gain with trainable modern hearing
aids is in agreement with previous work in this area, and to determine whether the starting
programmed gain setting influences preferred gain outcome.
2) Population 22 listeners with hearing impairment, average age of 65 (ranging from 24 to 83 y)
3) Performance When trainable hearing aids are used, the initial programmed gain of hearing instruments
can influence preferred gain in the real world.
4) Risk (safety) E.g. no risk identified in the use of this device (or state risk and the mitigation to resolve the
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there is a compelling positive contribution for the indication

The study shows that the users benefit from the hearing aids, can be improved once they are
allowed to adapt the gain for their needs in real life.
Reference C1-23
Wolfe J, John A, Schafer E, Nyffeler M, Boretzki M, Caraway T. Evaluation of nonlinear frequency compression for
school-age children with moderate to moderately severe hearing loss. J Am Acad Audiol. 2010 Nov-Dec;21(10):618-
28
1) Objective To evaluate nonlinear frequency compression (NLFC) as a means to improve speech
recognition for children with moderate to moderately severe hearing loss.
2) Population 15 listeners with hearing impairment, average age of 10,4 (ranging from 6 to 12 y)
3) Performance These results indicate that NLFC improves audibility for and recognition of high-frequency
speech sounds for children with moderate to moderately severe hearing loss in quiet listening
situations.

The study shows, that the children with moderate to moderately severe hearing loss can
benefit from the use of frequency compression and thereby increase audibility of weak speech
sounds.
Reference A2-222
Lau CC, Kuk F, Keenan D, Schumacher J. Amplification for listeners with a moderately severe high-frequency hearing
loss. J Am Acad Audiol. 2014 Jun;25(6):562-75.
1) Objective The efficacy of three amplification options related to frequency content were evaluated for
listeners with a moderately severe, high-frequency hearing loss.
3) Performance The results supported the fitting of an extended bandwidth as the better choice for this group
of listeners.
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The study shows, that the moderate to severe users have the choice of different frequency
responses they tend to prefer the extended bandwidth over a frequency transposed one.
Reference A2-188
Ellis RJ, Munro KJ. Predictors of aided speech recognition, with and without frequency compression, in older adults.
Int J Audiol. 2015 Jul;54(7):467-75.
1) Objective The aim was to investigate whether cognitive and/or audiological measures predict aided
speech recognition, both with and without frequency compression (FC).
2) Population 12 listeners with hearing impairment, average age of 75,5 (ranging from 64 to 84)
3) Performance The strongest predictor of aided speech recognition, both with and without FC, was high
frequency hearing loss. Cognitive performance was also a predictor of benefit from
conventional amplification, but not of additional benefit from the use of FC.
there is a fair positive contribution for the indication
The study shows, that a simple test which only takes only minutes to administer, could be a
practical option to administer in a clinical setting instead of more time consuming speech
testing.
Reference A2-206
Ellis RJ, Munro KJ. Benefit from, and acclimatization to, frequency compression hearing aids in experienced
adult hearing-aid users. Int J Audiol. 2015 Jan;54(1):37-47
1) Objective The aim was to investigate whether frequency compression (FC) hearing aids provide
additional benefit to that conferred by conventional amplification.
3) Performance FC may lead to significant improvements in speech perception outcomes in both quiet and
noise for many individuals. No participant was significantly disadvantaged by the use of FC.
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The study shows that the users with moderate-to-severe high-frequency hearing loss can
show benefit of frequency compression in a laboratory speech test but not in a real life
setting.
Reference A2-25
Tseng WH, Hsieh DL, Shih WT, Liu TC. Extended bandwidth nonlinear frequency compression in Mandarin-speaking
hearing-aid users. J Formos Med Assoc. 2017 Apr 6
1) Objective The purpose of this study was to explore the effects of nonlinear frequency compression
(NLFC) and extended bandwidth (EB) NLFC on Mandarin word recognition in patients with
high frequency hearing loss.
2) Population 14 listeners with hearing impairment, average age of 44 (ranging from 20 to 65)
3) Performance Patients with high-frequency hearing loss may benefit more from using EB-NLFC for word and
consonant recognition; however, the improvement was small under a noisy listening
environment. The subjective questionnaires did not show significant benefit of EB-NLFC
either.
there is a fair positive contribution for the indication.
The study shows that the users with high frequency hearing loss can benefit from frequency
compression in a laboratory speech test but not in a real life setting.
Reference A2-39
Kozlowski L, Ribas A, Almeida G, Luz I. Satisfaction of Elderly Hearing Aid Users. Int Arch Otorhinolaryngol. 2017
Jan;21(1):92-96
1) Objective To evaluate the level of user satisfaction with hearing aids among elderly subjects with
hearing loss.
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3) Performance This study demonstrates a high degree of satisfaction with the hearing aids for the majority
of the sample collected, increasing with time of use and a greater degree of hearing loss.
there is only a marginal contribution for the indication.
The study shows, that the users tend to have more satisfaction with hearing aid if they use it
regularly and if their hearing loss is large.
Reference A2-65
Faraji-Khiavi F, Dashti R, Sameni SJ, Bayat A. Satisfaction with Hearing Aids Based on Technology and Style among
Hearing Impaired Persons. Iran J Otorhinolaryngol. 2016 Sep;28(88)
1) Objective To assess satisfaction of hearing impaired patients with their hearing aids regarding the
employed technology and style.
2) Population 187 listeners with hearing impairment (ranging from 18 to 90 y)
3) Performance Respondents using hearing aids with different technology and style were estimated to be
quite satisfied.
there is only a marginal contribution for the indication
The study shows, that the users shows higher degree of satisfaction using modern digital
technology.
Reference A2-138
Kelly-Campbell RJ, McMillan A. The Relationship Between Hearing Aid Self-Efficacy and Hearing Aid Satisfaction. Am
J Audiol. 2015 Dec;24(4):529-35
1) Objective The purpose of this study was to investigate the relationship between self-efficacy for
hearing aids (HAs) and satisfaction with HAs in a group of adult HA owners.
3) Performance Many HA owners do not have adequate self-efficacy in important HA-related domains.
Clinical intervention to improve self-efficacy for HAs may help improve HA satisfaction.
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The study shows that the users can improve their hearing aid satisfaction if they perform self-
efficiency tasks like the ability to follow speech, to handling the HA, to get use to the HA and
troubleshooting tasks.
Reference A2-174
Kozlowski L, Almeida G, Ribas A. Level of user satisfaction with hearing AIDS and environment: the international
outcome inventory for hearing AIDS. Int Arch Otorhinolaryngol. 2014 Jul;18(3):229-34
1) Objective To evaluate the level of user satisfaction with hearing aids.
3) Performance The results of the study shows a high degree of satisfaction with hearing aids for the majority
of the participants, which improved the quality of life.
The study shows, that hearing aids able to help the end user reenter contact with society,
because, in the process of aging, hearing loss, among sensory deprivation, produces the
greatest impact on communication of the elderly which can lead to isolation.
Reference A2-291
Dell'Antônia SF, Ikino CM, Carreirão Filho W. Degree of satisfaction of patients fitted with hearing aids at a high
complexity service. Braz J Otorhinolaryngol. 2013 Sep-Oct;79(5):555-63
1) Objective To assess the degree of satisfaction of patients fitted with hearing aids.
3) Performance Patients were generally very satisfied with their hearing aids. Satisfaction rates were higher
among patients fitted with in-the-ear hearing aids. Lesser degrees of satisfaction were seen
in patients with sensorineural and profound hearing loss.
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The study shows, that hearing aid satisfaction can be quite high and be influenced of the
choice of style and hearing loss.
Reference A2-292
Silva DP, Silva VB, Aurélio FS. Auditory satisfaction of patients fitted with hearing aids in the Brazilian Public Health
Service and benefits offered by the hearing aids. Braz J Otorhinolaryngol. 2013 Sep-Oct;79(5):538-45.
1) Objective To assess the benefits and degree of satisfaction of adult and elderly patients fitted with
hearing aids in a service accredited by the Brazilian Public Health Service.
2) Population 34 listeners with hearing impairment, average age of 42/72y
3) Performance The subjects included in the study had benefit from hearing aids and was satisfied with the
outcome of the treatment.
The study shows, that the users that were offered hearing aids, had significant reductions in
the difficulties they experienced as a consequence of hearing loss.
Reference A2-356
Aurélio FS, Silva SP, Rodrigues LB, Kuniyoshi IC, Botelho MS. Satisfaction of patients fit with a hearing aid in a high
complexity clinic. Braz J Otorhinolaryngol. 2012 Oct;78(5):69-77.
1) Objective To check the satisfaction of adults and elderly patients concerning their hearing aid in a high
complex care clinic accredited by the Unified Health System, and to correlate this outcome
with the variables related to age, gender, fitting period, daily use, as well as the type of sound
amplifying device.
3) Performance It was found that the subjects of the study were very happy with the use of hearing aids,
although satisfaction was not related to the variables: age, gender, time of use and device
type. In general, participants with higher daily use are happier.
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The study shows, that the users shows more satisfaction with hearing aids if they are worn
many hours a day
Reference A2-64
Mantello EB, Silva CD, Massuda ET, Hyppolito MA, Reis AC. Relationship between Speech Perception and Level of
Satisfaction of Hearing Aid Users. Int Arch Otorhinolaryngol. 2016 Oct;20(4):315-320.
1) Objective To assess the speech perception and satisfaction of hearing aids users before and after aid
adaptation and to determine whether these measures are correlated.
3) Performance Speech recognition was significantly better with the use of the hearing aids. The users showed a
high degree of satisfaction. No correlation observed between speech perception and user
satisfaction measured with the questionnaire.
4) Risk (safety) E.g. no risk identified in the use of this device (or state risk and the mitigation to resolve the risk
in risk analysis)
The study shows, that the users showed high satisfaction with hearing aids but it could not be
predicted with speech tests.
Reference A2-66
Thorup N, Santurette S, Jørgensen S, Kjærbøl E, Dau T, Friis M. Auditory profiling and hearing-aid satisfaction in
hearing-aid candidates. Dan Med J. 2016 Oct;63(10)
1) Objective This study aimed at identifying clinically relevant tests that may serve as an informative addition
to the audiogram and which may relate more directly to HA satisfaction than the audiogram
does.
3) Performance HI listeners have difficulties in different hearing domains that are not predictable from their
audiogram. Measures of temporal resolution or speech perception in both stationary and
fluctuating noise could be relevant measures to consider in an extended auditory profile.
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in risk analysis)
The study shows that the users, who had a more limited intelligibility advantage from
fluctuations in the background noise, experienced greater HA satisfaction. Neither hearing
thresholds nor other test outcomes were correlated with HA satisfaction.
Reference A2-169
Kayabaşoğlu G, Kaymaz R, Erkorkmaz Ü, Güven M. Study of hearing aid effectiveness and patient satisfaction. Kulak
Burun Bogaz Ihtis Derg. 2015;25(3):158-62.
1) Objective This study aims to investigate hearing aid using rate, patient satisfaction rate and achievements
in social communication of patients by assessing the hearing thresholds before and after device
use in patients who were determined as suitable for hearing aid use.
2) Population 47 listeners with hearing impairment
3) Performance Using hearing aid affects daily activities of patients slightly or moderately and increases their
communication skills. 72% benefited significantly from hearing aid compared to the before-
hearing aid period.
in risk analysis)
The study shows, that the users satisfaction rate were significantly higher with hearing aid than
without .
Reference A2-249
Brännström KJ, Lantz J, Nielsen LH Olsen SØ. Prediction of IOI-HA scores using speech reception thresholds and speech
discrimination scores in quiet. J Am Acad Audiol. 2014 Feb;25(2):154-63.
1) Objective The aim of the present study was to investigate the relationship between pure-tone average
(PTA), speech reception thresholds (SRTs), and speech discrimination scores (SDS) in quiet and
IOI-HA in both first-time and experienced HA users.
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3) Performance The best ears SDS explains some of the variance displayed in the IOI-HA global score and the
interaction subscale. The relation between SDS and IOI-HA suggests that a poor unaided SDS
might in itself be a limiting factor for the HA rehabilitation efficacy and hence the IOI-HA
outcome.
in risk analysis)
5) Conclusion As seen in Table 76 above, compounded weight W for the study was 0,5. In other words, there
is a strong positive contribution for the indication
The study shows, that the users of poor speech discrimination scores also experience poor
hearing aid satisfaction
Reference A2-278
Iwahashi JH, Jardim Ide S, Bento RF. Results of hearing aids use dispensed by a publicly-funded health service. Braz J
Otorhinolaryngol. 2013 Nov-Dec;79(6):681-7.
1) Objective Evaluate hearing aid use dispensed in a publicly-funded health service after one year, the
interventions needed and users' satisfaction.
2) Population 200 listeners with hearing impairment, average age of 71
3) Performance Active search by telephone showed that hearing aid users who attend this publicly-funded
health service have difficulties to attend follow-up appointments. Most of the users that came
for evaluation kept using their hearing aids. Most of the users (98%) were satisfied with
amplification
in risk analysis)
there is only marginal contribution for the indication
The study shows, that the users, despite high degree of satisfaction still are in need of follow up
appointments
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Reference A2-280
Hickson L, Meyer C, Lovelock K, Lampert M, Khan A. Factors associated with success with hearing aids in older adults.
Int J Audiol. 2014 Feb;53 Suppl 1:S18-27
1) Objective To examine associations between audiological and non-audiological factors and successful
hearing aid use in older adults.
3) Performance Non-audiological factors contribute significantly to hearing aid satisfaction: greater support from significant
others; more difficulties with hearing and communication in everyday life before getting hearing aids; more
positive attitudes to hearing aids; coupled with greater perceived self-efficacy for advanced handling of
hearing aids; or who were receiving more gain from their devices.
in risk analysis)
The study highlight the importance of addressing non-audiological factors in order to assist older
adults achieve satisfaction with hearing aids.
Reference C2-45
Wolfe J, John A, Schafer E, Hudson M, Boretzki M, Scollie S, Woods W, Wheeler. J, Hudgens K, Neumann S. Evaluation
of wideband frequency responses and non-linear frequency compression for children with mild to moderate high-
frequency hearing loss. Int J Audiol. 2015 Mar;54(3):170-81
1) Objective To evaluate wideband amplification and non-linear frequency compression (NLFC) as a means to
improve speech recognition for children with mild/moderate hearing loss.
3) Performance Children with mild to moderate hearing loss have similar sentence recognition with both wideband and
NLFC technology. Small but significant improvements was seen in the detection and recognition of the
phonemes /s/ and /sh/ with NLFC condition when compared to the NLFC Off and wideband conditions.
in risk analysis)
is a fair positive contribution for the indication
The study shows, that the users benefit with frequency compression was limited to specific
phonemes.
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Reference C2-48
John A, Wolfe J, Scollie S, Schafer E, Hudson M, Woods W, Wheeler J, Hudgens K, Neumann S. Evaluation of wideband
frequency responses and nonlinear frequency compression for children with cookie-bite audiometric configurations. J
Am Acad Audiol. 2014 Nov-Dec;25(10):1022-33
1) Objective The purpose of this study was to evaluate and compare the effects of wideband amplification
and nonlinear frequency compression (NLFC) on high-frequency audibility and speech
recognition of children with cookie-bite audiometric configurations.
2) Population 9 listeners with hearing impairment, average age of 10,4 (ranging from 9,8 to 11,5 y)
3) Performance These results suggest that NLFC does not degrade or improve audibility for and recognition of high-
frequency speech sounds as well as sentence recognition in noise when compared with wideband
amplification for children with cookie-bite audiometric configurations.
in risk analysis)
The study shows, that the users of frequency compression do not show either improving or
degrading speech perception compared to full bandwidth amplification
Reference C2-31
Walker EA, McCreery RW, Spratford M, Oleson JJ, Van Buren J, Bentler R, Roush P, Moeller MP. Trends and Predictors
of Longitudinal Hearing Aid Use for Children Who Are Hard of Hearing. Ear Hear. 2015 Nov-Dec;36 Suppl 1:38S-47S
1) Objective The purpose of this article was to characterize long-term HA use in children who are hard of
hearing (CHH), based on parent-report measures, and identify factors that influence longitudinal
trends in HA use.
2) Population 290 listeners with hearing impairment, average age of 2,5 (ranging from 0,5 to 7)
3) Performance These results indicated that the majority of CHH increased HA use over time. On average across
multiple visits, parents reported that their children wore their HAs for 10.63 hr per day. Maternal
education level predicted longitudinal trends in HA use for infants and school-age CHH.
in risk analysis)
The study shows, that audiologists and service providers might aid in improving HA use in children by
providing regular hands-on training with the HAs and individualized problem-based strategies to address
the challenges families experience with attaining a high level of use.
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Reference C2-110
McCreery RW, Brennan M, Walker EA, Spratford M. Perceptual Implications of Level- and Frequency-Specific
Deviations from Hearing Aid Prescription in Children. J Am Acad Audiol. 2017 Oct;28(9):861-875.
1) Objective The goals of this study were to determine how well HAs match prescriptive targets across ranges
of frequency and intensity of speech and to determine how level- and frequency-dependent
deviations from prescriptive target affect speech recognition in quiet and in background noise.
2) Population 166 listeners with hearing impairment, age between 6 and 8 y
3) Performance Children who had deviations larger than 5 dB from prescriptive target at all three input levels
had poorer LNT word recognition in quiet. Children with lower 4 kHz levels through their HAs
had both poorer recognition in quiet and in noise
in risk analysis)
The study shows the importance of providing audibility for speech across a range of inputs and frequencies.
Children had better speech recognition outcomes than peers with HAs that were not optimally fitted to
prescriptive targets.
Reference C2-112
Kirby BJ, Kopun JG, Spratford M, Mollak CM, Brennan MA, McCreery RW. Listener Performance with a Novel Hearing
Aid Frequency Lowering Technique. . J Am Acad Audiol. 2017 Oct;28(9):810-822
1) Objective This study examined speech perception performance, listening effort, and subjective sound
quality ratings with conventional hearing aid processing and a new frequency-lowering signal
processing strategy called frequency composition (FC) in adults and children.
2) Population 12 listeners with hearing impairment, average age of 12 (ranging from 0,5 to 7)
3) Performance Overall, there were few significant differences in speech perception, listening effort, or
subjective sound quality between FC and conventional processing, effects of listener age, or
longitudinal changes in performance.
in risk analysis)
is a moderate positive contribution for the indication
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The study indicate that when high-frequency speech sounds are made audible with conventional
processing, speech recognition ability and listening effort are similar between conventional processing and
FC. Despite the lack of benefit to speech perception, some listeners still preferred FC, suggesting that
qualitative measures should be considered when evaluating candidacy for this signal processing strategy.
Reference A1-4
Laperuta EB, Fiorini AC. Satisfaction of elderly individuals with hearing aids in the first six months of use.
J Soc Bras Fonoaudiol. 2012;24(4):316-21.
1) Objective The purpose of this study was to analyze the satisfaction of elderly individuals in the first six
months of use of hearing aids
2) Population 22 listeners with hearing impairment (ranging from 63 to 87)
3) Performance the results of SADL indicated that the overall score, the positive effects and the negative factors were
different when comparing one, three and six months of hearing aids use. In the overall score and the
category of positive effects, three months of use was enough to raise the scores that remained stable in the
range of six months. However, the category if negative factors only showed
in risk analysis)
The study shows, that the users will be most satisfied after three month of consistent use.
Reference A1-21
Kam AC. Hearing-aid outcomes in Chinese adults: clinical application and psychometric properties of the Chinese
version of the Satisfaction with Amplification in Daily Life questionnaire. Int J Audiol. 2012 Jun;51(6):450-5.
1) Objective The aims of this study were to investigate hearing-aid satisfaction in a Chinese population with
the Chinese version of the SADL (SADL-CH) questionnaire and to determine its reliability and
validity.
3) Performance The study reported in this paper shows the SADL-CH questionnaire is a reliable and valid instrument for
measuring hearing-aid satisfaction outcomes. However, the level of hearing-aid satisfaction in Chinese
adults was generally lower than that reported in studies conducted among Western populations. All the
monaurally fitted patients in the study explained this.
in risk analysis)
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The study shows, that the hearing aid user satisfaction can differ depending on the geographical
population.
Reference A1-39
Mondelli MF, Magalhães FF, Lauris JR. Cultural adaptation of the SADL (satisfaction with amplification in daily life)
questionaire for Brazilian Portuguese. Braz J Otorhinolaryngol. 2011 Sep-Oct;77(5):563-72.
1) Objective To make a cultural adaptation of the SADL (Satisfaction with Amplification in Daily Life)
questionnaire to use with the Brazilian population; to assess its reproducibility and to describe
its results in patients fit with a hearing aid.
2) Population 30 listeners with hearing impairment, average age of 66
3) Performance Reproducibility of the questionnaire was satisfactory. This study yielded a good performance to
identify the questionnaire efficacy, because the users were considerably satisfied with their
instrument
in risk analysis)
The study shows, that the users satisfaction stands out as a reliable measure because it
encompasses a number of factors, and it depends on the user’s perception and behavior, which
is not associated only with the hearing aid performance
Reference A1-46
Liu H, Zhang H, Liu S, Chen X, Han D, Zhang L. International outcome inventory for hearing aids (IOI-HA): results from
the Chinese version. Int J Audiol. 2011 Oct;50(10):673-8.
1) Objective The purpose of this paper is to present data of the Chinese version of the IOI-HA, and examine
the effectiveness of the hearing aid service.
3) Performance Our results showed that the participants reported relatively high-level outcomes, indicating
favorable attitudes towards the hearing aid. The outcome, especially for the mild-moderate
hearing loss, exceeded the normative data, which may be due to the improvement in signal
processing technologies since the IOI-HA norms were introduced in 2002,
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in risk analysis)
The study shows, that the hearing aid users tend to improve satisfaction as technology moves
forward.
Reference A1-47
Meister H, Grugel L, Meis M, Kiessling J. Use of self-assessment inventories in hearing-aid provision: German versions
of ECHO and SADL. Int J Audiol. 2012 Feb;51(2):135-42
1) Objective This study presents German versions of the ECHO (expected consequences of hearing aid
ownership) and SADL (satisfaction with amplification in daily life) self-assessment inventories
2) Population 583 listeners with hearing impairment, average age of 69 y
3) Performance The present study shows that the German versions of the ECHO and the SADL demonstrate psychometric
properties comparable to those of the original inventories. With regard to the SADL outcome, subscale
values of the present study are higher than in the original study. This could be due to relatively low
(realistic) expectations due to a subsidiary system in Germany, which could produce relatively higher
satisfaction.
in risk analysis)
The study shows, that the hearing aid users satisfaction could be affected by the expectation to
the device.
Reference A1-118
Hickson L, Clutterbuck S, Khan A. Factors associated with hearing aid fitting outcomes on the IOI-HA. Int J Audiol. 2010
Aug;49(8):586-95
1) Objective The aims of this research were to describe the outcomes of hearing aid fitting for a large sample
of clients fitted in private practice settings in Australia, and to investigate factors that
significantly influence IOI-HA outcomes.
2) Population 1653 listeners with hearing impairment, (ranging from 20 to 90)
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3) Performance Factors that were most strongly associated with positive changes in IOI-HA scores were greater satisfaction
with the hearing aid attributes of aid fit/comfort, clarity of tone, and sound and comfort with loud sounds,
and greater satisfaction in the listening situations of conversation with one person, in small groups, in large
groups, and outdoors.
in risk analysis)
5) Conclusion As seen in Table 76 above, compounded weight W for the study was 0,25. In other words, there is a fair
positive contribution for the indication
The study shows, that the hearing aid users satisfaction in a larger scale, depends on a wide range of
audiological factors associated with the client.
Reference A1-148
Williams VA, Johnson CE, Danhauer JL. Hearing aid outcomes: effects of gender and experience on patients' use and
satisfaction. J Am Acad Audiol. 2009 Jul-Aug;20(7):422-32
1) Objective The purposes of this study were to assess patients’ satisfaction and benefit with their hearing
aids focusing on gender and experience effects using the IOI-HA with patients having advanced
hearing aid technology
3) Performance The results of this investigation support earlier contention that the IOI-HA can be used along with practice-
specific questionnaires as research tools to study users’ satisfaction with their hearing aids and as clinical
outcome measures to monitor quality assessment for individual practices. The present study showed that
these patients were generally happy with their hearing aid outcomes, yet there was still room for
improvement (e.g., overall satisfaction scores with IOI-HA means ranged from 3.75 to 4.38 out of a possible
5.0).
in risk analysis)
The study shows, that the users, even though well fitted, still have perceptual issues.
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Reference A1-183
Bertoli S, Staehelin K, Zemp E, Schindler C, Bodmer D, Probst R. Survey on hearing aid use and satisfaction in
Switzerland and their determinants. Int J Audiol. 2009 Apr;48(4):183-95
1) Objective The study aims to determine in a large cross-sectional sample factors that may have affected the
outcome of hearing aid provision.
3) Performance The survey provides evidence that satisfaction were high compared to the data from other countries,
supporting the efficiency and appropriateness of the Swiss model. There is also evidence that binaural
amplification and devices with advanced signal processing features contribute to successful hearing aid
fitting, resulting in longer duration of use.
in risk analysis)
The study shows, that hearing aid satisfaction is high using modern technology.
Reference A1-188
Roup CM, Noe CM. Hearing aid outcomes for listeners with high-frequency hearing loss. Am J Audiol. 2009
Jun;18(1):45-52.
1) Objective The primary purpose of the present study was to determine unaided hearing handicap,
perceived hearing aid benefit, and perceived hearing aid satisfaction for two groups of listeners
with high frequency hearing loss using CIC hearing instruments
2) Population 53 listeners with hearing impairment (ranging from 38 to 79)
3) Performance Results of the present study indicate that patients with high frequency hearing loss perceive satisfaction
from amplification using CIC hearing aids. The results also shows large variability associated with both
groups, which emphasizes the importance of appropriate counseling and follow-up when fitting these types
of listeners.
in risk analysis)
The study shows, that even small size hearing aids like modern CIC provide high satisfaction.
However, it also emphasizes the importance of appropriate counseling and follow-up,
particularly regarding realistic hearing aid expectations for this group.
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Reference # A2-461
Convery E, Keidser G, Hickson L, Meyer C. The Relationship Between Hearing Loss Self-Management and
Hearing Aid Benefit and Satisfaction. Am J Audiol. 2019 Jun 10;28(2):274-284
1) Objective The purpose of this study was to investigate the relationship between self-reported
hearing loss self-management and hearing aid benefit and satisfaction.
2) Population 37 adults with hearing impairment average age of 67 y (ranging from 62 to 90 y)
3) Performance Participants who reported better self-management of the effects of their hearing loss on
their emotional well-being and social participation were more likely to report less aided
listening difficulty in noisy and reverberant environments and greater satisfaction with
the effect of their hearing aids on their self-image.

The highlight the potential for using information about a patient's hearing loss self-
management in different domains as part of clinical decision making and
management planning.
Reference # A2-467
Bertozzo MC, Blasca WQ. Comparative analysis of the NAL-NL2 and DSL v5.0a prescription procedures in the
adaptation of hearing aids in the elderly. Codas. 2019 Aug 15;31(4).
1) Objective To comparatively analyze the NAL-NL2 and DSL v5.0a prescriptive methods
according to the hearing aids individualized programming for the elderly with
hearing loss.
3) Performance The two prescriptions was analyzed acoustically and perceptually through speech
intelligibility in noise.

The findings of this study point to an equivalent performance between DSL v5.0a and
NAL-NL2 prescription procedures in HA adaptation in the elderly with hearing loss. The
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amplification calculated by DSL v5.0a provided better speech perception in silence.

Reference # A2-476,
Wu X, Ren Y, Wang Q, Li B, Wu H, Huang Z, Wang X. Factors associated with the efficiency of hearing aids for
patients with age-related hearing loss. Clin Interv Aging. 2019 Feb 26;14:485-492.
1) Objective The aim of this study was to investigate the satisfaction of
age-related hearing loss (ARHL) or presbycusis patients with individual,
accurate, and precise fitting progress, and to explore the related influencing factors and
their role in predicting the efficiency of hearing aids.
3) Performance Audiometric measures had a statistically significant effect on the total IOI-HA scores after
hearing aid intervention.
5) Conclusion As seen in Table 76 above, compounded weight W for the study was 0,25. In other
words, there is a fair positive contribution for the indication

Hearing threshold is partly associated with the efficiency of hearing aid fitting. Those
who hear well possibly benefit more from the hearing aids. But it is not an important
factor, as the efficiency mainly relies on the cognitive function.
Reference # A2-484,
Wu YH, Stangl E, Chipara O, Hasan SS, DeVries S, Oleson J. Efficacy and Effectiveness of Advanced Hearing Aid
Directional and Noise Reduction Technologies for Older Adults With Mild to Moderate Hearing Loss. Ear Hear.
2019 Jul/Aug;40(4):805-822
1) Objective The purpose of the present study was to investigate the laboratory
efficacy and real-world effectiveness of advanced directional microphones
and digital noise reduction algorithms relative to basic-level features of contemporary

hearing aids.
3) Performance Linear mixed models first revealed that none of the interactions between HA model and
feature status was significant nor was the difference between the premium-on and basic-
on conditions regarding satisfaction (SADL)
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Results of laboratory tests supported the effect of premium features, premium HAs, on
improving speech understanding and localization accuracy. It also suggests older adults
with mild-to-moderate hearing loss are unlikely to perceive the additional benefits
provided by the premium features in their daily lives.
Reference # A2-505,
Valente M, Oeding K, Brockmeyer A, Smith S, Kallogjeri D. Differences in Word and Phoneme Recognition in
Quiet, Sentence Recognition in Noise, and Subjective Outcomes between Manufacturer First-Fit and Hearing
Aids Programmed to NAL-NL2 Using Real-Ear Measures. J Am Acad Audiol. 2018 Sep;29(8):706-721.
1) Objective To examine if significant differences were present in monosyllabic word and phoneme
recognition (consonant-nucleus-consonant; CNC) in quiet, sentence recognition in noise
(Hearing in Noise Test; HINT), and subjective outcomes between hearing aids fit using
one manufacturer's first-fit and the same hearing aids with a programmed-fit using REM
to NAL-NL2 prescriptive target.
2) Population 24 adults with hearing impairment average age of 72,1 y (SD 10,4 y)
3) Performance An average high frequency boost for the programmed-fit of up to 14 dB was seen. A
significant median advantage of 15% for words and 7.7% for phonemes for the
programmed-fit compared with first-fit at 50 dB sound pressure level (SPL) and 4% for
words at 65 dB SPL. No significant differences for the HINT reception threshold for
sentences

Improved word and phoneme recognition for soft and words for average speech in quiet
were reported for the programmed-fit. Seventy-nine percent of the participants
preferred the programmed-fitting versus first-fit which acknowledge the use of hearing
verification.
Reference # A2-506
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Akeroyd MA, Guy FH, Harrison DL & Suller SL (2014). A factor analysis of the SSQ (Speech, Spatial, and Qualities
of Hearing Scale), International Journal of Audiology, 53:2, 101-114, DOI: 10.3109/14992027.2013.824115
1) Objective To gather SSQ data on a large, diverse group in order to obtain norm data, analyze basic
statistic properties and perform a factor analysis in order to find the underlying principal
components.
2) Population 1220 persons who have attended the clinic over 10 years. App. 30% unaided, 50%
unilaterally aided and 20% bilaterally aided.
3) Performance Not compared within listeners.
4) Risk (safety) NA
5) Conclusion Found three clear factors, essentially corresponding to the three main sections of the
SSQ, and termed “speech understanding”, “spatial perception” and “clarity, separation,
and identification”. The analyses across the three groups were broadly similar.
Reference # A2-513
Ng, E. H. N., Rudner, M., Lunner, T., & Rönnberg, J. (2013). Relationships between self-report and cognitive
measures of hearing aid outcome. Speech, Language and Hearing, 16(4), 197-207.
1) Objective To examine the relationship between cognitive measures and self-report hearing aid
outcome. A sentence-final word identification and recall (SWIR) test was used to
investigate how hearing aid use may relate to experienced explicit cognitive processing.
A visually based cognitive test battery was also administered. To measure self-report
hearing aid outcome, the International Outcome Inventory – Hearing Aids (IOI-HA) and
the Speech, Spatial and Qualities of Hearing Scale (SSQ) were employed
2) Population 26 experienced hearing aid users (mean age of 59 years, SD = 7, range: 32 to 65 years)
with symmetrical moderate-to moderately severe sensorineural hearing loss. The mean
puretone average at 0.125, 0.25, 0.5, 1, 2, 3, 4, 6 and 8 kHz was 49.8 dB HL, SD = 6.4.
3) Performance The results of the IOI-HA (n = 25) and SSQ (n= 26) are generally comparable (within 1 SD)
to published studies on hearing aid users with more than 6 months of experience. The
mean SNR yielding 84% intelligibility was 2.69 dB SNR (SD = 2.11). There was no
comparison unaided – aided nor different hearing aid settings.
4) Risk (safety) No risk identified in the use of this device
5) Conclusion This study demonstrated a relationship between cognitive measures and residual
difficulty reported by hearing aid users. The results showed that reported residual
difficulty with hearing aids may relate to experienced explicit processing in difficult
listening conditions, such that individuals with better cognitive capacity tended to report
more remaining difficulty in challenging listening situations
Reference # A2-514 / A2-525
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Anderson, M., Rallapalli, V., Schoof, T., Souza, P., & Arehart, K. (2018). The use of self-report measures to
examine changes in perception in response to fittings using different signal processing parameters.
1) Objective This study examined how self-perceived performance varied as a function of
modifications in signal processing using two self-report measures – SSQ and
EAR(Effectiveness of Auditory Rehabilitation).
2) Population 40 were included in final data analyses, aged 54 – 90 years (mean age 72 years, 19
women). Participants all had sensorineural hearing loss, with air-bone gaps < 15 dB at
octave frequencies from 0.5 to 4 kHz and normal tympanograms. Inclusion criteria were
a high-frequency pure-tone average (HFPTA; 0.5, 1, 2, 4 kHz) of at least 30 dB HL, with
audiometric thresholds up to 3 kHz ≤ 70 dB HL.
3) Performance Each participant was fit with the same commercial hearing aids twice, once with a mild
signal processing (MildSP) fitting and once with a strong signal processing (StrongSP)
fitting. Both SSQ49 and EAR revealed statistically significant differences between ‘mild’
and ‘strong’ (Speech and Quality subscales).
4) Risk (safety) Unknown device, no risk reported
5) Conclusion Both the SSQ49 and the EAR revealed difference between signal processing conditions.
Reference # A2-517
Matsumoto N, Suzuki N, Iwasaki S, Ishikawa K, Tsukiji H, Higashino Y, Tabuki T, Nakagawa T. Language-specific
strategy for programming hearing aids – A double-blind randomized controlled crossover study. Auris Nasus
Larynx. 2018 Aug;45(4):686-692. doi: 10.1016/j.anl.2017.11.007. Epub 2017 Nov 20. PMID: 29157624.
1) Objective A double-blind randomized controlled crossover study was performed to determine
whether or not Oticon’s modified amplification strategy (VAC-J) provides subjectively
preferable hearing aids for Japanese-speaking hearing aid users compared to the same
company’s original amplification strategy (VAC).
2) Population Twenty-two participants completed the study. Median age 78 yrs, 12 females, 10 males,
9 inexperienced users, 13 experienced users. PA better ear 54,1 dB HL, PA worse ear 61.7
dB HL.
3) Performance Comparing Oticon VAC to Oticon VAC-J dedicated to Japanese language. Device: Oticon
Alta2, BTE or RITE style assed via SSQ49.
5) Conclusion No statistically significant SSQ effect between the two compression strategies (but
significant preference for VAC-J).
Reference # A2-523
Humes LE, Kidd GR, Lentz JJ. Auditory and cognitive factors underlying individual differences in aided speech-
understanding among older adults. Front Syst Neurosci. 2013 Oct 1;7:55. doi: 10.3389/fnsys.2013.00055.
Erratum in: Front Syst Neurosci. 2016 Nov 11;10 :91. PMID: 24098273; PMCID: PMC3787592.
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1) Objective This study was designed to address individual differences in aided speech understanding
among a relatively large group of older adults.
2) Population The group of older adults consisted of 98 adults (50 female and 48 male) ranging in age
from 60 to 86 (mean = 69.2). Hearing loss was typical for this age group and about 90%
had not worn hearing aids.
3) Performance A large test battery + SSQ49 was administered. The measures used were demonstrated
to be reliable in older adults and, when compared to a reference group of 28 young
normal-hearing adults, age-group differences were observed on many of the measures.
The older adults scored lower than young normal hearing on SSQ speech (p < 0.021).
4) Risk (safety) NA
5) Conclusion Test-retest on a subgroup (N = 31), with no significant test-retest effect. SSQ data for
three sections + overall. The results for the SSQ are generally consistent with the effects
of age and hearing loss observed for this self-report measure previously (Gatehouse and
Noble,2004;Singh and Pichora-Fuller, 2010; Banh et al.,2012).
Reference # A2-526
Clinicaltrials.gov NCT00371449:: Predicting Success With Hearing Aids (2015)
1) Objective The results of this study may demonstrate that speech-in-noise test results can be a
predictor of hearing aid success. The results of this study also may lead to further studies
that can evaluate interventions to improve hearing aid success for individuals who are
identified as unsuccessful hearing aid users.
2) Population 120
3) Performance Assessed via WIN (words in noise) as predictor and SSQ, IOI-HA, SADL, MARS-HA,
Acceptable Noise Level (ANL), as outcome measures. No data have been reported in
clinicaltrials.gov or found in publications.
4) Risk (safety) NA
5) Conclusion The results could not be located – the study may never have been completed.
Reference # C2-143,
Walker EA, Sapp C, Dallapiazza M, Spratford M, McCreery RW, Oleson JJ. Language and Reading Outcomes in
Fourth-Grade Children With Mild Hearing Loss Compared to Age-Matched Hearing Peers. Lang Speech Hear
Serv Sch. 2020 Jan 8;51(1):17-28
1) Objective The goal of the current article is to expand the evidence base surrounding
outcomes for the current generation of children with mild bilateral hearing loss at risk for
language and reading delays.
2) Population 60 listeners with hearing impairment, average age of 10,4 (ranging from 9,8 to 11,5 y)
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3) Performance Group comparisons indicated that children with NH significantly outperformed children
with MBHL on tests of morphological awareness and listening comprehension.

The current results provide evidence that children with
MBHL are at risk for persistent language deficits by 4th grade, particularly in aspects of
language that involve form.
Reference # C3-19,
Bagatto M, Moodie S, Brown C, Malandrino A, Richert F, Clench D, Scollie S, Convery E, Keidser G. Prescribing and
Verifying Hearing Aids Applying the American Academy of Audiology Pediatric Amplification Guideline: Protocols and
Outcomes from the Ontario Infant Hearing Program. J Am Acad Audiol. 2016 Mar;27(3):188-203
1) Objective The purpose is to illustrate hearing-related outcomes of a infant hearing Program as well as to
present an update of the protocol.
2) Population 115 children with hearing impairment average age of 29 month (ranging from 1,3 to 115
months)
3) Performance The results of the study showed that outcomes from the infant hearing program reveal protocol
elements that can be executed clinically and when they are, typically developing children who
wear hearing aids are meeting auditory development and performance milestones.
4) Risk (safety) E.g., no risk identified in the use of this device (or state risk and the mitigation to resolve the risk
in risk analysis)

The application of state-of-the-art hearing aid fitting practices within the program supports good
outcomes for infants and children with hearing loss.
Reference # C3-31,
Walker EA, Holte L, McCreery RW, Spratford M, Page T, Moeller MP. The Influence of Hearing Aid Use on Outcomes of
Children With Mild Hearing Loss. J Speech Lang Hear Res. 2015 Oct;58(5):1611-25
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1) Objective The purpose is to examine the effects of consistent hearing aid use on outcomes in children with
mild hearing loss (HL).
2) Population 38 children with hearing impairment average age of 6,2 y (ranging from 70 to 86 months)
3) Performance The results of the study showed that full-time HA users demonstrated significantly higher scores
on vocabulary and grammar measures compared with nonusers. There were no significant
differences between the 3 age groups on articulation or speech perception measures.
in risk analysis)

The current results provide evidence that children’s language development benefits from
consistent HA use.
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Reference # C3-43,
Bentler R, Walker E, McCreery R, Arenas RM, Roush P. Nonlinear frequency compression in hearing aids: impact on
speech and language development. Ear Hear. 2014 Jul-Aug;35(4):e143-52
1) Objective The research questions of this study were: Are children using nonlinear frequency compression
(NLFC) in their hearing aids getting better access to the speech signal or showing different
speech and language skills than children using conventional processing schemes?
2) Population 66 children with hearing impairment average age of 4,2 y (ranging from 3 to 5 y)
3) Performance The results indicate that the audibility provided did not differ between the technology options.
in risk analysis)

Children fit with NLFC had similar audibility, as measured by a modified Speech Intelligibility
Index, compared with a matched group of children using conventional technology. In turn, there
were no differences in their speech and language abilities.

Reference # C3-47,
Tomblin JB, Oleson JJ, Ambrose SE, Walker E, Moeller MP. The influence of hearing aids on the speech and language
development of children with hearing loss. JAMA Otolaryngol Head Neck Surg. 2014 May;140(5):403-9
1) Objective The purpose is to investigate the contributions of aided hearing and duration of HA use to
speech and language outcomes in children with mild-to-severe HL
2) Population 180 children with hearing impairment average age of 4,2 y (ranging from 3 to 5 y)
3) Performance The results of the study showed that measures of the gain in hearing ability for speech provided
by the HA were significantly correlated with levels of speech and language ability.
in risk analysis)

The degree of improved hearing provided by HAs was associated with better speech and
language development in children. In addition, the duration of HA experience interacted with the
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aided hearing to influence outcomes. These results provide support for early HA fitting and HA
provision to children with mild HL.

Reference # C3-53,
Ching TY, Day J, Zhang V, Dillon H, Van Buynder P, Seeto M, Hou S, Marnane V, Thomson J, Street L, Wong A, Burns L,
Flynn C. A randomized controlled trial of nonlinear frequency compression versus conventional processing in hearing
aids: speech and language of children at three years of age. Int J Audiol. 2013 Dec;52 Suppl 2:S46-54.
1) Objective To determine the effect of nonlinear frequency compression (NLFC) on children's
development of speech and language at three years of age.
2) Population 44 children with hearing impairment with age ranging from 3 to 3,6 y
3) Performance Compared to children using conventional processing, receptive and expressive language was
higher but receptive vocabulary and consonant articulation scores were lower for children who
use NLFC. After allowing for the effect of multiple demographic variables, the difference in global
language scores between groups was not significant.
in risk analysis)
5) Conclusion As seen in Table 76 above, compounded weight W for the study was 1. In other words, there is
a compelling positive contribution for the indication

There is insufficient evidence to indicate a difference in language ability between children using
NLFC and those using conventional amplification.

Reference # C3-80,
Ching TY, Dillon H, Hou S, Zhang V, Day J, Crowe K, Marnane V, Street L, Burns L, Van Buynder P, Flynn C,
Thomson J. A randomized controlled comparison of NAL and DSL prescriptions for young children: hearing-aid
characteristics and performance outcomes at three years of age. Int J Audiol. 2013 Dec;52 Suppl 2:S17-28
1) Objective To determine the influence of choice of prescription and other child-, family- and
intervention-related factors on speech, language, and functional performance of hearing-
impaired children by three years of age.
2) Population 218 children with hearing impairment average age of 3 y (all were 3 y of age)
3) Performance Prescriptive targets were closely matched in children’s hearing aids. There were no
significant differences in children’s language, speech production, or functional
performance between prescriptions.
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There was no significant association between choice of hearing-aid prescription and
variance in children’s outcomes at three years of age.

Reference # C3-95,
Bagatto MP, Moodie ST, Malandrino AC, Richert FM, Clench DA, Scollie SD. The University of Western Ontario
Pediatric Audiological Monitoring Protocol (UWO PedAMP). Trends Amplif. 2011 Mar-Jun;15(1):57-76
1) Objective This study proposed and evaluated a guideline for outcome evaluation for infants and
children with hearing loss who wear hearing aids.
2) Population 129 children with hearing impairment average age of 21,7 months (ranging from 1,3 to
107 months)
3) Performance Results for the LittlEARS® questionnaire revealed that typically developing children with
hearing loss who wear hearing aids are meeting auditory development milestones

Overall, the work presented here will contribute to a better understanding of existing
norms for caregivers evaluation and assessment tools as well as provide a guideline for
outcome evaluation for infants and children who wear hearing aids.

Reference # C3-154,
Kiese-Himmel C. Receptive (aural) vocabulary development in children with permanent bilateral sensorineural
hearing impairment. J Laryngol Otol. 2008 May;122(5):458-65.
1) Objective The aural vocabulary development of children with binaural-aided residual hearing was
investigated in a prospective longitudinal analysis.
2) Population 33 children with hearing impairment average age of 53 months (ranging from 22 to 82
months)
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3) Performance On average, the study group scored below the normal range initially and made a
significant improvement over time. Significant predictive variables for successful
receptive vocabulary outcome were found to be degree of hearing loss, age at diagnosis
and nonverbal intelligence.

Study findings concur with international research results demonstrating the relationship
between hearing-impaired children’s receptive vocabulary and their severity of hearing
impairment, and also their age of hearing impairment diagnosis.

Reference # C3-215,
Tomblin JB, Oleson J, Ambrose SE, Walker EA, McCreery RW, Moeller MP. Aided Hearing Moderates the
Academic Outcomes of Children With Mild to Severe Hearing Loss. Ear Hear. 2020 Feb 5.
1) Objective This study used a large cohort of children to examine spoken language and academic
outcomes to examine whether aided hearing moderates the effect of HL
with regard to these outcomes.
2) Population 183 listeners with hearing impairment, recruited between 6 mo and 7 y (longitudinal)
3) Performance Oral language abilities of the children with mild and moderate HL were
similar to the normal hearing peers at each grade. Children with moderately-severe HL
had significantly poorer oral language and reading skills than their NH peers.

Children with moderately-severe losses were less skilled in language and reading than
the CNH and CHH children with mild and moderate losses. Audibility provided by hearing
aids was found to moderate the effects of HL with respect to these outcomes.
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Reference C4-44
McCreery RW, Bentler RA, Roush PA. Characteristics of hearing aid fittings in infants and young children. Ear
Hear. 2013 Nov-Dec;34(6):701-10.
1) Objective The present study sought to evaluate the proximity of the fitting to prescriptive targets
and aided calculated audibility of speech.
2) Population 195 listeners with hearing impairment, average age of 41 mos (ranging from 5 to 85 mos)
3) Performance Aided audibility was significantly predicted by the proximity to prescriptive targets and
pure-tone average, but not age in months. More than half (55%) of the children in the
study had at least one ear that deviated from prescriptive targets by more than 5 dB RMS
on average. Fittings based on average real-ear to coupler differences resulted in larger
deviations from prescriptive targets than fittings based on individually measured real-ear
to coupler differences.
4) Risk (safety) E.g. no risk identified in the use of this device (or state risk and the mitigation to resolve
The study emphasize the importance of training on expected audibility outcomes for
children who wear Has to help clinicians identify the impact of deviations from
prescriptive target on speech audibility.
Reference # U1-35,
José MR, Campos PD, Mondelli MF. Unilateral hearing loss: benefits and satisfaction from the use of hearing
aids. Braz J Otorhinolaryngol. 2011 Mar-Apr;77(2):221-8.
1) Objective To analyze the correlation between the prescribed grain and the insertion gain difference
and with the results obtained regarding the benefit and satisfaction with the use of
hearing aids in unilateral hearing impaired patients.
3) Performance The mean values in the analyses of the IOI-HA per item were positive and higher than
four points.

The satisfaction of individuals using hearing aid unilaterally is not completely correlated
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to the prescribed gain, because even if the target is not being reached in some
frequencies, the individuals were pleased as to the use of their hearing aids.

Reference # U1-38,
Brännström KJ, Wennerström I. Hearing aid fitting outcome: clinical application and psychometric properties of
a Swedish translation of the international outcome inventory for hearing aids (IOI-HA). J Am Acad Audiol. 2010
Sep;21(8):512-21
1) Objective To evaluate the hearing aid fitting outcome measured in a clinical setting using a Swedish
translation of the International Outcome Inventory for Hearing Aids (IOI-HA), to
determine the psychometric properties of the translation, and to examine how a number
of demographic variables such as type of hearing loss affect the outcome.
3) Performance Monaurally fitted subjects tend to report lower scores on average, but monaural or
binaural hearing aid fitting do not significantly affect the subjective outcome.
words, there is a strong positive contribution for the indication

Monaurally fitted subjects tend to report poorer scores on average, but monaural or
binaural hearing aid fitting does not significantly affect the subjective outcome.
Render evidence for hsafety:

Reference # U1-40,
Cox RM, Schwartz KS, Noe CM, Alexander GC Preference for one or two hearing AIDS among adult patients. Ear
Hear. 2011 Mar-Apr;32(2):181-97.
1) Objective Previous research has consistently shown that a substantial proportion of bilaterally
fitted patients actually prefer to use only one hearing aid. This study explored whether
this pattern of preferences is seen with technologically advanced hearing aids.
3) Performance Previous research was confirmed with modern technology hearing aids: after the field
trial, 46% of the subjects preferred to use one hearing aid rather than two. Subjects who
preferred two hearing aids tended to report better real-world outcomes than those who
preferred one. However, the best predictive approach from these data yielded accurate
predictions for only two-thirds of the subjects.
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The results of this research challenge practitioners to recognize that many patients who
seem to be ideal candidates for bilateral aiding will actually prefer to wear only one
hearing aid. Furthermore, at this time, there is no accurate method that will predict
which patients will prefer one hearing aid rather than two.

Reference # U1-43,
Bertoli S, Bodmer D, Probst R. Survey on hearing aid outcome in Switzerland: associations with type of fitting
(bilateral/unilateral), level of hearing aid signal processing, and hearing loss. Int J Audiol. 2010 May;49(5):333-
46
1) Objective To determine the individual and technological factors related to hearing aid outcome. In
particular the associations of hearing loss, level of signal processing, and fitting type
(bilateral versus unilateral fitting) with hearing aid use, satisfaction with and
management of the aid were evaluated.
3) Performance In our study, bilateral amplification was significantly associated with a higher rate of
regular use of hearing aids. Although respondents wearing two aids reported more
frequently to be very satisfied with their aids and able to handle them very well, these
results were not confirmed in logistic regression analyses, where other potentially
contributing factors were taken into account.

It was concluded that bilateral amplification and advanced signal processing features
may contribute to successful hearing aid fitting, but the resulting differences must be
considered to be relatively small.

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Reference # U1-50,
Boymans M, Goverts ST, Kramer SE, Festen JM, Dreschler WA. A prospective multi-centre study of the benefits
of bilateral hearing aids. Ear Hear. 2008 Dec;29(6):930-41.
1) Objective In this prospective study the benefits of a second hearing aid were evaluated objectively
(functional tests) and subjectively (questionnaires).
3) Performance In a number of respects bilaterally fitted hearing aids offered a benefit relative to
unilaterally fitted hearing aids (the so-called bilateral benefit), both subjectively
(questionnaire) and objectively (speech perception in noise and localization). However,
we found large interindividual differences and not all differences were clinically relevant.
The results of the diagnostic tests showed that it was not possible to predict the bilateral
benefit from a priori information based on headphone tests. At the end of the trial
period 93% of the participants preferred a bilateral fitting.

In this study, 93% of the participants preferred two hearing aids after the trial period.
They showed a higher incidence of hearing aid use and a higher hearing aid satisfaction
than the group who preferred one hearing aid (7%).

Reference # U1-51,
Boymans M, Goverts ST, Kramer SE, Festen JM, Dreschler WA. Candidacy for bilateral hearing aids: a
retrospective multicenter study. J Speech Lang Hear Res. 2009 Feb;52(1):130-40.
1) Objective The goal of this study was to find factors for refining candidacy criteria for bilateral
hearing aid fittings. Clinical files of 1,000 consecutive hearing aid fittings were analyzed.
3) Performance No significant differences were found between the unilateral and bilateral groups for
hearing aid use. The matched bilaterally fitted group showed higher benefit from
amplification for detection, reverberation, and localization (this last aspect is in
agreement with previous research) than the unilaterally fitted group. However, the
comfort of loud sounds was significantly worse for the bilateral group than for the
unilateral group.
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In a multicenter population, 59% of the fittings were bilateral, mostly in individuals with
relatively symmetric hearing losses

Reference # U1-77
Kwak MY, Kang YK, Kim DH, An YH, Shim HJ. Further Beneficial Effect of Hearing Aids on Speech Recognition
Performance Besides Amplification: Importance of the Restoration of Symmetric Hearing. Otol Neurotol. 2018
Sep;39(8):e618-e626.
1) Objective The purpose to compare
the beneficial effects depending on the restoration of symmetric hearing with
different amplification settings in various hearing impairment conditions
2) Population 62 adults with hearing impairment average age of 60,4 y
3) Performance speech perception in noise was significantly improved in bilateral HA users and unilateral
HA users in the worse ear, whereas it was not improved in unilateral HA users in the
better ear or in unilateral HA users with symmetric hearing thresholds. No effect on
satisfaction (IOI-HA) was seen.

These results demonstrate the benefits of HAs on speech perception in noise, in addition
to their amplification effect, but only when HA restores symmetric hearing.
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Reference A1-154
Rocha AV, Mondelli MFCG. Applicability of the real ear measurement for audiological intervention of
tinnitus. Braz J Otorhinolaryngol. 2020 Jan-Feb;86(1):14-22.
1) Objective Analysis of the applicability of real ear measurements for audiological intervention of tinnitus
through specific evaluation, selection, verification and validation of the hearing aids
combined with the sound generator.
2) Population 40 listeners with hearing impairment and tinnitus, mean age was 67 y, (standard deviatrion
of 8,4y)
3) Performance The study demonstrated the effectiveness of sound generators in the treatment of tinnitus.
Its effective use combined with HA and associated with counseling, resulted in improve-
ments in the annoyance of tinnitus and consequently, in the quality of life index of
individuals.
there is a weak contribution for the indication

The present study concluded that the audiological intervention with an individualized sound
stimulus can be effective at least in the medium term. Data that specifies that the
verification of sound generator was effective at the real ear measurements are important in
the evaluation and intervention of the complaint.
11.11.2 Tinnitus
Reference # A1-13,
Sereda M, Davies J(1)(2), Hall DA(1)(2). Pre-market version of a commercially available hearing instrument with
a tinnitus sound generator: feasibility of evaluation in a clinical trial. Int J Audiol. 2017 Apr;56(4):286-294
1) Objective The objective is to evaluate different listener programs available within the pre-market
version of Oticon Alta with Tinnitus Sound Generator.
2) Population 8 listeners with hearing impairment and tinnitus average age of 67,3 (ranging from 62 to
72 yrs)
3) Performance All eight participants reported the physical aspects and noise options on the
experimental device to be acceptable. Programs with amplification and masking features
were equally preferred over the basic amplification-only program. Individual preferences
for the different program options varied widely, both across participants and across
listening situations.
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words, there is a weak contribution for the indication

Overall, all participants found the intervention device to be acceptable in terms of its
physical aspects, choice of program options (in particular the ocean sound) and the
listening experience provided by the amplification.
Reference A1-16,
Henry JA, Stewart BJ, Griest S, Kaelin C, Zaugg TL, Carlson K. Multisite Randomized Controlled Trial to Compare
Two Methods of Tinnitus Intervention to Two Control Conditions. Ear Hear. 2016 Nov/Dec;37(6):e346-e359
1) Objective To evaluated whether tinnitus masking (TM) and tinnitus retraining therapy (TRT)
decreased tinnitus severity more than the two control groups: an attention-control
group that received tinnitus educational counseling (and hearing aids if needed; TED),
and a 6-month-wait-list control (WLC) group.
2) Population 34 listeners with hearing impairment (TRT group), average age of 60,1 (ranging from 30
to 86 yrs)
3) Performance Results from this multisite RCT evaluating TRT (and TM) supported some but not all of
the findings from the previous trial, in that TRT (and TM) reduced tinnitus severity over
18 months.
4) Risk (safety) E.g. no risk identified in the use of this device (or state risk and the mitigation to resolve
words, there is a fair contribution for the indication

TRT resulted in positive outcomes relative to the waiting list control group. Effect sizes
would be considered moderate, in comparison to the large effect sizes seen for the TRT
group in the previous study.
Reference A1-95
Sweetow RW, Sabes JH. Effects of acoustical stimuli delivered through hearing aids on tinnitus. J Am Acad Audiol.
2010 Jul-Aug;21(7):461-73.
1) Objective To assess the effects on relaxation, tinnitus annoyance, tinnitus handicap, and tinnitus
reaction from the use of a hearing aid that incorporates combinations of amplification, fractal
tones, and white noise.
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2) Population 14 listeners with hearing impairment, age ranging from 34 to 72 yrs
3) Performance Thirteen of 14 participants reported that their tinnitus annoyance, as measured by the Tinnitus
Annoyance Scale, was reduced for at least one of the amplified conditions (with or without
fractal tones or noise), relative to the unaided condition. The majority (86%) indicated that it
was easier to relax while listening to fractal signals. Participants had preferences for certain
programs and fractal characteristics.
there is a weak contribution for the indication

The results suggest that use of acoustic stimuli, particularly fractal tones, delivered though
hearing aids can provide amplification while allowing for relief for some tinnitus sufferers.
Reference A1-100
Korres S, Mountricha A, Balatsouras D, Maroudias N, Riga M, Xenelis I. Tinnitus Retraining Therapy (TRT): outcomes
after one-year treatment. Int Tinnitus J. 2010;16(1):55-9.
1) Objective To present results regarding the efficacy of TRT for tinnitus relief in patients with clinically
significant tinnitus compared to a group treated with vasoactive agents.
2) Population 33 listeners of which 88% had hearing impairment, average age of 63,9 (ranging from 29 to
88)
3) Performance The THI score was significantly improved in the TRT group, as well as mean VAS scores, in all
measures. Comparison of the mean improvement of THI and VAS scores after treatment
showed significant differences between the two groups, favoring TRT treatment.
there is a weak positive contribution for the indication
The data suggest that TRT is an effective treatment. It reduces the level of annoyance
induced by tinnitus and improves the ability of patients to work, sleep, relax or be
concentrated.
Reference A2-3
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Barozzi S, Ambrosetti U, Callaway SL, Behrens T, Passoni S, Bo LD. Effects of Tinnitus Retraining Therapy with
Different Colours of Sound. Int Tinnitus J. 2017 Dec 1;21(2):139-143.
1) Objective To evaluate the effect of sound generators of different colors on the treatment outcome of
TRT in subjects affected by subjective chronic debilitating tinnitus.
2) Population 56 listeners with hearing impairment, average age of 56 (ranging from 21 to 73 yrs)
3) Performance Significant improvements were obtained in both groups following 3 and 6 months after
fitting. No significant difference was found between the two groups using one or the other
type of sound. Two thirds of the patient preferred white noise, making it the most appealing
amongst the options.
there is a fair contribution for the indication

TRT with different colour sound generators is effective in reducing the discomfort caused by
tinnitus in normal hearing patients. Enabling the patients to choose their preferred sound
after short trial periods achieved higher patient satisfaction. This practice could help tailor
individualized treatment for each patient compared to a standard tinnitus masker.
Reference A2-8
Bauer CA, Berry JL, Brozoski TJ. The effect of tinnitus retraining therapy on chronic tinnitus: A controlled trial.
Laryngoscope Investig Otolaryngol. 2017 May 28;2(4):166-177.
1) Objective The goal of this study was to compare treatment outcomes for chronic bothersome tinnitus
after Tinnitus Retraining Therapy (TRT) versus standard of care treatment (SC) and to
determine the longevity of the effect over an 18-month period.
2) Population 19 listeners with hearing impairment, age ranging from 18 to 75 yrs
3) Performance Significant improvement in tinnitus impact occurred after both TRT and SC therapy, with a
larger treatment effect obtained in the TRT group. Lasting therapeutic benefit was evident at
18 months in both groups.
there is a compelling positive contribution for the indication.
Both TRT and SC, as defined in the present study, provided lasting therapeutic benefit to
individuals with chronic bothersome tinnitus. TRT, however, appeared to be somewhat more
efficacious.
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Reference A3-6
Henry JA, McMillan G, Dann S, Bennett K, Griest S, Theodoroff S, Silverman SP, Whichard S, Saunders G. Tinnitus
Management: Randomized Controlled Trial Comparing Extended-Wear Hearing Aids, Conventional Hearing Aids,
and Combination Instruments. J Am Acad Audiol. 2017 Jun;28(6):546-561.
1) Objective The purpose was to systematically determine the relative efficacy of conventional receiver-
in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and
extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a
randomized controlled trial.
2) Population 19 listeners with hearing impairment, average age of 64 (ranging from 54 to 75 yrs)
3) Performance A ‘‘clinically significant’’ improvement in reaction to tinnitus (at least 13-point reduction in TF
score) was seen by 67% of HA, 82% of EWHA, and 79% of HA1SG participants. There were no
statistically significant differences in the extent to which the devices reduced TFI scores.
there is a compelling contribution for the indication.
In general, this study supports the premise that amplification, with and without an SG, is
beneficial for relief of tinnitus for individuals who have hearing loss. There is insufficient
evidence to conclude that any of these devices offers greater relief
from tinnitus than any other one tested.

Reference A3-12
Henry JA, Frederick M, Sell S, Griest S, Abrams H. Validation of a novel combination hearing aid and tinnitus therapy
device. Ear Hear. 2015 Jan;36(1):42-52.
1) Objective The purpose of this study was to collect initial data addressing whether combination
instruments are more effective for tinnitus management than hearing aids alone.
2) Population 15 listeners with hearing impairment average age of 66,5 yrs
3) Performance Both groups revealed significant improvement, as indicated by reductions in mean TFI index
scores. Differences between groups at 3 months were not statistically significant.
there is a strong contribution for the indication
Results suggest that the use of hearing aids alone or hearing aids plus the use of sound
generators both provide significant benefit with respect to alleviating effects of tinnitus. A
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larger controlled clinical trial is needed to obtain more definitive results regarding the two
configurations of hearing aids.
Reference A3-13
dos Santos GM, Bento RF, de Medeiros IR, Oiticcica J, da Silva EC, Penteado S. The influence of sound generator
associated with conventional amplification for tinnitus control: randomized blind clinical trial. Trends Hear. 2014 Jul
23;18
1) Objective The aim of this study was to verify whether the combined use of amplification and sound
generator is more effective than conventional amplification alone in reducing tinnitus
annoyance
2) Population 49 listeners with hearing impairment average age of 72,1 yrs (ranging from 26 to 91 yrs)
3) Performance Results showed that 62.5% of the patients presented a reduction in tinnitus annoyance in the
combined fitting group and in the group with amplification alone, 78% showed a reduction.
This difference between the groups was not statistically significant.
there is a strong contribution for the indication
it was concluded that the combined use of amplification and sound generator and the use of
conventional amplification alone were equally effective in reducing the discomfort caused by
tinnitus in patients with tinnitus and mild to moderate bilaterally symmetrical sensorineural
hearing loss.

Additional references related to risk-benefit discussion (added to rev.4.0)
Reference # A3-01,
Johnson EE. Safety limit warning levels for the avoidance of excessive sound amplification to protect against further
hearing loss. Int J Audiol. 2017 Nov;56(11):829–836.
1) Objective The study investigated the safe output sound pressure levels (SPL) for sound amplification to
preserve hearing sensitivity when using hearing aids depending on the hearing threshold
expressed by the 4 frequency pure tone average PTA4 (FA4) in dB HL for 0.5, 1, 2 and 4 kHz
for adults.
2) Population Audiograms from the better ear of N = 234 children who participated in the Longitudinal
Outcomes of Children with Hearing Impairment (LOCHI) study (Ching et al, 2013b) using them
as representative audiograms to apply generic prescriptive amplification rationales for adults.
3) Performance Design: A mathematical model consisting of the Modified Power Law (MPL) combined with
equations for predicting temporary threshold shift TTS and subsequent permanent threshold
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shift PTS was used to determine the safe output SPL expressed as RMS level for the risk of
3.5 dB HL PTS following an exposure to that level over at least 8 hours per day. This RMS
levels for safe output SPL were then compared with the output SPL for 80 dB input levels
generated by hearing aid gain expressed as RMS levels following generic prescriptive
amplification rationales for adults for the given hearing loss. The hearing loss was
determined as 4 frequency pure-tone average in dB HL in 5 dB steps from 0 dB HL (normal
hearing) to 120 dB HL (profound hearing loss).
The results of the mathematical model investigation showed that PTS theoretically can, on
rare occasion, occur as a result of output SPL delivered by the hearing aid for high input
levels if prescriptive levels for 80 dB input are exceeded by manual adjustment and the sound
scape experienced by the hearing aid user is consequently delivering high input levels over
the whole day. It could also be shown that the safe output SPL calculated by the model is
depending on the hearing threshold. Better hearing thresholds lowered the safe output level
(e.g. 90 dB SPL RMS for 0 dB HL PT4 threshold), increasing hearing loss raised the safe output
level for long-term use consequently (e.g. 136 dB SPL RMS for 120 dB HL PTA4 threshold).
Prescriptive gain/output calculation for 80 dB input delivered RMS levels below safe output
SPL level for hearing losses up to 75 dB. For PTA4 hearing losses from 80 dB HL to 120 dB HL
the RMS output levels come close to or are the same as the mathematical modelled safe
output SPL describe for the hearing loss.
4) Risk (safety) Safe output SPL can consider the magnitude of unaided hearing loss. For devices not set to
prescriptive levels, limiting the output SPL below the safe levels identified should protect
against threshold worsening as a result of long-term usage.
5) Conclusion The appraisal for evaluating the relevance of this publication described in Table 76 above,
cannot be applied to this study as no humans and no hearing aid devices are involved.

The study shows the hearing aid output calculated based on prescriptive fitting formulas,
used to ensure performance of individually fitted hearing aids, for 80 dB input levels for
adults is safe.

Safety issues were addressed in the paper and tangible recommendations were made on
how to ensure safe output levels of hearing aids.
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Reference # A4-01,
Lopez-Poveda EA; Johannesen PT; Pérez-González P; Blanco JL; Kalluri S; Edwards B. Predictors of Hearing-
Aid Outcomes. Trends in Hear. 2017 Aug; (21):1-28.
1) Objective The study investigated a selection of 19 out of 28 measured variables as factors that may be
useful as possible predictors of hearing aid outcomes to evaluate their portion in predicting
the individual benefit of hearing aid amplification according to speech intelligibility in noise
which is the most sought-after improvement among hearing aid users and its huge variance
in user satisfaction reported from the market.
2) Population N = 68 hearing aid users or candidates with symmetrical sensorineural hearing loss were
fitted bilaterally with non-linear hearing aids receiver-in-the-canal (RITE) style with custom
molds following the fitting protocol from BSA (British Society of Audiology, 2011).
3) Performance Results have shown that none of the investigated 19 predictors and no clinically relevant
combination of them can fully explain the huge variance in user satisfaction when focusing
on the prediction of speech understanding in noise. However, it could be concluded that
intelligibility in non-static noise tends to improve by increasing amplification and therefore
audibility for soft and conversational speech levels should be ensured. The SII in quiet (SIIQ) is
significantly correlated with the Speech Reception Threshold in Noise (SRT_N) and explains
about 16% of the variance of outcomes. Supra-threshold temporal processing deficits is the
most limiting factor, while the unaided Speech Reception Threshold SRTQ in quiet turned out
to be the best clinical predictor for speech understanding in noise. Hearing aid users that
report a better baseline (unaided) hearing abilities tend to report greater benefits from using
hearing aids and hearing aid users with better working memory capacity tend to report
smaller improvement from using hearing aids, although both relationships are weak, this may
explain the impact of the hearing aid users age on the prediction of hearing aid outcome.
Pure-tone thresholds PTT, audibility measured by REIG65dB and REIG50dB used to calculate SIIQ,
SRTQ and self-reported hearing aid benefit from the Speech, Spatial and Quality SSQ
questionnaire and the International Outcome Inventory for Hearing Aids IOI-HA are clinical
measures that can support the prediction of HA outcome. The IOI-HA showed a significant
correlation with the SIIQ.
4) Risk (safety) No risk identified in the use of this device.
5) Conclusion As seen in Table 76 above, compounded weight W for the study was 1,0 In other words,

The study shows factors to predict the user benefit from the hearing aid use, that can be
clinically applied to support the evidence of hearing aid use benefit over all even if there is
still a substantial remaining variance in individual user performance and benefit.

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Reference # A4-01,
Lopez-Poveda EA; Johannesen PT; Pérez-González P; Blanco JL; Kalluri S; Edwards B. Predictors of Hearing-
Aid Outcomes. Trends in Hear. 2017 Aug; (21):1-28.
1) Objective The study investigated a selection of 19 out of 28 measured variables as factors that may be
useful as possible predictors of hearing aid outcomes to evaluate their portion in predicting
the individual benefit of hearing aid amplification according to speech intelligibility in noise
which is the most sought-after improvement among hearing aid users and its huge variance
in user satisfaction reported from the market.
2) Population N = 68 hearing aid users or candidates with symmetrical sensorineural hearing loss were
fitted bilaterally with non-linear hearing aids receiver-in-the-canal (RITE) style with custom
molds following the fitting protocol from BSA (British Society of Audiology, 2011).
3) Performance Results have shown that none of the investigated 19 predictors and no clinically relevant
combination of them can fully explain the huge variance in user satisfaction when focusing
on the prediction of speech understanding in noise. However, it could be concluded that
intelligibility in non-static noise tends to improve by increasing amplification and therefore
audibility for soft and conversational speech levels should be ensured. The SII in quiet (SIIQ) is
significantly correlated with the Speech Reception Threshold in Noise (SRT_N) and explains
about 16% of the variance of outcomes. Supra-threshold temporal processing deficits is the
most limiting factor, while the unaided Speech Reception Threshold SRTQ in quiet turned out
to be the best clinical predictor for speech understanding in noise. Hearing aid users that
report a better baseline (unaided) hearing abilities tend to report greater benefits from using
hearing aids and hearing aid users with better working memory capacity tend to report
smaller improvement from using hearing aids, although both relationships are weak, this may
explain the impact of the hearing aid users age on the prediction of hearing aid outcome.
Pure-tone thresholds PTT, audibility measured by REIG65dB and REIG50dB used to calculate SIIQ,
SRTQ and self-reported hearing aid benefit from the Speech, Spatial and Quality SSQ
questionnaire and the International Outcome Inventory for Hearing Aids IOI-HA are clinical
measures that can support the prediction of HA outcome. The IOI-HA showed a significant
correlation with the SIIQ.
5) Conclusion As seen in Table 76 above, compounded weight W for the study was 1,0 In other words,

The study shows factors to predict the user benefit from the hearing aid use, that can be
clinically applied to support the evidence of hearing aid use benefit over all even if there is
still a substantial remaining variance in individual user performance and benefit.

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Reference # A4-17
Folkeard P, Saleh H, Glista D, Scollie S. Fit-to-target and SII Normative Data for DSL v5.0 adult fittings. 2018 Aug;
Poster Session at IHCON
1) Objective The purpose of this ongoing study is to measure the range of deviation from DSL v5.0 target
for adult fittings, and to generate normative ranges for aided SII for these fittings.
2) Population Real-ear measurement results from modern hearing aids fitted to DSL v5.0 adult targets to
N =281 adult ears fitted within 2016 and 2018 were reviewed in a retrospective chart review.
3) Performance The fit-to-target results were first evaluated by calculating the root mean square error RMSE
for deviation from target by speech input level for soft (55 dB SPL), average (65 dB SPL) and
loud (75 dB SPL), using the frequencies 500, 1000, 2000 and 4000 Hz. Average RMSE across
all three levels was 4 dB with SD= 2,24 dB. The fit-to-target varied by the degree of hearing
loss express by the pure-tone average PTA 4 as well as by the configuration of the hearing
loss and by the hearing aid style. Speech Intelligibility Index SII (ANSI S3.5-1997, R2017)
scores were extracted and plotted against PTA4 to obtain normative ranges per input level.
The trendlines derived describes typical performance ranges for 74-80% of the variance of
the data. Range are imposed around + 1.96 SD to -1 SD of the SII mean value and
extrapolated to cover 0-120 dB HL PTA4.
With modern hearing aids, the fit to target for frequencies from 500-4000 Hz is achievable for
hearing losses with PTA4 of <85 dB HL. Above that range, there is more variability in the
fittings.

The study shows that a fit-to-target for the DSL v5.0 prescriptive amplification rationale for
adults is possible within 6.1 (7.3) dB RMSE for 80% (95%) of the adult population at all test
levels. The aided SII values for speech input levels at 55 dB, 65 dB and 75 dB have been
calculated from the available retrospective data analysis to establish a normative range for
aided SII values per input level referenced to the hearing loss expressed in a PTA4 dB HL
level. The SII normative ranges can be used to assess the quality of individual hearing aid
fitting for adults according to audibility and speech intelligibility.

Reference # A4-25
Baker S, Jenstad L. Matching real-ear targets for hearing aid fittings: NAL-NL1 and DSL v5.0 prescriptive formulae.
CJSLPA 2017 41(2): 227-235
1) Objective This study investigated how far it is possible to match prescriptive amplification targets for
sensorineural mild to profound hearing losses including both new and experienced hearing
aid users when fitting modern hearing aids using real-ear measurements.
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2) Population N = 100 ears were assessed with DSL v5.0 and N = 134 ears with NAL-NL1 prescriptive
amplification rationale.
3) Performance Hearing loss was assessed by using insert earphones and measuring the RECD of each ear to
take the ear canal size into account for precision of hearing loss determination. Hearing aids
from 7 manufacturers covering all HA styles were fitted and verified using speech standard
signal male voice in three input levels (55, 65, 75 dB SPL) from Verifit. Fine-tuning was
applied to match target at least within ±5 dB on the individual ear. Additionally, the aided
Speech Intelligibility Index SIIaided was registered for the three speech input levels. Finally,
hearing loss was categorized by the pure-tone average from 3 frequencies (500, 1000 and
2000 Hz) PTA3 following the categories from ASHA in mild, moderate, moderate-severe and
severe/profound and the mean SIIaided for each speech level, both fitting rationales and each
of the 4 hearing loss categories was calculated and shown with its standard deviation SD.
Results indicate that a modern hearing aid can be matched to target within ± 5 dB regardless
of gain adjustment handles, the manufacturer, or style; with the exception of
severe/profound hearing loss, particular in the high frequencies.

The study shows that a fit-to-target using NAL-NL1 or DSL v5.0 using real-ear measurement
on individual ears is possible within ± 5 dB for modern hearing aids of all styles with some
exceptions for severe/profound hearing losses in the high frequencies. Mean aided SII values
for soft, normal and loud speech levels have be calculated for the 4 hearing loss categories
defined by the PTA3 and can be used to evaluate the quality of the individual fitting regarding
audibility ensuring speech intelligibility

Reference C4-01
McCreery R; Walker E; Spratford M; Kirby B; Oleson J; Brennan M. Stability of Audiometric Thresholds for Children
with Hearing Aids Applying the American Academy of Audiology Pediatric Amplification Guideline: Implications for
Safety. J Am Acad Audiol. 2016 Mar;27 (3): 252–263.
1) Objective The purpose of the study was to compare predicted asymptotic threshold shifts ATS
(frequency dependent PTS) for children from amplification for 80 dB high input levels
calculated by use of the Modified Power Law to the longitudinal behavioral thresholds seen in
a large group of children who wear hearing aids to determine the likelihood of amplification
induced hearing loss.
2) Population N = 213 children with mild to profound hearing loss (PTA4 from 5 to 120 dB HL), average age of
44,1 ± 17,2 months (3.7 ± 1,4 years) at first visit of the longitudinal study.
3) Performance Behavioral audiometric thresholds, hearing aid outputs and hearing aid use data were
collected for each subject across 4 study visits following an accelerated longitudinal study
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design. Individual ear- and frequency-specific safety limits were derived based on the Modified
Power Law to determine the level at which increased amplification could result in permanent
threshold shifts. The changes in behavioral audiometric thresholds corrected by the individual
measured real-ear-to-coupler difference RECD to take the growth of the ear canal over time
into account was monitored and compared for children who were wearing hearing aids with
output levels above and below the safety limits.
Behavioral thresholds decreased across study visits for all children, regardless of whether their
amplification was above the safety limits or not. The magnitude of threshold change across
time corresponded with the changes in the ear canal acoustics as measured by the RECD. It is
concluded that the Modified Power Law predictions of threshold shift overestimated the risk
of excessive output levels for children who wear hearing aids.
4) Risk (safety) No risk identified in the use of this device, even for children who received output levels above
the safety limits indicated by the Modified Power Law.
there is a positive contribution for the indication

The study shows that the long-term use of hearing aids by children fitted according to DSL v5.0
pediatric does not introduce a risk of amplification induced hearing loss. The Modified Power
Low used for estimation of safety limits expressed by frequency-specific SPL output levels
overestimates the risk of amplification induced hearing loss for children who wear hearing
aids.
Safety issues were addressed in the paper showing that following clinical best-practice in
fitting hearing aids to children is providing safe output levels.
Reference A5-001
Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99
1) Objective The Speech, Spatial and Qualities of Hearing Scale (SSQ) is designed to measure a range of
hearing disabilities across several domains. The purpose of the study was to assess the
relationship of the SSQ domains and outcomes to the degree of handicap experienced by a
person whose hearing is impaired.
2) Population N = 153 new clinic clients of average age 71 ± 8,1 years with a better ear hearing loss of
average 38,8 (SD 15,5) dB HL over the frequencies of 500, 1000, 2000 and 4000 Hz. The
worse ear average was 52,2 (SD 24,4) dB HL prior to first-time hearing aid fitting.
3) Performance Mean values and standard deviations for each of the 49 questions from the SSQ have been
derived from the assessment of 153 clinic clients answering SSQ and the the point-scaled
handicap questionnaire. The handicap score was assessed with a 12-item, five-point-scaled
handicap questionnaire which was in part derived from items in the Hearing Disabilities and
Handicaps Scale (Hétu et al, 1994), and from items in an unpublished general health scale
(the Glasgow Hearing Health Status Inventory).
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The average score over all items of the SSQ was 5,5 (SD 1,9) and the average handicap score
was 49,0 (SD 23,9). Norm data and the standard deviation has also been derived from these
outcome measures for each of the 49 questions from the SSQ.
The correlation of the SSQ to the better-ear handicap was -0,51 and to the worse-ear -0,52.
The overall correlation was -0,61. Although there are good correlations between impairment
(threshold) and disability (SSQ), and between disability and handicap, the link between
impairment and handicap is slight.
5) Conclusion The appraisal for evaluating this publication described in Table 76 above, cannot be applied
to this study as no hearing aid devices were involved (pre-fitting study).
The study delivered mean average scores and SD for all SSQ49 questions overall on a
question specific level without amplification. The correlation to hearing impairment as
handicap has been investigated.

Reference A5-057
Noble W, Gatehouse S. Effects of bilateral versus unilateral hearing aid fitting on abilities measured by Speech,
Spatial, and Qualities of Hearing Scale (SSQ). Int J Audiol. 2006 Mar;45(3):172-81
1) Objective The study investigated the handicap and the SSQ49 questionnaire self-reported outcome in
the context of three independent different clinical groups representing no experience with
hearing aid amplification, 6-month experience with unilateral amplification and 6-months
experience with bilateral amplification.
2) Population N = 144 people prior fitting with amplifications, N = 118 people with six months experience
with unilateral amplification and N = 42 people with six months experience with bilateral
amplification. The hearing loss ranged from 45,4 (SD 8,1) dB HL to 54,9 (SD 13,5) dB HL on the
better ear and from 59,9 (SD 20,3) to 72 (SD 19,4) dB HL in the worse ear.
3) Performance The pre-fit handicap was assessed with the Glasgow Hearing Aid Benefit Profile while using the
Handicap Scale from Gatehouse and Noble (2004) to assess the post-fit handicap. The hearing
loss was quantified by using the 4-frequency average PTA4 at 500, 1000, 2000 and 4000 Hz for
the better and the worse ear. SSQ49 mean values were derived for the unaided (pre-fit), the
unilaterally aided and the bilateral aided conditions. The contrasts between unaided,
unilateral and bilateral listing in 10 domains covered by the SSQ were analyzed to identify
significant benefit for unilateral over unaided, bilateral over unaided and bilateral over
unilateral aided conditions.
Result: It has been identified that two hearing aids offer advantage in demanding and dynamic
contexts; these contexts are argued as significant in the maintenance of social competence
and emotional well-being.
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In demanding and dynamic listening conditions the bilateral hearing aid amplification offers a
clear advantage. Results from specific questions in the SSQ49 questionnaire support that.
Significant improvement for maintenance of social competence and emotional well-being of
the hearing impaired could be associated with bilateral hearing aid fitting.

Reference A5-022
Abrams HB, Chisholm TH, McArdle R. Health-Related Quality of Life and Hearing Aids: a Tutorial. Trends Amplif.
2005;9(3):99-109
1) Objective This tutorial reviews the conceptual framework of health-related quality-of-life (HRQoL),
including the challenges associated with defining and measuring HRQoL, specifically as it
applies to audiological care.
2) Population N/A
3) Performance The absence of hearing-related questions on most commonly used health status
questionnaires has made it difficult to demonstrate the effect of treatment for adult-onset
hearing impairment on generic HRQoL. As a consensus, disease-specific questionnaires have
been recommended besides generic assessment of HRQoL to investigate the benefit of
hearing aid treatment and the change in Quality-of-Life QoL. The Abbreviated Profile of
Hearing Aid Benefit (APHAB) (Cox and Alexander, 1995) and the Hearing Aid Handicap
Inventory for Elderly (HHIE) (Ventry and Weinstein, 1982) have been used and both
instrument have been shown to be responsive to hearing aid intervention (e.g. Chisholm and
Abrams, 2001; Humes et al., 1996). WHO developed the World Health Organizations
Disability Assessment Schedule II (WHO-DAS II) as a new generic profile-type questionnaire to
address the need for a multi-dimensional instrument that includes items loading on the
consequences of hearing impairment.
Conclusion: Audiologist have a variety of disease-specific instruments available that have

been useful in evaluating and documenting the results of hearing aid intervention. Still, they
need to move beyond these established instruments and demonstrate their work has a
positive impact on overall HRQoL. The WHO-DAS II has the potential for being a generic
HRQoL for audiology and large-scale studies need to be applied to deliver evidence for that.
5) Conclusion The appraisal for evaluating the relevance of this publication described in Table 76 above,
cannot be applied to this study as no humans and no hearing aid devices are involved.
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The publication discusses the needs for tools to assess the health-related quality of life
HRQoL related to hearing impairment and the change by technical treatment. The APHAB
and the HHIE are disease-specific instruments that have been shown to be responsive to
hearing aid intervention.

Reference # A6-14
Johnson JA, Cox MC, Alexander GC. Development of APHAB norms for WDRC hearing aids and comparisons with
original norms. Ear Hear. 2010 Feb;31(1):47-55.
1) Objective The study had two purposes: First, to provide a comparison of subjective performance and
benefit measured with the APHAB questionnaire comparing the outcome achieved by a
group of hearing-impaired using 1990s-era linear processing hearing aids to a group using
more current WDRC hearing aids. Second, to determine if APHAB norms derived from scores
for WDRC hearing aids were different from the original 1995 norms.
2) Population N = 154 hearing-impaired individuals aged 60 years or older who had been fitted bilaterally
with WDRC hearing aids of all styles and used them between 6-18 months returned
competed APHAB questionnaires
3) Performance Norms were generated from data delivered by all successful WDRC hearing aid users and
compared with the original 1995 norms of the APHAB. Differences between both data sets of
norms were minimal for the speech communication subscales. However, the WDRC
technology users reported less frequent difficulties with sound aversiveness in the aided
condition showing that compression capabilities of WDRC hearing aids have resulted in less
negative reactions to environmental sounds.
The 2005 norms for APHAB should be used when obtaining baseline (unaided performance)
and hearing aid outcome (aided performance) measures for individuals using wide-dynamic
range compression (WDRC) technology in hearing aids.

Norm data for the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaires were
updated to be representative for nonlinear wide dynamic-range compression WDRC hearing
aid technology.

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Clinical Evaluation Report

Title: Document No. Revision No. Page No.

Clinical Evaluation Report for

Name Title/Role & Function Signature Date

Christina Degn Frary Clinical Audiologist, CAU CHNF 2020-12-14

Lars Bramsløw Audiological Researcher/ERH LABW 2020-12-14

Joanna Rzędzian Clinical Audiologist/SWS JOZD 2020-12-14

Eva Andreasson Clinical Audiologist/SWS EVAA 2020-12-14

Dragan Gusatovic Clinical Audiologist/CAU DRGU 2020-12-14

Louise Würtz Jørgensen Regulatory Affairs Manager/ LOUJ 2020-12-14

Name Title/Role & Function Signature Date

Regulatory Affairs Project

Henrik Lodberg Olsen Clinical Audiologist/CAU HEOL 2020-12-14

Monika Baumann Clinical audiologist, PMCF MOBM 2020-12-14

Name Title/Role & Function Signature Date

Thomas Behrens Chief of Audiology, Oticon THBE 2020-12-15

Template for: Clinical Evaluation Report, 888 18 001 Rev. 3.0

Template for: Clinical Evaluation Report, 888 18 001 Rev. 3.0

Revision No. Date Writer Change

1.0 2020-09-10 LBHA Document created on behalf of CHNF

Template for: Clinical Evaluation Report, 888 18 001 Rev. 3.0

Template for: Clinical Evaluation Report, 888 18 001 Rev. 3.0

Template for: Clinical Evaluation Report, 888 18 001 Rev. 3.0

2.3.2 Mechanical design .......................................................................................................................... 21

2.3.3 Principles of operation .................................................................................................................... 23

2.3.4 Key technical features .................................................................................................................... 25

2.3.5 Hearing aid material (biological safety) .......................................................................................... 25

2.3.6 Device design history ...................................................................................................................... 28

2.3.1 Number of devices on the market ................................................................................................... 30

Expected lifespan ............................................................................................................. 37

Template for: Clinical Evaluation Report, 888 18 001 Rev. 3.0

2.13.1 Fitting software Genie 2 .................................................................................................................. 41

2.13.1 Oticon RemoteCare App (optional)................................................................................................. 48

2.13.2 Oticon ON App (optional) ................................................................................................................ 50

2.13.3 Oticon Charger................................................................................................................................ 51

2.13.4 Oticon TV adapter (optional)........................................................................................................... 54

2.13.5 Oticon Phone Adapter 2.0 (optional) .............................................................................................. 55

2.13.6 Oticon ConnectClip (optional) ......................................................................................................... 56

2.13.7 Oticon EduMic (optional) ................................................................................................................ 57

3.1.2 User Groups and treatments options .............................................................................................. 75

3.1.3 Hearing aids .................................................................................................................................... 77

3.1.4 Hearing aid description ................................................................................................................... 81

3.1.5 Hearing aid fitting management ...................................................................................................... 81

3.1.6 Hearing Aid Performance and benefit ............................................................................................ 87

3.2.2 User Groups and treatments options .............................................................................................. 90

3.2.3 Therapeutic options ........................................................................................................................ 90

3.2.4 Sound therapy................................................................................................................................. 93

3.2.5 Tinnitus management ..................................................................................................................... 96

3.2.6 Audiological approaches to sound therapy ..................................................................................... 99

3.2.7 Sound therapy support performance and benefit ......................................................................... 101

Identification of pertinent data and appraisal criteria used .................................................. 103

Template for: Clinical Evaluation Report, 888 18 001 Rev. 3.0

3.5.2 Tinnitus ......................................................................................................................................... 106

Clinical risks associated with the device ............................................................................. 107

5.2.2 Device under evaluation ............................................................................................................... 112

Clinical Data of Tinnitus SoundSupport feature .................................................................. 115

Post-market clinical follow-up data ..................................................................................... 123

5.6.2 TGA search ................................................................................................................................... 139

5.6.3 MHRA search................................................................................................................................ 140

5.6.4 Health Canada search .................................................................................................................. 140

5.6.5 BfArM Search................................................................................................................................ 140

5.6.6 Summary ....................................................................................................................................... 141