International Journal of Audiology

ISSN: 1499-2027 (Print) 1708-8186 (Online) Journal homepage: http://www.tandfonline.com/loi/iija20

Active transcutaneous bone conduction implant:

audiological results in paediatric patients with
bilateral microtia associated with external
auditory canal atresia

Sofía Bravo-Torres, Carolina Der-Mussa & Eduardo Fuentes-López

To cite this article: Sofía Bravo-Torres, Carolina Der-Mussa & Eduardo Fuentes-López (2017):
Active transcutaneous bone conduction implant: audiological results in paediatric patients with
bilateral microtia associated with external auditory canal atresia, International Journal of Audiology,
DOI: 10.1080/14992027.2017.1370137

To link to this article: http://dx.doi.org/10.1080/14992027.2017.1370137

Published online: 31 Aug 2017.

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 International Journal of Audiology 2017; Early Online: 1–8

Original Article

Active transcutaneous bone conduction implant: audiological

results in paediatric patients with bilateral microtia associated
with external auditory canal atresia
Downloaded by [University of Connecticut] at 01:54 01 September 2017

Sofı́a Bravo-Torres1,2, Carolina Der-Mussa1,3, and Eduardo Fuentes-López4,5

1
Unidad de Otorrinolaringologia, Servicio de Cirugia, Hospital Dr. Luis Calvo Mackenna, Santiago, Chile, 2Carrera de Fonoaudiologia,
Facultad de Ciencias de la Rehabilitacion, Universidad Andres Bello, Santiago, Chile, 3Clinica Alemana de Santiago, Facultad de Medicina
Universidad del Desarrollo, Santiago, Chile, 4Programa de Doctorado en Salud Pública, Escuela de Salud Pública, Universidad de Chile,
Santiago, Chile, and 5Carrera de Fonoaudiologı́a, Departamento de Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad
Católica de Chile, Santiago, Chile

Abstract
Objective: To describe, in terms of functional gain and word recognition, the audiological results of patients under 18 years of age
implanted with the active bone conduction implant, BonebridgeÔ. Design: Retrospective case studies conducted by reviewing the medical
records of patients receiving implants between 2014 and 2016 in the public health sector in Chile. Study sample: All patients implanted with
the Bonebridge were included (N ¼ 15). Individuals who had bilateral conductive hearing loss, secondary to external ear malformations,
were considered as candidates. Results: The average hearing threshold one month after switch on was 25.2 dB (95%CI 23.5–26.9). Hearing
thresholds between 0.5 and 4 kHz were better when compared with bone conduction hearing aids. Best performance was observed at 4 kHz,
where improvements to hearing were observed throughout the adaptation process. There was evidence of a significant increase in the
recognition of monosyllables. Conclusions: The Bonebridge implant showed improvements to hearing thresholds and word recognition in
paediatric patients with congenital conductive hearing loss.

Key Words: Implantable hearing aids, paediatrics, speech perception, behavioural measures, hearing
aids, pathology

Introduction
Atresia of the external auditory canal affects one in every 10,000–
20,000 live births. It is mostly present unilaterally (only 30% is
bilateral), in men and in the right ear (Jafek et al. 1975; Kelley and
Scholes 2007; El-Begermy et al. 2009); and can be associated with
microtia (Lo et al. 2014). A large percentage occurs in isolation,
while associated forms often have genetic causes as part of
craniofacial disorders (Nazer, Lay-Son, and Cifuentes 2006).
Varying degrees of conductive hearing loss are present in
80–90% of patients (Siegert, Matthies, and Kasis 2007).
An aesthetic and functional approach can be adopted in treating
patients with atresia and microtia. Reconstructive surgery with
autologous cartilage has shown to be successful (Long et al. 2013).
In the functional correction of hearing loss, bone conduction
hearing aids pose as first-line treatment. These systems have several
disadvantages – they are visible, cosmetically unappealing and
sometimes cause pain due to pressure being exerted on the skin
(Jafek et al. 1975; Lo et al. 2014).
An alternative to bone conduction hearing aids are hearing
implants (Colletti et al. 2006). These can be divided into middle ear
implants, including the VIBRANT SOUNDBRIDGEÔ (MED-EL
GmbH, Innsbruck, Austria) and CarinaÔ (Cochlear Ltd, New South
Wales, Australia), and bone conduction implants. The latter can be
either percutaneous, including the BahaÕ Connect (Cochlear Ltd.,
New South Wales, Australia) and PontoÔ (Oticon Medical AB,
Gothenburg, Sweden); passive transcutaneous like the BahaÔ
Attract (Cochlear Ltd., New South Wales, Australia) and
SophonoÔ Alpha (Sophono Inc., Boulder, CO) or active transcu-
taneous like the BonebridgeÔ (MED-EL GmbH, Innsbruck,
Austria). Percutaneous systems have an implanted skin-penetrating

Correspondence: Sofı́a Bravo-Torres, Unidad de Otorrinolaringologia, Servicio de Cirugia, Hospital Dr. Luis Calvo Mackenna, Santiago, Chile. E-mail: so.bravo@gmail.com

(Received 5 December 2016; revised 31 July 2017; accepted 7 August 2017)

ISSN 1499-2027 print/ISSN 1708-8186 online ß 2017 British Society of Audiology, International Society of Audiology, and Nordic Audiological Society
DOI: 10.1080/14992027.2017.1370137
 2 S. Bravo-Torres et al.
Abbreviations
dBHL Decibel hearing level
dB Decibel
kHz Kilohertz
PTA Pure tone average
BAHA Bone-anchored hearing aid
JUNAEB National School and Scholarship Assistance Council
SPL Sound Pressure Level
titanium screw with an external processor attached to it in order to
transmit vibrations to the inner ear (Park et al. 2016). While such
systems may have certain advantages over bone conduction hearing
aids, they also have their limitations: (1) permanent pillar percu-
taneous treatment is required to prevent skin problems; (2) skin
infections are recurrent; (3) feedback can limit the amplification
provided and (4) screw extrusions due to a failure to osseointegrate
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may require re-implantation (Huber et al. 2013).
The Bonebridge is the only active transcutaneous system
available in the market (MEDEL 2016). It consists of an
implantable coil and transducer that convert the delivered signals
into vibrations that are subsequently transmitted to the inner ear via
the skull (Sprinzl et al. 2013). Transcutaneous direct stimulation of
the bone minimises the risk of skin irritation and lends towards good
sound transmission (Sprinzl et al. 2013). As the implant lies
completely under the skin, it is not visible and complications rarely
occur (Reinfeldt et al. 2015; Sprinzl and Wolf-Magele, 2016).
There are several studies on adults showing improvements in
hearing thresholds and speech recognition with the Bonebridge
(Barbara et al. 2013; Rivas et al. 2013; Sprinzl et al. 2013;
Lassaletta et al. 2014). In 2014, the first paediatric cases were
documented, with clear improvements in hearing thresholds (func-
tional gain 430 dB), word recognition (Riss et al. 2014; Hassepass
et al. 2015; Rahne et al. 2015), sound localisation and speech
recognition in background noise (Plontke et al. 2014; Rahne et al.
2015). In addition, an improvement in quality of life has also been
documented in adults (Ihler et al. 2014; Bianchin et al. 2015).
A recent systematic review identified 29 studies that showed a
positive effect on hearing thresholds, speech recognition and patient
satisfaction in children and adults with various types of hearing loss
(Sprinzl and Wolf-Magele 2016).
The Bonebridge was approved for the European market in 2012
for use in adults and in 2014 for children above five years of age
(Reinfeldt et al. 2015). Despite being available for more than three
years, Baumgartner et al. (2016) are the only ones to have published
a repeated-measures study of paediatric patients (between 5 and 17
years) using the Bonebridge, in which the majority of the subjects
(10 out of 12) suffered from ear malformations.
This research is of particular interest for a country like Chile,
where outer ear malformations are four times more likely to occur
than the reported worldwide average (Nazer, Lay-Son, and
Cifuentes 2006). Moreover, the relatively high cost of this implant
means the most disadvantaged people in the country cannot afford
it. Funds provided by public institutions aim to provide equal access
for all from an early age. One purpose of this study was to provide
input for public policy in Chile, and also serve as a clinical
reference for other centres in the region.
Taking all these into consideration, the present study aimed to
assess the audiological outcomes of patients implanted with the
BonebridgeÔ. This involved a comparative description of perform-
ance at the different stages of the adaptation process: before surgery
unaided and with bone conducted hearing aids (BCHA), at switch-
on, and after a month of using the device.
Methods
Study design and participants
A retrospective case study was conducted using patients implanted
with the Bonebridge between 2014 and 2016. The medical records
of all implanted patients were reviewed at the Luis Calvo Mackenna
Hospital (N ¼ 15) after obtaining approval from the Ethics
Committee and gaining parental consent (including approval from
the children themselves). Since 2014, both the hospital and the
National School and Scholarship Assistance Council have incorpo-
rated the Bonebridge implant into their coverage plan. All implant
users were covered by the public health insurance system, which
does not require copayments for these benefits. Individuals were
considered candidates if they had bilateral conductive hearing loss
secondary to external ear malformations.
Surgery, activation and follow-up
Three surgical approaches are described in the literature: via the
mastoid, retro-sigmoid or middle fossa (Barbara et al. 2013;
Zernotti and Bravo 2015). The choice of surgical technique
depended on the patient’s anatomy and whether the ear was to be
reconstructed. The surgical approaches used in this group were via
the mastoid or middle fossa. The operation generally lasted about
1.5–2 hours under general anaesthesia and requires a day of
hospitalisation.
After four weeks, the implant was activated by fitting and
placing the audio processor on the head. A vibrogram was
performed using the Connexx 6.4.3 and Symfit 6.0 (St Suite 115,
Denver, CO) software. These tools allow for hearing thresholds to
be tested directly using the implant. A month after implant
activation, patients attended the hospital for reassessment and
follow-up. Audiometric thresholds in free field, word recognition
scores and hearing requirements were confirmed. Gain was
increased or decreased at specific frequencies according to
individual needs. After this procedure, performance was reassessed.
Audiological evaluation protocol
Hearing thresholds and word recognition scores were measured in
four different circumstances: before surgery unaided, with bone
conduction hearing aids, at switch on and a month after. Hearing
was evaluated by warble tones in the sound-field using an
Interacoustics AC-33 clinical audiometer (ANSI S3.6/1996). The
frequencies measured were 0.25, 0.5, 1, 2 and 4 kHz. Speech
perception was evaluated using phonetically-balanced monosyl-
lables, disyllables or spondees, and known terms in Spanish
(Rosemblut and De Cruz 1962). Known terms included common
words used in the spoken language. The word lists represented the
variety of phonemes that were phonetically balanced and belonged
to everyday vocabulary (Rosemblüt and De Cruz 1962). The tests
were performed in a sound-proof booth at 65 dB SPL using a
loudspeaker. Different word lists were presented at different test
intervals to avoid learning effect.
Statistical analysis
The patients’ average performance was described in terms of the
pure tone average, calculated over 0.5, 1.0, 2.0 and 4 kHz, and the
 Bravo S. active transcutaneous bone conduction implant 3

mean speech recognition score. This was carried out for each stage Table 1. Demographic and surgery-related characteristics of
of the adaptation process: before surgery unaided, with BCHA, at paediatric patients implanted with the Bonebridge system (N ¼ 15).
switch on and after a month of device use. For each value, 95% Age at time Associated Selected
confidence intervals were determined. No. of surgery pathology ear Complications Surgery
In order to compare performance, simple and multiple linear
1 11 None R Broken processor Mastoid
regression models were constructed. The dependent variables used 2 17 None L None Mastoid
were hearing thresholds and the percentage of correct word 3 17 None L Broken processor Mastoid
recognition. The different stages of the adaptation process were 4 7 Goldenhar R Broken processor Middle fossa
used as the predictive variable. Pairwise comparisons were made, 5 16 Goldenhar L None Middle fossa
with multiple comparisons being adjusted by Tukey’s test. The 6 8 None R Feedback Middle fossa
influence of specific frequencies or verbal material (monosyllabic, 7 8 Treacher collins R Feedback Middle fossa
disyllabic and known terms) was explored using interaction models. 8 6 None R Skin redness Middle fossa
Multilevel models for all the above calculations were used to 9 9 Treacher collins R Feedback Middle fossa
consider the correlation between measurements taken from the 10 12 None R None Middle fossa
11 15 None R None Middle fossa
same subject (Rabe-Hesketh and Skrondal 2012a). A random
12 6 None R Broken processors Middle fossa
intercept, corresponding to each subject, was specified. Multilevel 13 5 Piere robin R Skin redness Middle fossa
methods are more efficient than the analysis of the variance of
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14 12 None R Feedback Middle fossa

repeated measures, obtaining greater statistical power, which is
important in small samples such as in the present study
(Ma, Mazumdar, and Memtsoudis 2012). With the aim of
obtaining reliable confidence intervals, the asymptotic standard
errors of the fixed and random parameters were corrected, using
the so-called Huber/White or sandwich estimator (Huber and
Ronchetti 2009; White 1980). Inferences based on robust standard
errors (‘‘sandwich estimator’’) are less dependent on normal
distribution assumptions than the maximum likelihood (Maas and
Hox 2004). Moreover, it performs better when estimating the
standard errors of the variance of random effects than the
maximum likelihood when residuals are non-normal. The latter
is likely to occur in small samples such as in the present study
(Maas and Hox 2004). Finally, for all models, the assumption of
symmetrically distributed residuals was checked.
Trajectory performance in terms of hearing thresholds was
estimated using growth curve modelling (Rabe-Hesketh and
Skrondal 2012b), specifying an intercept and a random coefficient.
First, a linear model and then a non-linear piecewise model were
adjusted. In the latter, ‘‘knots’’ were created for each condition in
order to identify differences in the trajectories of different
frequencies.
Results
Demographic characteristics of the sample
The patients’ age ranged from 5 to 17 with an average of 11. Eight
were female and seven male. All were diagnosed with bilateral
microtia and congenital aural atresia and presented with moderate
bilateral conductive hearing loss. The most frequently implanted ear
was the right one. Four had congenital disorders (Treacher Collins
or Goldenhar syndrome). All were registered in the Chilean public
health system (National Health Fund) (Table 1).
Eight patients underwent a complete aesthetic reconstruction of
the ear at the time of implantation. Ear reconstruction is carried out
sequentially at 6 and 12 years of age and is independent from the
implantation of the Bonebridge.
Hearing thresholds
Before surgery, the average hearing threshold was 66.5 dBHL
(95%CI 64.2–68.9). When aided with a BCHA, an average
threshold of 35.8 dBHL was obtained (95%CI 32.5–39.1). With
the Bonebridge switched on, the average threshold was 31.0 dBHL
15 13 None L None Middle fossa
R: Right ear; L: Left ear.
(95%CI 28.2–33.8), decreasing to 25.2 dBHL (95%CI 23.5–26.9)
(Figure 1) after a month of use.
The greatest difference was observed when comparing the
average thresholds recorded before surgery and after the one month
follow-up (mean 41.3 dBHL; 95%CI 37.7–44.9; p50.001). This
was followed by the comparison between before surgery and switch
on (mean 35.5 dBHL; 95%CI 31.9–39.1; p50.001). There were
also significant differences in hearing thresholds when comparing
the one month follow-up to switch on (mean 5.8 dBHL; 95%CI 2.2–
9.4; p50.001) and the BCHA (mean 10.6 dBHL; 95%CI 7.0–14.2;
p50.001). The difference between preoperative hearing and BCHA
use was 30.7 dBHL on average (95% CI 27.1–34.3; p50.001);
and between BCHA use and switch on was 4.8 dBHL on average
(95% CI 1.2–8.4; p50.001).
Frequency-specific hearing thresholds at the different time
intervals are depicted in Figure 2. There was an interaction between
evaluation and sound frequency (2(12) ¼ 33.5; p50.001) – in
other words, the effect of the device was different depending on
frequency. At 0.25 kHz, the difference between the one month
follow-up and switch on was 4.0 dBHL (95%CI 0.4–7.6; p50.05).
At 0.5 kHz, the difference between the one month follow-up and
switch on was 4.3 dBHL, although this was not significant (95%CI
–0.3–9.0; p ¼ 0.069). There were significant differences in hearing
thresholds when comparing the one month follow-up with the
BCHA (mean 10 dBHL; 95%CI 5.6–14.4; p50.001). At 1 kHz,
there was a significant difference when comparing thresholds
between the one month follow-up and switch on (mean 8.7 dBHL;
95%CI 4.7–12.7; p50.01). The comparison between the BCHA and
switch on was not significant (mean 2 dBHL; 95%CI –3.1–7.1;
p ¼ 0.445). At 2 kHz, there were significant differences between the
one month follow-up and switch on (mean 5.6 dBHL; 95%CI
2.0–9.4; p50.01). At 4 kHz, all comparisons were found to be
significant. The difference between switch on and the BCHA
was on average 14.3 dBHL (95%CI 8.0–20.7; p50.001), and
between the one month follow-up and switch on was 6.3 dBHL
(95%CI 1.5–11.2; p50.05).
Finally, there were no significant differences between the
audiometric thresholds measured at the different time intervals
 4 S. Bravo-Torres et al.
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Figure 1. Audiometric thresholds in evaluation conditions. Mean values with 95% confidence intervals are shown.

Figure 2. Audiometric thresholds in the evaluation process for the 0.25–4 kHz frequency range. Mean values with 95% confidence
intervals are shown.

according to the surgical approach performed (medial fossa versus
mastoid) (p ¼ 0.562). Although the sample size was small, the
difference observed was not clinically relevant (51 dBHL).
Speech recognition
The overall average percentage of correct speech recognition before
surgery was 29.4% (95%CI 25.2–34.6); with the BCHA, this
reached 78.9% (95%CI 73.5–84.4). When the Bonebridge was
switched on, performance increased to 90.7% (95%CI 87.4–93.9)
and, a month afterwards, reached 96.4% (95%CI 92.7–100.2).
The greatest difference was observed when comparing the mean
recognition scores before surgery and after one month follow-up
(mean 67.0%; 95%CI 60.4–73.7; p50.001). This was followed by
the comparison between before surgery and switch on (mean 61.2%;
95%CI 54.6–67.9; p50.001). There was also a significant

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Figure 3. Results of the model showing the interaction between word recognition as verbal, material and evaluation condition variables.
Mean values with 95% confidence intervals are shown.
difference in speech scores when comparing the one month follow-
up to the BCHA (mean 17.5%; 95%CI 10.9–24.2; p50.001). There
was no significant difference between the scores from the one
month follow-up and switch on (mean 5.8; 95%CI 0.87–12.43;
p ¼ 0.113).
Speech recognition varied according to the type of material used.
On average, performance was significantly better when using
known terms rather than monosyllables (mean difference 9.1%;
95%CI 6.6–11.5; p50.001).
Speech scores obtained with the different verbal materials at the
different time intervals are presented in Figure 3. The interaction
between evaluation conditions and the verbal material used was
significant (2(6) ¼ 223.04; p50.001). There were statistically
significant differences in speech scores between evaluation condi-
tions when using monosyllables, with scores ranging from 19.6%
(95%CI 17.7–21.5; p50.001) to 2.1% (95%CI 1.3–2.9; p50.001).
For disyllabic words, the results were similar; however, the
differences between conditions were significant. For known terms,
statistically significant differences were observed for all the
comparisons except between switch on and one month follow-up
(mean 0.7% IC95% –0.04–1.4; p ¼ 0.065) (Figure 3).
Trajectory performance
While variations occur when estimating ‘‘linear growth curves,’’
several differences in the trajectories of hearing thresholds accord-
ing to sound frequency were observed (Figure 4). These differences
are evident when estimating non-linear trajectories through
piecewise models. For example, at 4 kHz, the difference between
before surgery and BCHA corresponded to 25.3 dBHL (95%CI
20.0–30.7; p50.001) and 14.3 dBHL between BCHA and switch on
(95%CI 8.0–20.7; p50.001). Fitting after one month of follow-up
led to a further improvement of 6.3 dBHL (95% CI 1.5–11.2;
p50.05). At 0.25 kHz, there was an increase of 32.3 dBHL (95% CI
Bravo S. active transcutaneous bone conduction implant 5
24.5–40.2; p50.001) from before surgery to BCHA use; fitting
after one month of follow-up led to a further significant improve-
ment of 4 dBHL (95% CI 0.4–7.6; p50.05). No statistically
significant improvements were recorded between the remaining
conditions (Figure 5).
Adverse events
Patients included in this study had no serious complications. The
most frequent complications were minor feedback (N ¼ 4), broken
processors (due to faults) before six months of use (N ¼ 4) and mild
skin redness (N ¼ 2). Feedback problems were resolved by
activating the audio processor’s feedback-cancelling algorithm. In
the cases of skin redness, as a precaution for possible complications
with the skin flap, the audio processor was removed for two to three
weeks and, if necessary, the magnet was swapped for one of a lower
strength.
Discussion
The outcomes of this study demonstrate the effectiveness of the
Bonebridge system. The average hearing threshold after one month
of device use was 25.2 dBHL (95%CI 23.5–26.9), with a narrowing
of the air-bone gap in every case. Hearing thresholds were better
than those with BCHAs at the frequencies important for speech
perception (0.5–4 kHz). The best performance was at 4 kHz,
with improvements in hearing throughout the adaptation process
(Figure 2).
The Bonebridge had a better performance than the BCHA, which
can be explained by direct, transcutaneous stimulation of the skull.
BCHAs produce and exert exterior sound energy on to the skin; the
skin then conveys these vibrations to the inner ear. With the direct
stimulation of the skull in transcutaneous bone conduction implants,
5–15 dBHL improvement in sensitivity at 1 kHz and above can be
 6 S. Bravo-Torres et al.
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Figure 4. Predicted and observed linear growth curves for the pure tone thresholds of frequencies evaluated in the four conditions
(1st ¼ before surgery unaided, 2nd ¼ and with bone conducted hearing aids, 3rd ¼ switch on and 4th ¼ after a month of device use).

Figure 5. Non-linear growth curves (piecewise) predicted for 0.250 and 4 kHz in the four conditions (1st ¼ before surgery unaided,
2nd ¼ and with bone conducted hearing aids, 3rd ¼ switch on and 4th ¼ after a month of device use). Mean values with 95% confidence
intervals are shown.

expected (Stenfelt 2011). Another factor that contributes to
improved performance could be the shorter distance between the
point of vibration and the inner ear. Studies have shown that
positioning a bone conduction transducer closer to the ear canal and
inner ear improves sound transmission (Eeg-Olofsson et al. 2008,
2011; Häkansson et al. 2008; Rivas et al. 2013), leading to better
hearing (Reinfeldt et al. 2014).
Comparisons between BCHA implementation and the switched
on Bonebridge showed no significant differences in hearing
thresholds between 0.5 kHz and 2 kHz. This is essentially in line

with therapeutic expectations. Changes at these frequencies will
probably be seen after one month of use, when the device is
calibrated and checked. Significant improvements in hearing at
4 kHz at all stages of the adaptation process could be an important
consideration in further adjustment and fitting of the device.
In terms of word recognition, there was a significant improve-
ment with the Bonebridge compared to the BCHA. An average
score of 96.4% was obtained after one month of use. The most
effective verbal material was monosyllabic word lists, which were
more sensitive to differences in performance. This could be
explained by their characteristics in Spanish: Monosyllabic words
are rare in spontaneous speech and, since they do not involve
contextual or semantic cues, recognition is mainly auditory.
As mentioned before, there is only one clinical trial
(Baumgartner et al. 2016) that has included paediatric patients
with similar characteristics to those in this study. Those authors
reported significant improvements in speech perception and func-
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tional gain with the Bonebridge. The individuals with better hearing
performance included in this study were those with a pure
conductive hearing loss who exhibited a maximum air-bone gap
(60 dBHL).
Riss et al. (2014) evaluated 11 patients with atresia, of whom six
were under 18 years of age and exhibited a functional gain of
32.5 ± 14.3 dBHL. The lower gain and greater variability compared
to our study could be explained by some of the subjects having
mixed hearing loss (Riss et al. 2014). Ihler et al. (2014) assessed six
adult patients with conductive and mixed hearing losses, whose
functional gain was lower than that obtained in the present series,
with an average of 34.5 ± 6.9 dBHL. Preoperative air conduction
thresholds were slightly lower than in our series, averaging
58.8 ± 8.2 dBHL, and half of the patients had bone conduction
thresholds between 26–34.5 dBHL. This could be due to the fact
that patients with radical operations were included in the study.
In this study, only minor complications were observed and all of
these were resolved during the adaptation process. The most
common complication was feedback. With a transcutaneous system
feedback is less likely to occur, due to the higher impedance of the
mechanical signal transmitted from the processor microphone
(Taghavi et al. 2012). Another frequent minor complication was
technical faults and failure of the audio processors before six
months of use (N ¼ 4). This complication is not surprising, given
that the processor is a small, lightweight device that uses magnets to
hold it against the skin; and that children and adolescents have an
active lifestyle. Various solutions have been developed; the most
effective one in this sample was the use of a hair clip.
It is important to mention that monitoring and check-ups are
essential for preventing further complications. Major complications
have been identified regarding the surgical requirements inherent to
any implantable device, with the most common being related to the
skin flap (Zernotti and Bravo 2015). There is the possibility that an
implant presses on the meninges; however, no up-to-date report has
indicated a higher prevalence of headaches and/or cranial pressure
in the implanted population (Zernotti and Bravo 2015). The long-
term side effects of vibrations on the dura matter and on the sigmoid
sinus are unknown; therefore, more follow-up studies are required.
Limitations and projections
In this study, outcomes were collected within a month after
implantation; there is a need to follow-up patients to assess if
performance varies over time. The data collected here comes from
Bravo S. active transcutaneous bone conduction implant 7
patients presenting with rare, severe ear malformations. There is a
limited amount of literature related to this new device and therefore
it is difficult to compare results.
Since some of the patients have not yet completed their aesthetic
treatment, it is not known how this could affect their audiological
performance. Patients who have undergone the full course of
treatment (plastic and ear surgery) have reported no significant
changes.
We are in the process of assessing patient satisfaction, as well as
speech recognition in noise; both involve validating instruments in
Spanish for the paediatric population. It is also necessary to evaluate
the impact this device could have on children’s performance at
school.
Finally, as the Bonebridge has only recently become available
on the national market, it was not possible to compare it to a
preoperatively worn headband in the majority of patients. It would
be interesting to compare performance with the preoperative
headband to that observed in the post-operative period. Future
research should address this issue.
Conclusion
In the present study, the Bonebridge implant system provided an
overall improvement in hearing thresholds and word recognition. In
addition, improved hearing was demonstrated in the low (0.5 and
1 kHz) and high frequencies (mainly 4 kHz) when compared to the
BCHA. This indicates that the Bonebridge is a viable alternative for
the treatment of paediatric patients with congenital conductive
hearing loss. Early hearing rehabilitation provides access to speech
sounds and is important for auditory development and improving
the quality of life (Fan et al. 2013). Patients should continue to be
monitored to determine how hearing improvements affect school
performance and everyday life.
Acknowledgements
The authors thank the Otorhinolaryngology Unit at the Dr. Luis
Calvo Mackenna Hospital and the Student Health Program of the
National School and Scholarship Assistance Council (JUNAEB),
both of whom are sponsors of the hearing implant programme. They
are also thankful to Melodi Kosaner Kliess from MEDEL (Austria)
for her help in language editing of the manuscript.
Declaration of interest: This study did not receive any funding.
Eduardo Fuentes-López received support from the National
Commission for Scientific and Technological Research
(CONICYT) for pursuing doctoral studies in Chile.
The authors declare they had no conflicts of interest in
conducting this study.
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