International Journal of Pediatric Otorhinolaryngology 118 (2019) 97–102

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International Journal of Pediatric Otorhinolaryngology

journal homepage: www.elsevier.com/locate/ijporl

The Bonebridge implant in older children and adolescents with mixed or T

conductive hearing loss: Audiological outcomes
Anna Ratuszniaka,∗, Piotr Henryk Skarzynskib,c,d, Elzbieta Gosd, Henryk Skarzynskia
a
Institute of Physiology and Pathology of Hearing, World Hearing Center, Otorhinolaryngology Surgery Clinic, Mokra 17 Str., 05-830, Kajetany, Poland
b
Institute of Sensory Organs, Kajetany, Mokra 1 Str., 05-830, Kajetany, Poland
c
Heart Failure and Cardiac Rehabilitation Department, Second Faculty, Medical University of Warsaw, Banacha 1a, 02-097, Warsaw, Poland
d
Institute of Physiology and Pathology of Hearing, World Hearing Center, Teleaudiology Department, Mokra 17 Str., 05-830, Kajetany, Poland

A R T I C LE I N FO A B S T R A C T

Keywords: Introduction: For children with conductive or mixed hearing loss, in whom use of conventional hearing aids is
Conductive hearing loss impossible or limited, use of bone conduction devices is recommended. The choice between the available types
Mixed hearing loss of devices depends mostly on the degree of hearing loss, age, and anatomical conditions. One device application
Bonebridge in children older than 5 years is the Bonebridge implant. The aim of this study is to assess the benefits and safety
Hearing implant
of this device in children.
Bone conduction
Methods: The material was a group of 11 older children and adolescents aged 10–17 years (mean = 14.7,
SD = 2.45) with single-sided or bilateral conductive or mixed hearing loss, implanted unilaterally with the
Bonebridge system at the World Hearing Center in Kajetany near Warsaw between 2014 and 2016. Benefits of
the Bonebridge were assessed with warble tone audiometry and word audiometry in free field, as well as an
APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire before and after implantation.
Results: Hearing tests showed a statistically significant improvement in hearing sensitivity and speech dis-
crimination. Results of the questionnaire confirm the benefits of Bonebridge implantation to the older children in
terms of their auditory performance under various acoustic conditions.
Conclusions: At a one-year follow up the Bonebridge system was found to be a safe, efficient, and effective tool
for compensating for conductive or mixed hearing loss in older children and adolescents. For good anatomical
conditions the Bonebridge implant provides a safe alternative to other popular bone conduction systems.

1. Introduction ear implants [4]. If there is no possibility of applying air conduction

The chief causes of conductive and mixed hearing losses are con-
genital malformations of the outer and/or middle ear (including mi-
crotia with atresia, 1 in 10000 births [1]), isolated atresia of the ex-
ternal ear canal, middle ear malformations, and acquired defects (most
often due to chronic otitis in the external and middle ear). Depending
on the etiology of hearing loss, the options for improving hearing are
pharmacological or surgical treatment, or provision of a hearing pros-
thesis. The sort of intervention depends on the type and degree of
hearing loss, configuration of binaural hearing, age of the child, coex-
isting pathologies, anatomical conditions, previous surgical interven-
tions, and broadly defined environmental conditions [2,3]. The range of
devices that can compensate for conductive or mixed hearing loss en-
compasses air or bone conduction hearing aids, various types of par-
tially implantable solutions using bone conducted sounds, and middle
hearing aids, or there is some limitation in this regard, auditory inter-
vention in children starts with bone conduction devices fixed to a
softband or adhesive adapter [5]. This type of intervention does not
require surgery and can be applied relatively fast following audiological
diagnosis of the infant. However, pressure of the vibrating transducer
on softband causes discomfort in extended use, and skin and soft tissue
between the transducer and bone limit the amount of energy that can be
effectively transmitted. As a result, the literature has noted cases where
these devices have been rejected by the child [6,7].
Clinical application of Bone Anchored Hearing Aids (BAHA) started
in the late 1970s and has ways of overcoming these limitations, parti-
cularly (since 1983) in children [8]. Since 1999, the FDA in the USA has
allowed the use of temporal bone anchored devices in children older
than 5 years. In Europe, the minimum age of application of this type of
device is not regulated by law, although based on clinical experience

∗
Corresponding author. Institute of Physiology and Pathology of Hearing, World Hearing Center, Mokra 17 Str., 05-830, Kajetany, Poland.
E-mail address: a.ratuszniak@ifps.org.pl (A. Ratuszniak).

https://doi.org/10.1016/j.ijporl.2018.12.026
Received 24 July 2018; Received in revised form 17 December 2018; Accepted 19 December 2018
Available online 21 December 2018
0165-5876/ © 2018 Elsevier B.V. All rights reserved.
A. Ratuszniak et al.
many centers recommend application only beyond 3 years of age. This
limitation relates to the thickness of the skull and the risk of implant
extrusion. Particular caution needs to be observed in children with
genetic defects, in whom the bone of the skull may develop more
slowly. Over time, BAHA devices have turned out to be a highly suc-
cessful approach in patients with conductive or mixed hearing loss,
including children. The authors of numerous publications point to the
high effectiveness of these devices in terms of hearing benefits. Pub-
lications also include reports of complications, mostly due to implant
displacement and dermatological conditions. The loss of an implant due
to incorrect osseointegration in a child is reported at about 0–15%, with
strong negative correlation to the child's age at implantation [9–11].
In 2012, the Bonebridge active bone conduction implant (Med-El,
Innsbruck, Austria) was introduced into clinical practice, and in 2014 it
was allowed for use in children older than 5 years [3]. A primary
audiological criterion for its use in cases of conductive or mixed hearing
loss is single-sided or bilateral hearing loss with bone conduction
thresholds not higher than 45 dB HL at 500, 1000, 2000 and 3000 Hz.
The system does not penetrate the skin and is made up of an internal
part with a vibrating electromagnetic transducer (BC-FMT - Bone Con-
duction Floating Mass Transducer) and an external part (the sound pro-
cessor). The acoustic signal from the environment is transformed into
mechanical vibrations that are transmitted to bone in the mastoid area.
Electromagnetic transmission between the internal and external part
reduces risks related to skin penetration while preserving good signal
quality; its technical capabilities allow a maximum output strength at a
level comparable to those obtained with BAHA devices (Cochlear,
Sydney, Australia) [12]. In the context of using these devices in chil-
dren, it should be noted that the cylinder-shaped vibrating transducer
(the BC-FMT) is rather large, with a diameter of 15.8 mm and height of
8.7 mm. For this reason its safe implantation depends strongly on
anatomical conditions, and so a preoperative CT examination is re-
commended, especially in children [13,14].
Implantation options can be expanded by using spacers (pad
thickness of 1–4 mm) under the poles of the implant. More than 5 years'
experience with the Bonebridge implant in various clinical centers
provide abundant reports and document significant auditory benefits in
terms of improvement of hearing sensitivity, speech discrimination and
quality of life [13,15–19]. Reports on the effectiveness of the Bone-
bridge in children list improvements in hearing sensitivity and speech
discrimination (in silence and in noise), as well as better sound source
localization [17,20–27].
The aim of this study is to assess the safety and benefits of the
Bonebridge implant in older children and adolescents with conductive
or mixed hearing loss.
2. Material and method
2.1. Patients
Retrospective analysis of data obtained during routine clinical
practice was done with the consent of the local bioethics committee
(approval no. IFPS/KB/11/2016). Analysis involved examining the data
of 11 pediatric patients implanted unilaterally with the Bonebridge
implant at the World Hearing Center (Kajetany/Warsaw, Poland) be-
tween 2014 and 2016. Patients had been qualified for surgery based on
the clinical procedures commonly used in this center. The mean age in
the study group was 14.7 years (range 10–17 years, SD 2.45). They
were 2 girls and 9 boys diagnosed with conductive hearing loss (n = 5)
or mixed hearing loss (n = 6) in the ear selected for implantation. In 10
cases hearing loss was caused by a congenital defect of the external
and/or middle ear. In three cases patients with bilateral hearing loss
used air conduction hearing aids, in other cases they did not have any
experience in a long-term use of a hearing prosthesis. Demographic data
of the study group are presented in Table 1. In total, the Bonebridge
implant was provided to 12 children in Poland in 2014–16: one in a
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International Journal of Pediatric Otorhinolaryngology 118 (2019) 97–102
case of single-sided deafness and 11 in cases of conductive or mixed
hearing loss, the latter being the subject of this analysis.
2.2. Surgical approaches and device fitting
Because of the age of the patients, size of the BC-FMT transducer,
and risk of marginal anatomical conditions for Bonebridge implanta-
tion, in each case a CT examination was performed in order to evaluate
how best to position the BC-FMT in the mastoid bone. In all patients
surgery was conducted under general anesthesia following standard
procedures suggested by the manufacturer of the device. Following CT
analysis, in all cases the Bonebridge implant was placed anteriorly to
the sinodural angle, in the space delineated posteriorly by the sigmoid
sinus, superiorly by the dura in the middle cranial fossa, and anteriorly
by the posterior wall of the external auditory canal. In one case (ID9) it
was necessary to apply a spacer 2 mm under the inferior pole of the
implant. The postoperative period was uneventful in all cases. The
sound processor was activated 4–6 weeks after implantation. During the
fitting in-situ measures in the individual patients were performed using
the Vibrogram available in the device producer's software.
2.3. Audiometric tests
Assessment of the safety and benefits of the Bonebridge implant was
done based on the following tests:
1. Pure tone audiometry performed with an Otometrics Madsen Itera II
audiometer, with measurements made before and after implanta-
tion; air conduction was measured in on-ear headphones for
125–8000 Hz; bone conduction was measured using a calibrated
bone transducer for 250–4000 Hz. Measurements were performed in
a soundproof audiometric chamber.
2. Free-field audiometry was performed in an adapted, soundproofed
room with the signal presented from a loudspeaker placed at the
height of the subject's ears at a distance of 1 m and angle of 0°.
Hearing thresholds were determined using warble tones over the
range 500–4000 Hz at octave intervals. Based on the data we cal-
culated functional gain (FG) for 500, 1000, 2000 and 4000 Hz and
mean functional gain.
FG(f) = HTL FF(f) unaided – HTL FF(f) aided [dB],
where HTL FF is the hearing threshold in free-field.
3. Word audiometry in free-field was performed under the same con-
ditions as threshold audiometry; measurements were performed in
silence with speech signal levels of 50, 60, and 70 dB SPL using
monosyllabic words from the list of Polish word compiled by
Demenko and Pruszewicz; word recognition score (WRS) [%] was
calculated. Free-field tests were performed in unaided and aided
conditions at 1 and 12 months after activation.
The contralateral ear was always double blocked: plugged with
deeply inserted foam earplugs (3M Earplugs 1100, SNR = 37 dB) and
covered with ear muffs (3M Peltor X5, SNR = 37 dB).
2.4. Patient questionnaire
Assessment of benefits from the implant was done based on the
APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire at
6–12 months after implantation and was compared to scores obtained
before implantation. APHAB is a self-assessment questionnaire com-
prising 24 questions about the scale of the problems in auditory func-
tioning grouped in 4 categories: EC (Ease of Communication); BN
(Background Noise); RV (Reverberation); and AV (Aversiveness) [28].
A. Ratuszniak et al. International Journal of Pediatric Otorhinolaryngology 118 (2019) 97–102

Table 1
Patient demographics, etiology and otologic history, surgical approaches.
ID Sex Age at surgery Hearing loss Implanted side BC-FMT BCI lifts Etiology
(years) position
Right Left

1 F 17,0 MHL MHL R SDA None Congenital malformation, fibrous dysplasia of the skull bones
2 F 16,0 NH MHL L SDA None Microtia and atresia – left ear
3 M 14,0 MHL NH R SDA None Microtia and atresia – right ear
4 M 17,0 MHL NH R SDA None Microtia and atresia – right ear
5 M 17,0 CHL NH R SDA None Microtia and atresia, congenital malformation in middle right ear
6 M 16,0 MHL MHL L SDA None Congenital malformation in outer and middle ear
7 M 11,0 CHL CHL L SDA None Congenital malformation in outer and middle left ear. Cleft of soft
palate and transverse facial cleft; chronic otitis media – right ear
8 M 12,0 NH MHL L SDA None Acquired stenosis of the external auditory canal in left ear
9 M 16,0 CHL NH R SDA 2 mm lift under the inferior Congenital malformation in outer and middle right ear, microtia
pole of the transducer and atresia
10 M 16,0 CHL NH R SDA None Congenital malformation in outer and middle right ear
11 M 10 CHL NH R SDA None Atresia – right ear

F, female; M, male; CHL, conductive hearing loss; MHL, mixed hearing loss; NH, normal hearing; R, right; L, left; BCI lifts, Bone Conduction Implant lifts; SDA,
sinodural angle.

The overall score is the mean score of the first three categories. lowest for 500 Hz. The mean functional gain after 1 month was 28 dB;
after 12 months it was 30 dB (Fig. 2). Mean thresholds obtained in free
field under unaided and aided conditions after 1 and 12 months from
3. Results
system activation are presented in Table 3. Differences between the
time intervals are not statistically significant and indicate stability of
The assumption of normal distribution of the variables was tested
results over time.
with the Shapiro–Wilk test. Then, in the case of variables with a normal
Mean unaided word recognition scores obtained using free field
distribution a paired t-test was used to compare the outcomes before
word audiometry 12 months after system activation were 1.25, 8.13,
and after Bonebridge implantation. In cases lacing a Gaussian dis-
and 26.88% for signals presented at 50, 60, and 70 dB SPL respectively;
tribution the Wilcoxon test was used. The level of statistical significance
for aided conditions the corresponding figures were 38.13, 68.13, and
was specified as p < 0.05. Statistical analysis was performed using IBM
76.25%. At each level of signal presentation, mean word recognition
SPSS Statistics 24.
scores were significantly higher (p < 0.05) under aided conditions
Effectiveness of the surgical procedure was assessed by comparing
compared to unaided (Fig. 3).
bone conduction thresholds obtained by pure tone audiometry before
Analysis of the APHAB scores obtained before and after implanta-
and after surgery. Mean bone conduction value PTA4 BC before surgery
tion showed a statistically significant improvement on the first three
was 16.82 dB HL (SD = 10.90) and after surgery 16.57 dB HL
subscales, confirming the benefits in everyday functioning. The mean
(SD = 8.70). Table 2 shows that differences in mean values of bone
number of reported problems with hearing in different acoustic con-
conduction thresholds PTA4 BC were not statistically significant
ditions, expressed as Global Score, was 45% before implantation and
(p > 0.05). Fig. 1 shows mean values of bone conduction thresholds
22% after implantation (Fig. 4).
obtained by pure tone audiometry for patients who were tested both
before and after implantation (n = 10).
4. Discussion
The results of free-field audiometry showed a statistically significant
improvement of hearing sensitivity after application of the Bonebridge
Making decisions about any medical intervention requires weighing
system. The highest value of functional gain was for 4000 Hz, the
up the potential benefits against the risks. In terms of partially im-
plantable hearing prostheses, the risks related to surgery are upper-
Table 2
Individual and mean audiological data for the implanted ear measured before most, but the device's usability is also important, and this relates to the
and after Bonebridge implantation. patient's life-style and how they behave in various acoustic, environ-
mental, and social situations. These factors are particularly important in
ID PTA4 AC PTA4 BC ABG PTA4 AC PTA4 BC ABG after
the case of children and adolescents.
[dB HL] [dB HL] before [dB HL] [dB HL]
before before after after Implantation of the Bonebridge involves no skin penetration and no
(n = 11) (n = 11) (n = 10) (n = 10) strong pressure, and therefore there is improved user safety, lesser risk
of complications, and higher user comfort. For these reasons the device
1 83.75 41.25 42.50 85.00 33.75 51.25
is a practical alternative to other systems such as softband or bone
2 77.50 23.75 53.75 NT NT –
3 70.00 23.75 46.25 70.00 20.00 50.00 anchored hearing aids. However, the size of the implantable vibrating
4 66.25 23.75 42.50 68.75 21.25 47.50 transducer appears to considerably limit the number of potential pe-
5 75.00 17.50 57.50 70.00 25.00 45.00 diatric users, despite the device being allowed to be used in children
6 60.00 13.75 46.25 62.50 13.75 48.75 over 5 years of age. Habesoglu at al [29]. have shown that the mastoid
7 67.50 5.00 62.50 76.25 17.50 58.75
8 43.75 13.75 30.00 42.50 12.50 30.00
process may be smaller in children following chronic otitis media or
9 63.75 7.50 56.25 60.00 6.25 53.75 cholesteatoma. Some specialists locate the implant behind the venous
10 60.00 11.25 48.75 73.75 12.50 61.25 sinus directly on the meninges. In the case of people with microtia or
11 53.75 3.75 50.00 50.00 5.00 45.00 atresia, placing the device further back from the ear can be important
MV 65.57 16.82 48.75 65.88 16.75 49.13
for future management, as space is left for potential plastic surgery. On
SD 11.26 10.90 8.89 12.57 8.70 8.62
the other hand, we do not see the need to risk placing the implant di-
AC, air conduction; BC, bone conduction; PTA4, pure tone average (for 500, rectly on the meninges (where the bone of the skull may be excessively
1000, 2000, 4000 Hz); ABG, air-bone gap; MV, mean value; SD, standard de- thin). Therefore, all patients in this work had the devices implanted on
viation; NT, not tested. the temporal bone. According to Rahne et al. [30], the options for

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A. Ratuszniak et al. International Journal of Pediatric Otorhinolaryngology 118 (2019) 97–102

Fig. 1. Bone-conduction thresholds (PTA4 BC) before and after Bonebridge implantation (n = 10); the boxes represent mean scores and standard errors; the whiskers
represent 95% confidence intervals; ns, not significant.

Fig. 2. Functional gain for 4 frequencies and mean value after 1 and 12 months (n = 8); the bars are mean scores; the error bars represent standard deviation; ns, not
significant.

Table 3 old at the time of implantation, and only three children were younger
Mean values of hearing thresholds obtained in free field (n = 8). than 14 years. In all study group the surgical procedure was typical and
After 1 month After 12 months no complications or adverse effects were noted during the in-
traoperative and postoperative period. Only in one child, a 16-year old
Mean PTA4 FF unaided [dB HL] 61.41 (SD = 4.35) 62.5 (SD = 3.72) boy, was it necessary to use a 2 mm thick spacer. Nevertheless the
Mean PTA4 FF aided [dB HL] 31.63 (SD = 7.71) 32.19 (SD = 7.49)
authors recommend always performing a CT before making a decision
about a Bonebridge implant in a child.
In line with other reports [16,17,22] where comparable values of
placing the transducer improve with age, and in children 12–14 years
bone conduction thresholds have been obtained (as shown by pure tone
old it is possible to fully insert the transducer in 50% of cases. Use of
audiometry before and after implantation), Bonebridge implantation
spacing pads (BC-lifts) increases the possibilities to as much as 50% in
can be considered effective. Results of the present study confirm that
children older than 6 years and 100% in children 9 years old and older.
use of the Bonebridge implant in children is safe and effective; our
The population analyzed in this work are older children and ado-
results are similar to those reported in adults in the multicenter analysis
lescents with a mean age of 14.7 years. The youngest child was 10 years
published by Sprinzl et al. [13]. In their systematic review, reported

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A. Ratuszniak et al.
Fig. 3. Word recognition scores under unaided and aided conditions 12 months after Bonebridge activation; bars represent mean scores; error bars represent standard
deviation; *p < 0.05; **p < 0.01.
values of functional gain were in the range of 24–37 dB (based on 7
studies). Kulasegarah et al. [23] report a functional gain of 35.6 dB in a
group of 10 children aged 5–15 years. In the present study the func-
tional gain was 28 and 30 dB after 1 and 12 months of use respectively.
Baumgartner et al. in a group of 12 implanted children aged 5–17 years
report obtaining free-field hearing thresholds of between 25 and 35 dB
HL over a wide range of frequencies [21]; in the present study we have
obtained mean threshold values of between 32 and 33 dB HL. The
highest functional gain in our group was at 4 kHz, similar to the results
reported by Bravo-Torres et al. [20] for a group of 15 children 5–17
years old.
In their systematic review, Sprinzl et al. [13] report a mean word
discrimination score after Bonebridge implantation of 78%, comparable
to the score of 76% obtained in the present study.
In an assessment of the safety and effectiveness of the Bonebridge
system in children, Baumgartner at al [21]. report a short-term im-
provement of word discrimination score from 14.5% to 67.2% (mea-
sured using a 65 dB SPL signal level) 1 month after system switch-on
and then to 82.1% after 3 months. Their analysis was done on a group
of similar size to ours. The results of our study were stable after 1 and
12 months, both in terms of hearing sensitivity and speech under-
standing, similar to other reports [32].
Fig. 4. Results of APHAB questionnaire; the bars represent mean scores; the error bars represent standard deviation; *p < 0.05; **p < 0.01; ***p < 0.001.
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International Journal of Pediatric Otorhinolaryngology 118 (2019) 97–102
Results of the subjective, questionnaire-based assessment of the
Bonebridge system are reported mostly in adults; Ihler et al. and
Bianchin et al. have confirmed its everyday benefits [15,33]. The
findings from our APHAB questionnaire confirm these benefits.
Even though the results of our study, both at 1 month and 12
months, confirm the safety and effectiveness of Bonebridge implanta-
tion in older children, continued observation of its effects is necessary.
Because children undergo rapid age-related cognitive and social de-
velopment, and their environments change depending on favored ac-
tivities, it is essential to keep track of the perceived subjective benefits
and the impact of surgical intervention on quality of life.
Most of the reports in the literature on the results of Bonebridge
implantation in children have employed small study groups, up to 20
patients. This report uses a similar size. In the future all such data might
be brought together as part of a metaanalysis which could draw much
stronger conclusions about the safety, efficacy, and effectiveness of this
solution for children.
5. Conclusions
Over a follow-up period of 1 and 12 months the Bonebridge system
has been seen as a safe tool for compensating for conductive or mixed
A. Ratuszniak et al.
hearing loss in older children and adolescents. The results obtained in
our group of 11 patients showed considerable hearing benefits. With
appropriate anatomical conditions, this solution offers a safe alternative
to other commonly used systems based on bone conduction. However,
long-term follow-up is still needed, both in terms of hearing benefits
and possible complications.
Disclosure statement
Declarations of interest
None.
Funding
This research did not receive any specific grant from funding
agencies in the public, commercial, or not-for-profit sectors.
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