Hearing results after stapedotomy
for otosclerosis: comparison of
cambridge.org/jlo
Main Article
Dr H Odat takes responsibility for the integrity
of the content of the paper
Cite this article: Odat H, Kanaan Y, Alali M,
Al-Qudah M. Hearing results after stapedotomy
for otosclerosis: comparison of prosthesis
variables. J Laryngol Otol 2021;135:28–32.
https://doi.org/10.1017/S0022215120002595
Accepted: 30 August 2020
First published online: 22 January 2021
Key words:
Otosclerosis; Stapes Surgery; Hearing;
Audiometry
Author for correspondence:
Dr Haitham Odat, Division of Otolaryngology,
Department of Special Surgery,
Jordan University of Science and Technology,
King Abdullah University Hospital,
PO Box 3030, Irbid, Jordan
E-mail: dr.haithamodat@gmail.com
Fax: +962 2709 5123 96
© JLO (1984) Limited, 2021
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prosthesis variables
H Odat , Y Kanaan, M Alali and M Al-Qudah
Division of Otolaryngology, Department of Special Surgery, Jordan University of Science and Technology,
King Abdullah University Hospital, Irbid, Jordan
Abstract
Objective. To evaluate the influence of different piston variables on hearing following
stapedotomy.
Methods. Data were analysed in groups according to: piston material (titanium vs fluoroplas-
tic), shaft diameter (0.4 mm vs 0.5 mm) and crimping style (manual crimping vs self-crimp-
ing). Pre- and post-operative average air–bone gap, air–bone gap difference, success rate and
operative time were evaluated.
Results and conclusion. Fifty-one patients (58 ears) were included. A post-operative air–bone gap
of 10 dB or lower was achieved in 44 cases, with a success rate of 75.9 per cent; 52 cases (89.7 per
cent) had an air–bone gap of 20 dB or lower. The success rate was higher, but not significantly, in
fluoroplastic than in titanium pistons (85 per cent vs 70 per cent). Pistons with shaft diameters of
0.5 mm and 0.4 mm had success rates of 79 per cent and 72 per cent, respectively. No significant
differences were found for any audiometric parameters. There were no significant differences
between manual crimping and self-crimping pistons in terms of audiometric results or success rate.
Introduction
Otosclerosis is characterised by abnormal bone growth in the otic capsule of the temporal
bone. In 70–80 per cent of cases, the disease occurs bilaterally, with a higher female preva-
lence (female: male = 1:2).1,2 The most common location of involvement of otosclerosis is
the bone just anterior to the oval window at a small cleft known as the fissula ante fenes-
tram, which affects about 90 per cent of cases and causes conductive hearing loss associated
with stapes fixation. Less frequently, otosclerosis may cause sensorineural hearing loss
(SNHL) or mixed hearing loss depending on the extent and progression of the disease.2,3
Otosclerosis is one of the most common causes of adult-onset conductive hearing loss.
It has a prevalence of 0.3–0.4 per cent in Caucasians, with a lower prevalence in blacks,
Asians and Native Americans.4,5 Hearing aids and surgical treatment are the most com-
mon current treatment options for otosclerosis. Stapes surgery is a safe procedure, with
excellent hearing outcomes and a low rate of complications, including a less than 1 per
cent risk of post-operative SNHL, vertigo, tinnitus or failure to close the air–bone gap.6
Three techniques of stapes surgery have evolved: total stapedectomy, partial stapedect-
omy and stapedotomy.7 In the latter, most recent technique, a small footplate hole is cre-
ated to allow the insertion of a piston prosthesis. In experienced hands, the three
techniques have been reported to achieve similar clinical outcomes.8 However, many
authors believe that small fenestra stapedotomy is less traumatic to the inner ear, is asso-
ciated with a lower incidence of post-operative SNHL, is associated with fewer vestibular
complications such as perilymph fistula and prolonged vertigo, and results in better high-
frequency hearing improvement compared with stapedectomy.9,10
A stapedotomy fenestration of the oval window can be created using a microdrill, a
laser or Fisch micro-perforators, with no significant differences in the surgical outcome
or complication rate.11,12
A large number of stapes prostheses (pistons), with different shapes (loop and shaft),
sizes, materials (titanium, fluoroplastic, platinum, stainless steel and nitinol), shaft diameters
(range, 0.3–0.8 mm) and crimping styles (manually crimping, heat crimping and self-
crimping), have been developed in order to increase the hearing outcome success rates
and decrease post-operative complications, with variable results reported in the literature.13
This study aimed to evaluate the influence of different piston variables (materials, shaft
diameter and crimping method) on hearing following stapedotomy performed for otosclerosis.
Materials and methods
After obtaining institutional review board approval from our university hospital, the med-
ical records of consecutive adult patients with otosclerosis who underwent stapedotomy
were retrospectively reviewed.
 The Journal of Laryngology & Otology
All patients had progressive conductive hearing loss with an
intact tympanic membrane, and no history of previous
middle-ear surgery or head trauma. Some patients had a posi-
tive family history of hearing loss. Otosclerosis was clinically
suspected and later confirmed by surgical exploration.
All stapedotomies were performed by the same surgeon.
Patients were operated under general anaesthesia, and the
endaural approach was used in all cases. After elevation of
the tympanomeatal flap, curettage of the scutum and separ-
ation of the incudostapedial joint, stapedial fixation was con-
firmed by gentle palpation of the ossicular chain. The
stapedial tendon was cut, and the posterior crus of the fixed
stapes was drilled with a Skeeter® drill system using a 0.6
mm crura saw; this was followed by downfracture of the anter-
ior crus using a right-angled needle. The distance between the
long process of the incus and the footplate was measured, with
the addition of 0.5 mm. Small fenestra stapedotomy was per-
formed by the skeeter drill using a 0.6 mm diamond burr.
Then, the piston was inserted and anchored around the long
process of the incus. According to the type of prosthesis, the
loop was manually crimped or self-crimped around the
incus. No soft tissue grafts were used to seal the oval window.
Prophylactic antibiotic and 16 mg dexamethasone were
given during surgery in all cases. Patients were discharged
home on the day after surgery on oral antibiotics and anal-
gesia, which were taken for one week.
The pistons used were a titanium K-Piston (manual crimp-
ing loop) and a titanium soft-clip piston (self-crimping) (Heinz
Kurz Medizintechnik, Dusslingen, Germany), and a fluoroplas-
tic (self-crimping) piston (Grace Medical, Memphis, Tennessee,
USA).
The data were analysed in groups according to the piston
material (titanium vs fluoroplastic), shaft diameter (0.4 mm
vs 0.5 mm) and crimping style (manual crimping vs self-
crimping). Pre- and post-operative air–bone gaps, air–bone
gap difference, success rate, and operative time were evaluated
for all groups.
Audiometric data were collected after a minimum of one
year of follow up. Pre- and post-operative air–bone gaps
were calculated by subtracting the bone conduction threshold
from the air conduction threshold at frequencies of 0.5, 1, 2
and 3 kHz. The air–bone gap difference was calculated by sub-
tracting the post-operative air–bone gap from the pre-
operative air–bone gap.
A post-operative air–bone gap of 10 dB or less was consid-
ered to indicate successful surgery. Post-operative SNHL was
defined as a mean bone conduction deterioration exceeding
10 dB at the frequencies 1, 2 and 4 kHz, while overclosure
referred to an apparent improvement in bone conduction
hearing due to the Carhart phenomenon at the same frequen-
cies, according to the American Academy of Otolaryngology –
Head and Neck Surgery guidelines.14
We excluded paediatric patients, patients with follow up of
less than one year, those who had undergone previous
middle-ear surgical procedures, and revision cases.
The Mann–Whitney U test was used for non-parametric
data analysis. For categorical data analysis, the chi-square
test or Fisher’s exact test was used, as appropriate. A p-value
of less than 0.05 was considered statistically significant.
Results
Fifty-one patients (58 ears) who underwent stapedotomy for
otosclerosis, and who fulfilled our inclusion and exclusion
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29
Table 1. Patients’ demographic features and clinical characteristics
Characteristic Value
Age (mean ± SD; years) 36.4 ± 10.8
Gender (male: female (n)) 27:31
Operated side (right: left (n)) 31:27
Post-op ABG ≤10 dB (n (%)) 44 (75.9)
Post-op ABG ≤20 dB (n (%)) 52 (89.7)
Post-op SNHL (n (%)) 2 (3)
Operative time (mean ± SD; minutes) 48 ± 8
Pre-op ABG (mean ± SD; dB) 27.7 ± 7.2
Post-op ABG (mean ± SD; dB) 7.5 ± 9.9
ABG difference (mean ± SD; dB) 20 ± 11.3
Overclosure (mean ± SD; dB) 6.4 ± 4
SD = standard deviation; post-op = post-operative; ABG = air–bone gap; SNHL = sensorineural
hearing loss; pre-op = pre-operative
criteria, were included in this study. Their mean age was
36.4 years (range, 18 to 59 years; standard deviation (SD) ±
10.8). Twenty-seven patients (47 per cent) were male and 31
(53 per cent) were female.
Stapedotomy was performed on the right side in 31 ears (53
per cent) and on the left side in 27 ears (47 per cent). The
corda tympani was accidentally cut during surgery in three
cases. The facial nerve was dehiscent in 11 ears; however, the
surgical procedures were completed without difficulties.
Middle-ear adhesions around the stapes were found in nine
cases. Patients were followed up for at least 12 months after
stapedotomy (mean, 35 months; range, 12–60 months).
A post-operative air–bone gap of 10 dB or lower was
achieved in 44 cases, with a success rate of 75.9 per cent; 52
cases (89.7 per cent) had air–bone gap of 20 dB or lower.
The average piston length was 4.4 mm (range, 4–5 mm) and
the average post-operative audiometric improvement was 22
dB (SD ± 8 dB). The mean overclosure was 6.4 dB (range, 1–
14 dB; SD ± 4 dB) (Table 1).
The mean post-operative air–bone gap at 0.5, 1, 2 and 3
kHz was 10, 11, 5 and 7 dB, respectively. Although the air–
bone gap was highest at 1 kHz and lowest at 2 kHz, no statis-
tically significant difference was found between the measured
frequencies ( p > 0.05).
Post-operative SNHL occurred in two cases (3 per cent); in
one case the mean bone conduction deterioration was 14 dB,
and in the other it was 12 dB.
The success rate (air–bone gap of 10 dB or lower) was
higher for cases with fluoroplastic than titanium pistons, but
this difference was not significant (85 per cent vs 70 per
cent, p = 0.12) (Table 2). The success rates for pistons with
shaft diameters of 0.5 mm and 0.4 mm were 79 per cent and
72 per cent, respectively. No significant differences were
found for any audiometric parameters (Table 3).
There were no statistically significant differences between
the manual crimping and self-crimping pistons in regard to
audiometric results, success rate or operative time (Table 4).
Revision stapedotomy was performed for two patients
because of a short prosthesis. Another two patients had an
eroded long process of the incus, for which malleo-stapedotomy
was conducted. None of the patients had prolonged vertigo or
prolonged taste disturbance. Furthermore, delayed healing, tym-
panic membrane perforation and sagging of the scutum were
not seen.
 30 H Odat, Y Kanaan, M Alali et al.

Table 2. Comparison between titanium and fluoroplastic pistons Table 4. Comparison between piston crimping methods
†
Parameter Titanium* Fluoroplastic P-value Manual
Parameter crimping* Self-crimping† P-value
Pre-op ABG 27 ± 7 29 ± 7 0.37
(mean ± SD; dB) Pre-op ABG 28 ± 7 28 ± 7 0.37
(mean ± SD; dB)
Post-op ABG 10 ± 12 6±7 0.12
(mean ± SD; dB) Post-op ABG 10 ± 12 6±7 0.12
(mean ± SD; dB)
ABG difference 17 ± 12 23 ± 9 0.05
(mean ± SD; dB) ABG difference 18 ± 12 22 ± 10 0.05
(mean ± SD; dB)
Success rate (%) 70 85 0.12
Success rate (%) 75 76.5 0.9
Operative time 49 ± 8 46 ± 8 0.19
(mean ± SD; minutes) Operative time 48 ± 6 46 ± 8 0.22
†
(mean ± SD; minutes)
*n = 31; n = 27. Pre-op = pre-operative; ABG = air–bone gap; SD = standard deviation;
post-op = post-operative *n = 24; †n = 34. Pre-op = pre-operative; ABG = air–bone gap; SD = standard deviation;
post-op = post-operative

Table 3. Comparison between piston shaft diameters

Shaft diameter Shaft diameter
Parameter 0.4 mm* 0.5 mm†
Pre-op ABG 27 ± 8 29 ± 7
(mean ± SD; dB)
Post-op ABG 8 ± 10 8 ± 10
(mean ± SD; dB)
ABG difference 19 ± 11 21 ± 11
(mean ± SD; dB)
Success rate (%) 72 78.8
†
*n = 25; n = 33. Pre-op = pre-operative; ABG = air–bone gap; SD = standard deviation;
post-op = post-operative
Discussion
Otosclerosis is a common ear disease all over the world; 10 per
cent of all hearing loss and 18–22 per cent of adult conductive
hearing loss is caused by this disease.2,5 Nowadays, stapedot-
omy is considered the most commonly performed surgical
procedure to correct the conductive hearing loss caused by
otosclerosis. It is a highly successful surgery, with success
rates ranging between 70 per cent and 95 per cent, and with
a low rate of complications.6,15
Many surgeons have focused on the prosthesis (piston) as
an important factor in the post-operative outcomes. They
have studied the effect of different prosthesis materials, shaft
diameters and crimping styles. However, there is no clear evi-
dence that one prosthesis design achieves significantly better
post-operative hearing outcomes than another.13,16,17
In this study, fortunately, we were able to analyse different
stapes piston variables using similar sample sizes. All patients
were operated on with the same technique by the same sur-
geon. Our results showed that higher success rates (but not sig-
nificantly higher) were achieved in cases where fluoroplastic
pistons, pistons with a shaft diameter of 0.5 mm and self-
crimping pistons were used, compared with titanium pistons,
pistons with a shaft diameter of 0.4 mm and manual crimping
pistons, respectively ( p > 0.12).
Massey et al.18 compared the post-operative hearing results
of 218 patients who underwent stapedotomy; 35 patients
received titanium prostheses and 183 received Teflon pros-
theses. Surgical success was achieved in 86 per cent of the
Teflon group compared with 71 per cent of the titanium
group, with no significant difference. The overall rate of
SNHL was 2.8 per cent (1.6 per cent in the Teflon group vs
8.6 per cent in the titanium group). This difference was not
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statistically significant and may have been caused by manipu-
P-value lation of the stapes suprastructure or footplate, rather than the
0.3
prosthesis itself.
Casale et al.19 compared the hearing results obtained after
primary stapedotomy involving the implantation of 30 fluoro-
0.92
plastic pistons with a shaft diameter of 0.6 mm and 30 titan-
ium pistons with a shaft diameter of 0.4 mm. They found
0.57
statistically significant bone conduction improvements at 1
kHz and 2 kHz in favour of the fluoroplastic group.
0.55
There is inconsistent evidence for the effect of piston shaft
diameter in primary stapedotomy on hearing outcomes for
otosclerosis patients. Theoretically, the best hearing results
could be achieved by using a larger shaft diameter, because
it will transmit more sound energy into the vestibule because
of the larger surface area of contact.20 In contrast,
Hüttenbrink21 suggested that the small surface area of contact
for smaller pistons (minimum of 0.4 mm) is compensated by a
much larger vibration amplitude. Casale et al.19 suggest that an
increase in shaft diameter results in greater hearing improve-
ment at the low-frequency threshold, while a decrease in diam-
eter results in greater improvement at high frequencies.
However, in practice this issue remains controversial, and
inconsistent acoustic results with different piston diameters
have been reported.
A systematic review of the effect of piston diameter in
stapes surgery revealed that approximately 50 per cent of the
included studies showed no significant difference in hearing
outcomes regarding the shaft diameter, while the other 50
per cent showed a significantly better hearing outcome asso-
ciated with the use of pistons with a larger shaft diameter
rather than a smaller one. None of the studies showed a differ-
ence in SNHL incidence.22
Gristwood and Venables23 compared the hearing results
following stapedotomy using pistons with a 0.6 mm shaft
diameter (332 cases) versus a 0.8 mm diameter (52 cases).
They found that shaft diameter had little effect on the out-
come, except at 6 kHz and 8 kHz, where the 0.6 mm piston
appeared to have a significant advantage. Furthermore,
Sennarog lu et al.24 reported statistically significant differences
in hearing outcomes at 0.5, 1 and 2 kHz for the 0.8 mm diam-
eter piston group compared with the 0.6 mm group. In a
meta-analysis and systematic review, Laske et al.16 found that
a 0.6 mm diameter prosthesis was associated with significantly
better results than a 0.4 mm prosthesis.
A temporal bone model showed a modest effect of piston
diameter on hearing results following stapedotomy using 0.4
 The Journal of Laryngology & Otology
mm, 0.6 mm and 0.8 mm pistons.20 Marchese and colleagues13
compared 112 cases of stapedotomy using a 0.6 mm piston
diameter with 100 cases using 0.4 mm pistons. They found
that an increase in piston diameter gave better results, espe-
cially at low frequencies. In contrast, others reported statistic-
ally insignificant differences in hearing results between 0.4 mm
and 0.6 mm pistons.25,26
A review of the limited literature revealed that Hornung
et al.27 compared pistons of 0.4 mm diameter (nitinol-
polytetrafluoroethylene) in 18 cases with those of 0.5 mm
diameter (‘SMart’ pistons) in 21 cases, with a follow-up time
of 12 months or more. In that study, the mean post-operative
air–bone gap was 4.4 dB (SD ± 3.1) in the 0.4 mm group versus
5.7 dB (SD ± 5.0) in the 0.5 mm group. with success rates of 94
per cent and 90 per cent, respectively, which were statistically
insignificant. We found the same insignificant differences in
our study for both the mean post-operative air–bone gap
and the surgical success rate ( p > 0.3).
In general, a smaller diameter prosthesis is the preferred
choice when the facial nerve is prominent or the oval window
is particularly narrow. Otherwise, an experienced surgeon
should be able to achieve good hearing results with whichever
prosthesis is used.17,26
Good prosthesis fixation keeps the piston in place and
secures long-time hearing improvement. Very loose or very
tight crimping may cause incus erosion. Hence, manual
crimping requires the surgeon to have a good feeling of the
appropriate applied force; otherwise, incus dislocation or
inner-ear damage may occur.28 A self-crimping piston does
not fully encircle or apply tight pressure on the incus, theoret-
ically reducing the risk of strangulation.17
Wegner et al.29 conducted a systematic review on the effect
of different crimping techniques in stapes surgery. They found
that seven studies comparing manual crimping with self-
crimping pistons showed no significant difference, or showed
a difference in favour of manual crimping. However, statistical
significance was reached in three studies, with mean differ-
ences of 22.7–26.0 dB, in favour of no crimping. None of the
crimping methods seemed to result in increased
complications.
Tange and Grolman30 retrospectively analysed the air–bone
gap closure obtained using a crimping and a non-crimping
titanium prosthesis. They reviewed 126 cases; 63 patients
received a titanium K-Piston prosthesis and 63 patients
received a titanium CliP® piston. The overall results of both
pistons were good, but there was no statistically significant dif-
ference between the two prostheses in terms of the success rate
( p = 0.57).30 Schrötzlmair et al.31 compared 28 titanium pis-
tons (manual crimping) with 13 clip pistons (self-crimping).
They found a statistically significant difference in favour of
clip pistons. In our study, no significant difference was
found between these methods of crimping.
We believe that the variable results reported by different
authors might be explained by study design, sample size, selec-
tion bias, differences in reporting audiometric results, and dif-
ferences in surgical experience. In our opinion, the latter is the
main factor influencing the post-operative outcomes, rather
than the prosthesis specifications. We were able to achieve
favourable results with low complication rates with whichever
prosthesis was used. However, further prospective, double-
blind, randomised, controlled clinical trials, conducted on a
larger number of patients and with long-term follow-up
time, may be necessary to prove whether different piston
designs do have an impact on post-operative air–bone gap
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31
and success rate, and affect the risk of complications such as
incus necrosis or SNHL.
Most previous studies investigating the effects of the piston
on the outcome of stapes surgery have compared the effect of
one prosthesis specification with another. Mangham32 was the
only person to report the comparison of three piston variables,
using either a titanium 0.6 mm CliP piston, or a platinum-
ribbon Teflon 0.5 mm or a 0.6 mm piston. The author found
that the Teflon piston produced better hearing results than
the titanium piston; the superior results of Teflon were
explained as being due to the larger actual shaft diameter. In
addition, the mean air–bone gap for the Teflon 0.6 mm piston
(5.1 dB) was significantly smaller than that for the titanium
0.6 mm piston (8.1 dB) and the Teflon 0.5 mm piston (7.5
dB); however, the success rates did not differ.
The limitations of this study include its retrospective design
and the relatively small number of patients. However, its find-
ings are of great value given that it is only the second study in
the literature to report the influence of the three prosthesis
variables (material, shaft diameter and crimping) in stapes sur-
gery performed for otosclerosis.27 In addition, it is only the
second study to compare 0.4 mm shaft diameter pistons with
0.5 mm diameter pistons.32
• Stapedotomy is the most popular surgical treatment for otosclerosis
• The influence of piston specifications on hearing following stapedotomy
remains controversial
• The impact of piston variables (materials, shaft diameter and crimping
method) on hearing following stapedotomy for otosclerosis was
evaluated
• Piston material, shaft diameter and crimping method had no statistically
significant effect on stapedotomy success rate
• Surgical experience is likely to be the main factor contributing to the best
outcome and low complication rate
Our results show that piston material, shaft diameter and
crimping method have no statistically significant effects on
the success rate of stapedotomy. High-quality studies with a
larger sample size and long-term follow up may be necessary
to confirm these findings. We believe that surgical experience
is the main factor needed to achieve the best outcome with low
complication rates.
Competing interests. None declared
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