AJA
Research Article
Efficacy of Intratympanic Steroid on
Idiopathic Sudden Sensorineural Hearing
Loss: An Analysis of Cases With Negative
Prognostic Factors
Hideaki Suzuki,a Rintaro Kawaguchi,a Tetsuro Wakasugi,a Ba Hung Do,a
Takuro Kitamura,a and Toyoaki Ohbuchia
Purpose: We retrospectively studied the efficacy of
intratympanic steroid administration in comparison with
hyperbaric oxygen (HBO) therapy for idiopathic sudden
sensorineural hearing loss (ISSNHL) with negative
prognostic factors.
Method: We enrolled 301 patients (302 ears) with ISSNHL
(average hearing level at 250–4000 Hz ≥ 40 dB; time from
onset to treatment ≤ 30 days). From August 2002 to March
2009, 174 patients (174 ears) received systemic steroid
plus HBO therapy (HBO group), and from June 2015 to
January 2018, 127 patients (128 ears) received systemic
plus intratympanic steroid (IT group). Hearing outcomes
were evaluated by 6 indices: cure rate, marked-recovery
rate (percent of patients with hearing gain ≥ 30 dB),
recovery rate (percent of patients with hearing gain ≥
10 dB), hearing gain, hearing level after treatment, and
A
mong many regimens for the treatment of idio-
pathic sudden sensorineural hearing loss (ISSNHL),
intratympanic steroid administration has attracted
attention for the past 2 decades (Lavigne, Lavigne, & Saliba,
2016). According to the clinical practice guideline of the
American Academy of Otolaryngology—Head and Neck
Surgery, salvage intratympanic steroid administration is
recommended, whereas systemic steroid use and hyperbaric
oxygen (HBO) therapy remain mere options for the treat-
ment of ISSNHL (Stachler et al., 2012).
a
Department of Otorhinolaryngology—Head and Neck Surgery,
School of Medicine, University of Occupational and Environmental
Health Japan, Kitakyushu
Correspondence to Hideaki Suzuki: suzuhyde@med.uoeh-u.ac.jp
Editor-in-Chief: Sumitrajit Dhar
Editor: Ann Eddins
Received May 25, 2018
Revision received September 9, 2018
Accepted December 12, 2018
https://doi.org/10.1044/2018_AJA-18-0085
American Journal of Audiology • 1–7 • Copyright © 2019 American Speech-Language-Hearing Association
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percent hearing improvement compared to the unaffected
contralateral ear.
Results: The recovery rate was significantly higher in the IT
group than in the HBO group (80.5% vs. 68.4%, p = .019).
The IT group showed a higher recovery rate than the HBO group
in patients aged ≥ 60 years ( p = .010), patients with early
(≤ 7 days from onset) treatment (p = .005), patients with initial
hearing levels ≥ 90 dB ( p = .037), and patients with vertigo/
dizziness (p = .040). The IT group also showed higher hearing
gain and percent hearing improvement than the HBO group in
patients with vertigo/dizziness (p = .046 and p = .026, respectively).
Conclusions: Systemic plus intratympanic steroid is more
effective for ISSNHL than systemic steroid plus HBO,
particularly in patients with negative prognostic factors,
such as old age, profound hearing loss, and/or presence
of vertigo/dizziness.
A number of authors have documented the usefulness
of intratympanic steroid administration as a primary and
salvage treatment for ISSNHL (Lavigne et al., 2016). At our
institute, we had previously performed systemic steroid +
HBO, which was effective to a certain extent. Aiming at a
better hearing outcome, we changed our regimen and started
systemic + intratympanic steroid administration in 2009. As
a result, the latter regimen turned out to be more effective
(Suzuki et al., 2012). Since then, we have tested three differ-
ent protocols of intratympanic steroid injections: four rounds
of once-weekly injection (Suzuki et al., 2012), four injec-
tions in a single week (Suzuki et al., 2016), and two injec-
tions on the first 2 days (Suzuki et al., 2018). We found that
the simplest two-injection protocol is still sufficiently effec-
tive, and therefore, we have been continuing the two-injection
protocol up to the present. However, it is still difficult to
treat some specific cases with negative prognostic factors.
Several prognostic factors for hearing outcomes in
ISSNHL have been reported: older age, longer period from
Disclosure: The authors have declared that no competing interests existed at the time
of publication.
1
onset, more severe initial hearing loss, and association with
vertigo/dizziness are well-known negative prognostic fac-
tors (Suzuki et al., 2011). In this study, we retrospectively
analyzed the efficacy of intratympanic steroid adminis-
tration in comparison with HBO therapy in patients with
such negative prognostic factors. This study would provide
helpful information for audiologists to understand the ef-
fectiveness of intratympanic steroid administration for the
treatment of ISSNHL and to determine the indication of
this therapy.
Method
Patients
We retrospectively analyzed 301 patients (302 ears)
with ISSNHL who were treated in our department. We de-
fined ISSNHL according to previous studies as follows
(Suzuki et al., 2012): (a) patients have sudden-onset senso-
rineural hearing losses, and (b) the cause of hearing loss is
unknown. In addition, we also set inclusion and exclusion
criteria for the indication of our treatment protocol. The
inclusion criteria were (c) the arithmetic mean of the hear-
ing levels at 250, 500, 1000, 2000, and 4000 Hz is ≥ 40 dB;
and (d) the time from the onset of hearing loss to the start
of treatment is ≤ 30 days. The exclusion criteria were (a) pa-
tients have diabetes mellitus (DM) complicated with severe
nephropathy/retinopathy/neuropathy, severe peptic ulcer
and/or viral hepatitis, and/or (b) patients do not accept our
treatment protocol.
Informed consent was not obtained from participants
because the study was a retrospective review of patients’
clinical records and the information was anonymized and
de-identified prior to analysis. This study was approved by
the Review Board of the University of Occupational and
Environmental Health.
Treatment Protocols
From August 2002 to March 2009, 174 consecutive
patients (174 ears) received systemic steroid plus HBO
therapy (HBO group). Systemic steroid administration was
started with 400-mg iv hydrocortisone sodium succinate
for 3 days followed by tapered doses, as shown in Table 1.
HBO therapy was performed in a hyperbaric chamber,
where the patients breathed 100% oxygen at a pressure of
2.5 atm for 60 min, once daily, from Monday through
Friday for 2 weeks (a total of 10 sessions).
From June 2015 to January 2018, 127 consecutive
patients (128 ears) received systemic plus intratympanic
steroid. Systemic steroid administration was started with
100-mg iv prednisolone for 3 days followed by tapered
doses, as shown in Table 1. Intratympanic steroid injection
was performed as follows: Patients underwent myringotomy
and ventilation tube insertion under local anesthesia, and
0.2–0.4 ml of dexamethasone sodium phosphate (4 mg/ml
as dexamethasone phosphoric ester) was injected through
the tube into the tympanic cavity on Days 1 and 2. Pa-
tients were directed to maintain a supine position with
their heads turned 45o to the opposite side for 30 min after
injection. The ventilation tube was removed immediately
after the second injection, and the perforation was covered
with a small sheet of chitin wound dressing (Beschitin W;
UNITIKA).
Evaluation of Hearing
The arithmetic mean of the hearing levels at 250,
500, 1000, 2000, and 4000 Hz was used to evaluate hearing
outcomes. The hearing level at 1–2 months after the com-
pletion of treatment was considered to be fixed (HLpost),
and hearing recovery was classified into one of four grades
(complete recovery, good recovery, fair recovery, and no
change/deterioration) according to the Ad Hoc Committee
of the Japanese Ministry of Health, Labor and Welfare
(see Table 2; Suzuki et al., 2012). The cure rate, marked-
recovery rate, and recovery rate were defined as the percent
of ears with complete recovery, those with complete/good
recovery, and those with complete/good/fair recovery, re-
spectively (Suzuki et al., 2012).
The percent hearing improvement compared to the
unaffected contralateral ear was calculated using the fol-
lowing equation (Suzuki et al., 2016):


%Hearing improvement ¼ HLpre –HLpost

= HLpre –HLcontra  100ð%Þ;
ð1Þ
where HLpre is the initial hearing level and HLcontra is the
hearing level of the unaffected contralateral ear.

Table 1. Protocol of systemic steroid administration.

Day HBO group IT group

1–3 400-mg hydrocortisone sodium succinate (div) 100-mg prednisolone (div)

4–6 200-mg hydrocortisone sodium succinate (div) 50-mg prednisolone (div)
7–9 100-mg hydrocortisone sodium succinate (div) 25-mg prednisolone (div)
10–12 10-mg prednisolone (po) 10-mg prednisolone (po)
13–14 5-mg prednisolone (po) 5-mg prednisolone (po)

Note. HBO group = patients received systemic steroid plus HBO therapy; IT group = patients received systemic
plus intratympanic steroid; div = intravenous drip infusion; po = peroral administration.

2 American Journal of Audiology • 1–7

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Table 2. Criteria for hearing recovery in idiopathic sudden
sensorineural hearing loss.a
Complete recovery: Hearing level returns to within 20 dB at 250,
500, 1000, 2000, and 4000 Hz, or to a level equal to that of the
unaffected contralateral ear.
Good recovery: Improvement in the hearing levelb is ≥ 30 dB.
Fair recovery: Improvement in the hearing levelb is ≥ 10 dB but
< 30 dB.
No change/deterioration: Improvement in the hearing levelb is
< 10 dB.
a
As proposed by the ad hoc committee of the Japanese Ministry
of Health and Welfare (Suzuki et al., 2012). bArithmetic mean of
hearing levels at five frequencies (250–4000 Hz).
Statistics
Data were expressed as the mean ± SEM. Differences
in proportions and means between the groups were analyzed
using the χ2 test and two-tailed Student’s t test, respec-
tively. Statistical analyses were performed using the Bell
Curve for Excel Statistics (Social Survey Research Infor-
mation Co). p values < .05 were considered statistically
significant.
Results
Profile of Patients
The profile of patients in each group is summarized
in Table 3. Patients in the HBO group were significantly
younger than those in the IT group. The sex predominance,
interval between the onset and the start of treatment, HLpre,
percent of patients with vertigo/dizziness, and HLcontra did
not differ between the two groups.
Hearing Outcomes
In the HBO group, HLpre was 78.3 ± 2.1 dB and
73.7 ± 2.1 dB in the right and left ears, respectively. HLpost
was 51.0 ± 3.3 dB and 48.3 ± 2.8 dB in the right and left
ears, respectively. In the IT group, HLpre was 78.5 ± 2.5 dB
and 76.5 ± 2.4 dB in the right and left ears, respectively.
HLpost was 50.9 ± 3.3 dB and 47.6 ± 3.0 dB in the right
and left ears, respectively. There was no significant differ-
ence between the right and left ears.
Six hearing indices, specifically, the cure rate, marked-
recovery rate, recovery rate, hearing gain (HLpre–HLpost),
HLpost, and percent hearing improvement were statistically
analyzed for the assessment of hearing outcomes. Hearing
outcomes are summarized in Table 4. The recovery rate
was significantly higher in the IT group than in the HBO
group (80.5% vs. 68.4%, p = .019), whereas the cure rate,
marked-recovery rate, hearing gain, HLpost, or percent hear-
ing improvement did not differ significantly between the
two groups.
Table 5 represents hearing outcomes in patients aged
< 60 years and those ≥ 60 years, separately. In patients
aged ≥ 60 years, the recovery rate was significantly higher
in the IT group than in the HBO group (79.3% vs. 60.8%,
p = .010), whereas the cure rate, marked-recovery rate,
hearing gain, HLpost, or percent hearing improvement did
not differ significantly between the two groups. The percent
hearing improvement tended to be higher in the IT group
than in the HBO group, but the difference did not reach the
level of significance (53.9 ± 4.3% vs. 42.4 ± 4.7%, p = .073).
On the other hand, in patients aged < 60 years, none of the
six hearing indices was significantly different between the
two groups.
Table 6 shows hearing outcomes in patients with early
treatment (interval from the onset to the start of treatment
≤ 7 days) and those with late treatment (interval from the
onset to the start of treatment ≥ 8 days), separately. In pa-
tients with early treatment, the recovery rate was signifi-
cantly higher in the IT group than in the HBO group (88.5%
vs. 72.7%, p = .005), whereas the cure rate, marked-recovery
rate, hearing gain, HLpost, or percent hearing improvement
did not differ significantly between the two groups. On
the other hand, in patients with late treatment, none of the
six hearing indices was significantly different between the
two groups.
Table 7 shows hearing outcomes in patients with
HLpre < 90 dB and those with HLpre ≥ 90 dB, separately.
In patients with HLpre ≥ 90 dB, the recovery rate was sig-
nificantly higher in the IT group than in the HBO group
(83.3% vs. 62.5%, p = .037), whereas the cure rate, marked-
recovery rate, hearing gain, HLpost, or percent hearing im-
provement did not differ significantly between the two

Table 3. Profile of patients.

Profile HBO group IT group p values

Number of ears 174 128

Male/female 81/93 66/62 .389
Age, years 56.0 ± 1.2 61.1 ± 1.4 .005
Days from onset to treatment 6.1 ± 0.4 6.5 ± 0.4 .482
HLpre, dB 75.8 ± 1.5 77.4 ± 1.7 .474
Presence of vertigo 40/174 (23.0%) 39/128 (30.5%) .144
HLcontra, dB 24.2 ± 1.3 25.8 ± 1.1 .394

Note. HBO group = patients received systemic steroid plus HBO therapy; IT group = patients received systemic plus intratympanic steroid;
HLpre = initial hearing level; HLcontra = hearing level of the unaffected contralateral ear.

Suzuki et al.: Intratympanic Steroid for Refractory ISSNHL 3

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Table 4. Summary of hearing outcomes.

Hearing index HBO group IT group p value

Cure rate 29.3% (174) 21.9% (128) .146

Marked-recovery rate 51.7% (174) 49.2% (128) .667
Recovery rate 68.4% (174) 80.5% (128) .019*
Hearing gain 26.2 ± 1.7 dB (174) 28.2 ± 1.9 dB (128) .443
HLpost 49.6 ± 2.1 dB (174) 49.2 ± 2.2 dB (128) .913
%Hearing improvement 51.6 ± 3.2% (172) 55.6 ± 3.5% (127) .413

Note. The %hearing improvement data of two ears in the HBO group and one ear in the IT group are missing because the contralateral ears
in these cases were impaired and HLcontra was considered to be invalid. Numerals in parentheses indicate the number of ears. HBO group =
patients received systemic steroid plus HBO therapy; IT group = patients received systemic plus intratympanic steroid; HLpost = hearing level
at 1–2 months after the completion of treatment.
*Statistically significant.

groups. On the other hand, in patients with HLpre < 90 dB,
none of the six hearing indices was significantly different
between the two groups.
Table 8 represents hearing outcomes in patients with
vertigo/dizziness and those without, separately. In patients
associated with vertigo/dizziness, the recovery rate, hearing
gain, and percent hearing improvement were significantly
higher in the IT group than in the HBO group (76.9% vs.
55.0%, p = .040; 25.4 ± 3.2 dB vs. 16.6 ± 2.9 dB, p = .046;
44.8 ± 5.4% vs. 28.4 ± 4.8%, p = .026), whereas the cure
rate, marked-recovery rate, or HLpost did not differ signifi-
cantly between the two groups. On the other hand, in pa-
tients without vertigo/dizziness, none of the six hearing
indices was significantly different between the two groups.
These results indicate that systemic plus intratympanic
steroid is more effective than systemic steroid plus HBO
for ISSNHL, particularly in cases with negative prognostic
factors, such as old age, profound hearing loss, and/or
presence of vertigo/dizziness.
Adverse Events
Twelve patients (6.9%) in the HBO group underwent
myringotomy due to acute otitis media/otitis media with
effusion. Of 124 ears with follow-up periods ≥ 2 months
after the completion of treatment in the IT group, perfora-
tion of the tympanic membrane remained in five ears (4.0%),
but no one underwent myringoplasty. Insulin was introduced
and/or increased due to the elevation of the blood glucose
level in 24 patients (68.6% of 35 patients with DM) in the
HBO group and in 35 patients (79.5% of 44 patients with
DM) in the IT group. There was no patient who developed
severe peptic ulcer or aggravation of hepatitis.
Discussion
In this study, first, we confirmed that the recovery
rate was higher in the IT group than in the HBO group,
consistent with our previous study (Suzuki et al., 2012).
Patients in the HBO group were about 5 years younger in
average than those in the IT group (see Table 3). The reason
for this is unclear. It may be partially explained by the nation-
wide aging of our country including our district because
the study period for the HBO group was about 10 years
earlier than that for the IT group. Old age is generally
thought to be a negative prognostic factor for ISSNHL,
and therefore, younger age in the HBO group does not

Table 5. Hearing outcomes in patients aged < 60 years and those ≥ 60 years.

< 60 years ≥ 60 years

p p
Hearing index HBO group IT group values HBO group IT group values

Cure rate 35.8% (95) 28.3% (46) .374 21.5% (79) 18.3% (82) .608
Marked-recovery rate 61.1% (95) 63.0% (46) .820 40.5% (79) 41.5% (82) .902
Recovery rate 74.4% (95) 82.6% (46) .295 60.8% (79) 79.3% (82) .010*
Hearing gain 31.6 ± 2.4 dB (95) 34.7 ± 3.5 dB (46) .457 19.9 ± 2.3 dB (79) 24.6 ± 2.1 dB (82) .127
HLpost 43.5 ± 2.9 dB (95) 44.1 ± 4.2 dB (46) .913 56.8 ± 3.0 dB (79) 52.1 ± 2.5 dB (82) .232
%hearing improvement 59.3 ± 4.2% (94) 58.4 ± 5.9% (46) .899 42.4 ± 4.7% (78) 53.9 ± 4.3% (81) .073

Note. The %hearing improvement data of three ears (one ear each in the HBO group aged < 60 years, in the HBO group aged ≥ 60 years, and
in the IT group aged ≥ 60 years) are missing because the contralateral ears in these cases were impaired and HLcontra was considered to be
invalid. Numerals in parentheses indicate the number of ears. HBO group = patients received systemic steroid plus HBO therapy; IT group =
patients received systemic plus intratympanic steroid; HLpost = hearing level at 1–2 months after the completion of treatment.
*Statistically significant.

4 American Journal of Audiology • 1–7

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Table 6. Hearing outcomes in patients with early treatment (interval from the onset to the start of treatment ≤ 7 days) and those with late
treatment (interval from the onset to the start of treatment ≥ 8 days).

≤ 7 days ≥ 8 days
p p
Hearing index HBO group IT group values HBO group IT group values

Cure rate 33.3% (132) 28.7% (87) .474 16.7% (42) 7.3% (41) .332
Marked-recovery rate 57.6% (132) 56.3% (87) .856 33.3% (42) 34.1% (41) .938
Recovery rate 72.7% (132) 88.5% (87) .005* 54.8% (42) 63.4% (41) .423
Hearing gain 29.0 ± 2.0 dB (132) 32.4 ± 2.1 dB (87) .260 17.5 ± 3.1 dB (42) 19.3 ± 3.4 dB (41) .693
HLpost 46.8 ± 2.5 dB (132) 45.9 ± 2.7 dB (87) .799 58.2 ± 3.8 dB (42) 56.3 ± 3.8 dB (41) .735
%Hearing improvement 57.3 ± 3.6% (131) 64.1 ± 3.7% (86) .206 33.6 ± 6.1% (41) 37.6 ± 6.8% (41) .660

Note. The %hearing improvement data of three ears (one ear each in the HBO group with early treatment, in the IT group with early
treatment, and in the HBO group with late treatment) are missing because the contralateral ears in these cases were impaired and HLcontra
was considered to be invalid. Numerals in parentheses indicate the number of ears. HBO group = patients received systemic steroid plus
HBO therapy; IT group = patients received systemic plus intratympanic steroid; HLpost = hearing level at 1–2 months after the completion of
treatment.
*Statistically significant.

weaken but rather strengthen the superiority of intratym-
panic steroid over HBO.
The protocol of systemic steroid administration was
different between the two groups, as shown in Table 1.
Because the corticosteroid potency of prednisolone is four
times higher than that of hydrocortisone (Rang, Dale,
Ritter, & Gardner, 1995; Schimmer & Funder, 2011), we
set the dose of prednisolone in the IT group as one fourth
the dose of hydrocortisone in the HBO group. Consequently,
the total potency of systemic steroid was considered to
be equivalent between the two groups. Based on this phar-
macological equivalence, the present results indicate the
superiority of intratympanic steroid over HBO for the
treatment of ISSNHL.
Next, we showed that, in old (≥ 60 years) patients, pa-
tients with early (≤ 7 days from onset) treatment, patients
with profound (≥ 90 dB) hearing loss, and patients associ-
ated with vertigo/dizziness, hearing outcomes were better in
the IT group than those in the HBO group. On the other
hand, in the other patients, hearing outcomes did not differ
between the two groups.
The hearing levels ≥ 90 dB are generally considered
to be profound hearing loss. Wilson, Byl, and Laird (1980)
in their well-known randomized controlled trial have shown
poor hearing prognosis in patients with HLpre ≥ 90 dB. In
addition, ISSNHL with HLpre ≥ 90 dB is categorized into
Grade 4 (profound ISSNHL) by the criteria of the Ad Hoc
Committee of the Japanese Ministry of Health, Labor and
Welfare (Suzuki et al., 2012). We, therefore, set the cutoff
hearing level to 90 dB.
Several studies have investigated the efficacy of intra-
tympanic steroid for severe–profound ISSNHL. Their re-
sults vary considerably. Filipo et al. (2012) and Sevil,
Bercin, Muderris, Gul, and Kiris (2016) conducted
randomized controlled trials and evaluated the efficacy of
intratympanic steroid plus HBO in comparison with systemic
steroid plus HBO. Both of them found that hearing out-
comes were not statistically different between the two groups
regardless of the severity of hearing loss. Other investiga-
tors compared the efficacy of systemic plus intratympanic
steroid with that of systemic steroid alone: A retrospective
trial by Jung, Park, Jang, and Lee (2016) showed that HLpost

Table 7. Hearing outcomes in patients with HLpre < 90 dB and those with HLpre ≥ 90 dB.

< 90 dB ≥ 90 dB
p p
Hearing index HBO group IT group values HBO group IT group values

Cure rate 36.5% (126) 26.1% (92) .104 10.4% (48) 11.1% (36) .799
Marked-recovery rate 56.3% (126) 50.0% (92) .353 39.6% (48) 47.2% (36) .484
Recovery rate 70.6% (126) 79.3% (92) .146 62.5% (48) 83.3% (36) .037*
Hearing gain 26.9 ± 2.0 dB (126) 26.6 ± 2.1 dB (92) .905 24.4 ± 3.2 dB (48) 32.4 ± 3.8 dB (36) .107
HLpost 39.5 ± 1.9 dB (126) 41.6 ± 2.1 dB (92) .465 75.9 ± 3.8 dB (48) 68.6 ± 4.5 dB (36) .215
%Hearing improvement 58.7 ± 3.9% (125) 60.1 ± 4.3% (91) .815 32.7 ± 4.5% (47) 44.0 ± 5.4% (36) .106

Note. The %hearing improvement data in patients of three ears (one ear each in the HBO group with HLpre < 90 dB, in the IT group with HLpre
< 90 dB and in the HBO group with HLpre ≥ 90 dB) are missing because the contralateral ears in these cases were impaired and HLcontra was
considered to be invalid. Numerals in parentheses indicate the number of ears. HBO group = patients received systemic steroid plus HBO
therapy; IT group = patients received systemic plus intratympanic steroid; HLpost = hearing level at 1–2 months after the completion of treatment.
*Statistically significant.

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Table 8. Hearing outcomes in patients with vertigo/dizziness and those without.

Vertigo/dizziness (−) Vertigo/dizziness (+)

p p
Hearing index HBO group IT group values HBO group IT group values

Cure rate 37.3% (134) 28.1% (89) .153 2.5% (40) 7.7% (39) .590
Marked-recovery rate 59.7% (134) 53.9% (89) .394 25.0% (40) 38.5% (39) .198
Recovery rate 72.4% (134) 82.0% (89) .098 55.0% (40) 76.9% (39) .040*
Hearing gain 29.1 ± 2.0 dB (134) 29.5 ± 2.3 dB (89) .905 16.6 ± 2.9 dB (40) 25.4 ± 3.2 dB (39) .046*
HLpost 45.0 ± 2.4 dB (134) 45.2 ± 2.4 dB (89) .954 64.7 ± 4.0 dB (40) 58.3 ± 4.6 dB (39) .294
%Hearing improvement 58.6 ± 3.7% (132) 60.3 ± 4.4% (88) .774 28.4 ± 4.8% (40) 44.8 ± 5.4% (39) .026*

Note. The %hearing improvement data of three ears (two ears in the HBO group without vertigo/dizziness and one ear in the IT group without
vertigo/dizziness) are missing because the contralateral ears in these cases were impaired and HLcontra was considered to be invalid. Numerals
in parentheses indicate the number of ears. HBO group = patients received systemic steroid plus HBO therapy; IT group = patients received
systemic plus intratympanic steroid; HLpost = hearing level at 1–2 months after the completion of treatment.
*Statistically significant.

was better in the systemic plus intratympanic steroid group
than in the systemic steroid group regardless of the severity
of hearing loss. On the other hand, randomized controlled
trials showed different results: Gundogan et al. (2013) re-
ported that the hearing gain was better in the systemic plus
intratympanic steroid group than in the systemic steroid
group in patients with HLpre ≥ 70 dB, whereas, in patients
with HLpre < 70 dB, the hearing gain was equivalent in the
two groups. In contrast, Koltsidopoulos, Bibas, Sismanis,
Tzonou, and Seggas (2013) documented that the hearing
gain and improvement of the speech discrimination score
were better in the systemic plus intratympanic steroid group
than in the systemic steroid group in patients with HLpre
≤ 90 dB, whereas the hearing outcomes were equivalent as
a whole in the two groups.
One of the conclusions the above lines of evidence
suggest is that intratympanic steroid itself is not superior to
systemic steroid, but exerts a synergistic effect when used
in combination with systemic steroid. A possible explanation
for this is that penetration of the intratympanic drug into
the cochlea may not be certain but rather may depend on
the individual variation of the middle ear anatomy, and
concurrent systemic steroid may complement such uncertain
drug transport in intratympanic administration (Suzuki
et al., 2012).
The previous reports (Gundogan et al., 2013; Jung
et al., 2016; Koltsidopoulos et al., 2013) also indicate that
the efficacy and usefulness of intratympanic steroid for
severe–profound ISSNHL are uncertain and controversial.
Our results roughly parallel the finding of Gundogan et al.
(2013), but are rather opposite to those of Koltsidopoulos
et al. (2013). The reason for such conflicting observa-
tions is unclear and remains to be investigated in a future
trial.
In addition to severe–profound initial hearing loss, old
age, late treatment, and association with vertigo are also
negative prognostic factors in ISSNHL. Patients with old
ages exhibit worse hearing outcomes. In previous studies,
cutoff ages between 40 and 60 years were used to show a
difference in hearing outcomes, between the young and old
groups. The cutoff age of 60 years in our study was based
on the report by Lee and Ban (2010). Patients who started
receiving treatment later exhibit worse hearing outcomes.
Generally speaking, 1 week is a convenient period for
clinical work. Several researchers have used a cutoff of 7 days
for analyzing the prognosis of ISSNHL and found a differ-
ence in hearing outcomes between the early and late groups
(Ceylan et al., 2007; Čvorović, Đeric, Probst, & Hegemann,
2008). The cutoff of 7 days in our study was based on these
previous articles. Presence of vertigo is a strongly negative
prognostic factor in ISSNHL. The odds ratio of the proba-
bility of hearing recovery has been reported to be 0.14–
0.20 in ISSNHL patients with vertigo versus those without
(Harada & Kato, 2005; Lee & Ban, 2010; Wang, Huang,
Kuo, & Cheng, 2009).
Although very few previous papers have documented,
our study demonstrated the efficacy of intratympanic ste-
roid on ISSNHL in relation to patients’ age, period from
onset to treatment, and association with vertigo/dizziness.
In this respect, the present results would be a helpful guide
to determine the indication of this therapy for ISSNHL.
On the other hand, this study has some limitations:
Our study is not randomized but historical-controlled, and
the evidence level is 2b. A randomized controlled study
(Evidence Level 1b) remains to be conducted to confirm
the validity of the present results.
Conclusions
We retrospectively analyzed the efficacy of systemic
plus intratympanic steroid in comparison with systemic
steroid plus HBO for ISSNHL in cases with negative prog-
nostic factors. We showed that the former treatment yielded
better hearing outcomes than the latter in old patients,
patients with early treatment, patients with profound hear-
ing loss, and patients associated with vertigo/dizziness,
whereas, in the other patients, the efficacies of the two
treatments were not significantly different. These results
strongly support that systemic plus intratympanic steroid
administration can be a powerful tool for treating ISSNHL,
particularly in cases with negative prognostic factors, such
as old age, profound hearing loss, and/or presence of

6 American Journal of Audiology • 1–7

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vertigo/dizziness. On the basis of these results, audiologists
as well as otolaryngologists would be able to determine an
appropriate indication of intratympanic steroid administra-
tion for ISSNHL and counsel receiving this therapy.
Ethical Approval
All procedures performed in this study were in accor-
dance with the ethical standards of the institutional research
committee and the Helsinki declaration.
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