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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
Original Article
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
disadvantages – they are visible, cosmetically unappealing and
Atresia of the external auditory canal affects one in every 10,000– sometimes cause pain due to pressure being exerted on the skin
20,000 live births. It is mostly present unilaterally (only 30% is (Jafek et al. 1975; Lo et al. 2014).
bilateral), in men and in the right ear (Jafek et al. 1975; Kelley and An alternative to bone conduction hearing aids are hearing
Scholes 2007; El-Begermy et al. 2009); and can be associated with implants (Colletti et al. 2006). These can be divided into middle ear
microtia (Lo et al. 2014). A large percentage occurs in isolation, implants, including the VIBRANT SOUNDBRIDGEÔ (MED-EL
while associated forms often have genetic causes as part of GmbH, Innsbruck, Austria) and CarinaÔ (Cochlear Ltd, New South
craniofacial disorders (Nazer, Lay-Son, and Cifuentes 2006). Wales, Australia), and bone conduction implants. The latter can be
Varying degrees of conductive hearing loss are present in either percutaneous, including the BahaÕ Connect (Cochlear Ltd.,
80–90% of patients (Siegert, Matthies, and Kasis 2007). New South Wales, Australia) and PontoÔ (Oticon Medical AB,
An aesthetic and functional approach can be adopted in treating Gothenburg, Sweden); passive transcutaneous like the BahaÔ
patients with atresia and microtia. Reconstructive surgery with Attract (Cochlear Ltd., New South Wales, Australia) and
autologous cartilage has shown to be successful (Long et al. 2013). SophonoÔ Alpha (Sophono Inc., Boulder, CO) or active transcu-
In the functional correction of hearing loss, bone conduction taneous like the BonebridgeÔ (MED-EL GmbH, Innsbruck,
hearing aids pose as first-line treatment. These systems have several 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
Abbreviations unaided and with bone conducted hearing aids (BCHA), at switch-
dBHL Decibel hearing level on, and after a month of using the device.
dB Decibel
kHz Kilohertz Methods
PTA Pure tone average
BAHA Bone-anchored hearing aid Study design and participants
JUNAEB National School and Scholarship Assistance Council A retrospective case study was conducted using patients implanted
SPL Sound Pressure Level 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
titanium screw with an external processor attached to it in order to Committee and gaining parental consent (including approval from
transmit vibrations to the inner ear (Park et al. 2016). While such the children themselves). Since 2014, both the hospital and the
systems may have certain advantages over bone conduction hearing National School and Scholarship Assistance Council have incorpo-
aids, they also have their limitations: (1) permanent pillar percu- rated the Bonebridge implant into their coverage plan. All implant
taneous treatment is required to prevent skin problems; (2) skin users were covered by the public health insurance system, which
infections are recurrent; (3) feedback can limit the amplification does not require copayments for these benefits. Individuals were
provided and (4) screw extrusions due to a failure to osseointegrate
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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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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 reached 78.9% (95%CI 73.5–84.4). When the Bonebridge was
mastoid) (p ¼ 0.562). Although the sample size was small, the switched on, performance increased to 90.7% (95%CI 87.4–93.9)
difference observed was not clinically relevant (51 dBHL). 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
Speech recognition (mean 67.0%; 95%CI 60.4–73.7; p50.001). This was followed by
The overall average percentage of correct speech recognition before the comparison between before surgery and switch on (mean 61.2%;
surgery was 29.4% (95%CI 25.2–34.6); with the BCHA, this 95%CI 54.6–67.9; p50.001). There was also a significant
Bravo S. active transcutaneous bone conduction implant 5
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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- 24.5–40.2; p50.001) from before surgery to BCHA use; fitting
up to the BCHA (mean 17.5%; 95%CI 10.9–24.2; p50.001). There after one month of follow-up led to a further significant improve-
was no significant difference between the scores from the one ment of 4 dBHL (95% CI 0.4–7.6; p50.05). No statistically
month follow-up and switch on (mean 5.8; 95%CI 0.87–12.43; significant improvements were recorded between the remaining
p ¼ 0.113). conditions (Figure 5).
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%; Adverse events
95%CI 6.6–11.5; p50.001). Patients included in this study had no serious complications. The
Speech scores obtained with the different verbal materials at the most frequent complications were minor feedback (N ¼ 4), broken
different time intervals are presented in Figure 3. The interaction processors (due to faults) before six months of use (N ¼ 4) and mild
between evaluation conditions and the verbal material used was skin redness (N ¼ 2). Feedback problems were resolved by
significant (2(6) ¼ 223.04; p50.001). There were statistically activating the audio processor’s feedback-cancelling algorithm. In
significant differences in speech scores between evaluation condi- the cases of skin redness, as a precaution for possible complications
tions when using monosyllables, with scores ranging from 19.6% with the skin flap, the audio processor was removed for two to three
(95%CI 17.7–21.5; p50.001) to 2.1% (95%CI 1.3–2.9; p50.001). weeks and, if necessary, the magnet was swapped for one of a lower
For disyllabic words, the results were similar; however, the strength.
differences between conditions were significant. For known terms,
statistically significant differences were observed for all the
Discussion
comparisons except between switch on and one month follow-up
(mean 0.7% IC95% –0.04–1.4; p ¼ 0.065) (Figure 3). 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
Trajectory performance of the air-bone gap in every case. Hearing thresholds were better
While variations occur when estimating ‘‘linear growth curves,’’ than those with BCHAs at the frequencies important for speech
several differences in the trajectories of hearing thresholds accord- perception (0.5–4 kHz). The best performance was at 4 kHz,
ing to sound frequency were observed (Figure 4). These differences with improvements in hearing throughout the adaptation process
are evident when estimating non-linear trajectories through (Figure 2).
piecewise models. For example, at 4 kHz, the difference between The Bonebridge had a better performance than the BCHA, which
before surgery and BCHA corresponded to 25.3 dBHL (95%CI can be explained by direct, transcutaneous stimulation of the skull.
20.0–30.7; p50.001) and 14.3 dBHL between BCHA and switch on BCHAs produce and exert exterior sound energy on to the skin; the
(95%CI 8.0–20.7; p50.001). Fitting after one month of follow-up skin then conveys these vibrations to the inner ear. With the direct
led to a further improvement of 6.3 dBHL (95% CI 1.5–11.2; stimulation of the skull in transcutaneous bone conduction implants,
p50.05). At 0.25 kHz, there was an increase of 32.3 dBHL (95% CI 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 2011; Häkansson et al. 2008; Rivas et al. 2013), leading to better
improved performance could be the shorter distance between the hearing (Reinfeldt et al. 2014).
point of vibration and the inner ear. Studies have shown that Comparisons between BCHA implementation and the switched
positioning a bone conduction transducer closer to the ear canal and on Bonebridge showed no significant differences in hearing
inner ear improves sound transmission (Eeg-Olofsson et al. 2008, thresholds between 0.5 kHz and 2 kHz. This is essentially in line
Bravo S. active transcutaneous bone conduction implant 7
with therapeutic expectations. Changes at these frequencies will patients presenting with rare, severe ear malformations. There is a
probably be seen after one month of use, when the device is limited amount of literature related to this new device and therefore
calibrated and checked. Significant improvements in hearing at it is difficult to compare results.
4 kHz at all stages of the adaptation process could be an important Since some of the patients have not yet completed their aesthetic
consideration in further adjustment and fitting of the device. treatment, it is not known how this could affect their audiological
In terms of word recognition, there was a significant improve- performance. Patients who have undergone the full course of
ment with the Bonebridge compared to the BCHA. An average treatment (plastic and ear surgery) have reported no significant
score of 96.4% was obtained after one month of use. The most changes.
effective verbal material was monosyllabic word lists, which were We are in the process of assessing patient satisfaction, as well as
more sensitive to differences in performance. This could be speech recognition in noise; both involve validating instruments in
explained by their characteristics in Spanish: Monosyllabic words Spanish for the paediatric population. It is also necessary to evaluate
are rare in spontaneous speech and, since they do not involve the impact this device could have on children’s performance at
contextual or semantic cues, recognition is mainly auditory. school.
As mentioned before, there is only one clinical trial Finally, as the Bonebridge has only recently become available
(Baumgartner et al. 2016) that has included paediatric patients on the national market, it was not possible to compare it to a
with similar characteristics to those in this study. Those authors preoperatively worn headband in the majority of patients. It would
reported significant improvements in speech perception and func- be interesting to compare performance with the preoperative
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tional gain with the Bonebridge. The individuals with better hearing headband to that observed in the post-operative period. Future
performance included in this study were those with a pure research should address this issue.
conductive hearing loss who exhibited a maximum air-bone gap
(60 dBHL).
Riss et al. (2014) evaluated 11 patients with atresia, of whom six Conclusion
were under 18 years of age and exhibited a functional gain of In the present study, the Bonebridge implant system provided an
32.5 ± 14.3 dBHL. The lower gain and greater variability compared overall improvement in hearing thresholds and word recognition. In
to our study could be explained by some of the subjects having addition, improved hearing was demonstrated in the low (0.5 and
mixed hearing loss (Riss et al. 2014). Ihler et al. (2014) assessed six 1 kHz) and high frequencies (mainly 4 kHz) when compared to the
adult patients with conductive and mixed hearing losses, whose BCHA. This indicates that the Bonebridge is a viable alternative for
functional gain was lower than that obtained in the present series, the treatment of paediatric patients with congenital conductive
with an average of 34.5 ± 6.9 dBHL. Preoperative air conduction hearing loss. Early hearing rehabilitation provides access to speech
thresholds were slightly lower than in our series, averaging sounds and is important for auditory development and improving
58.8 ± 8.2 dBHL, and half of the patients had bone conduction the quality of life (Fan et al. 2013). Patients should continue to be
thresholds between 26–34.5 dBHL. This could be due to the fact monitored to determine how hearing improvements affect school
that patients with radical operations were included in the study. performance and everyday life.
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 Acknowledgements
feedback is less likely to occur, due to the higher impedance of the
mechanical signal transmitted from the processor microphone The authors thank the Otorhinolaryngology Unit at the Dr. Luis
(Taghavi et al. 2012). Another frequent minor complication was Calvo Mackenna Hospital and the Student Health Program of the
technical faults and failure of the audio processors before six National School and Scholarship Assistance Council (JUNAEB),
months of use (N ¼ 4). This complication is not surprising, given both of whom are sponsors of the hearing implant programme. They
that the processor is a small, lightweight device that uses magnets to are also thankful to Melodi Kosaner Kliess from MEDEL (Austria)
hold it against the skin; and that children and adolescents have an for her help in language editing of the manuscript.
active lifestyle. Various solutions have been developed; the most
effective one in this sample was the use of a hair clip. Declaration of interest: This study did not receive any funding.
It is important to mention that monitoring and check-ups are Eduardo Fuentes-López received support from the National
essential for preventing further complications. Major complications Commission for Scientific and Technological Research
have been identified regarding the surgical requirements inherent to (CONICYT) for pursuing doctoral studies in Chile.
any implantable device, with the most common being related to the The authors declare they had no conflicts of interest in
skin flap (Zernotti and Bravo 2015). There is the possibility that an conducting this study.
implant presses on the meninges; however, no up-to-date report has
indicated a higher prevalence of headaches and/or cranial pressure
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