International Journal of Pediatric Otorhinolaryngology 79 (2015) 382–387

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International Journal of Pediatric Otorhinolaryngology

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

Hearing rehabilitation with the closed skin bone-anchored implant

Sophono Alpha1: Results of a prospective study in 15 children with
ear atresia§
Françoise Denoyelle a,*, Cyrille Coudert a,b, Briac Thierry a, Marine Parodi a,
Olivia Mazzaschi a, Eric Vicaut c, Natacha Tessier c, Natalie Loundon a,
Eréa-Noël Garabedian a
a
Otolaryngology—Head and Neck Surgery Department, Necker-Enfants Malades Children Hospital and Paris-Descartes University, Inserm U-587, Paris, France
b
AudionovaTM Audiometry Center, 75015 Paris, France
c
Unité de Recherche Clinique—Centre d’évaluation des dispositifs médicaux, APHP, Université Paris-Diderot Paris V, Paris, France

A R T I C L E I N F O A B S T R A C T

Article history: Objective: To study gain and cutaneous tolerance of the Sophono Alpha1 implant, used for unilateral
Received 29 October 2014 hearing rehabilitation in children with ear atresia, and to demonstrate non-inferiority compared to the
Received in revised form 26 December 2014 referral closed skin device, BAHA1 on a test-band.
Accepted 27 December 2014
Methods and materials: Fifteen children included in a prospective clinical trial from September 2010 to
Available online 3 January 2015
November 2012. Tertiary care center. Main outcomes: Pure tone and speech audiometry before surgery
and at M6 and 12; Speech-in-noise tests with and without Alpha1 at M6. Quality of life questionnaire
Keywords:
completed before surgery and at M6; children and parent’s satisfaction assessed at M6. Cutaneous
Congenital aural atresia
appearance assessed at M6, M12 and during the last clinical assessment.
Children
Conductive hearing loss Results: Patients’ ages ranged from 61 to 129 months. They had a pure conductive deafness with a mean
Sophono Alpha1 air conduction pure-tone average (ACPTA) of 69.02  9.31 dB, and a mean SRT of 71.73  9.20 dB. Follow-
Bone anchored hearing device up was 12–32 months. At M6, the mean aided ACPTA was 33.49  4.89 dB, the mean aided SRT
38.27  4.54 dB and the mean aided SRT in noise was statistically improved ( 7.80 dB). Sophono Alpha1
demonstrated non-inferiority compared to BAHA1 on a test-band. At M12, mean aided ACPTA was 2.94 dB
higher (p < 0.001) but the mean SRT variation (+0.73 dB) was not significantly different (p = 0.35).
At M12, all children used the implant 5 to 12 h daily (mean: 10) without cutaneous complications.
Both children and parents reported being satisfied or very satisfied. The score for 7/10 questions in
silence or noisy environment was statistically improved when wearing the device.
Conclusions: This prospective study demonstrate non inferiority, good cutaneous tolerance, satisfaction
of children and parents and improvement of the quality of life with the Sophono Alpha1 compared to
BAHA1 on a test-band. In the light of this study and of the previously published series, the aided
threshold is between that obtained with BAHA on a softband and percutaneous BAHA. The Sophono
Alpha1 device needs to be part of the hearing solutions proposed for the hearing rehabilitation in
children with ear atresia.
ß 2015 Elsevier Ireland Ltd. All rights reserved.

Introduction

Congenital aural atresia with complete absence of the external

§
IRB disclosure: All the authors of this article certify to have no financial interest
or involvement of any kind in the subject matter or materials discussed in this
manuscript. The 15 Alpha1 implants have been provided by Collin Medical Inc,
Bagneux, France.
* Corresponding author. Tel.: +33 0 171396785; fax: +33 0 171396700.
E-mail addresses: f.denoyelle@nck.aphp.fr, secretariat.denoyelle@nck.aphp.fr
(F. Denoyelle).
auditory canal (EAC) is usually associated with an isolated, moderate
to severe conductive hearing loss. Correction by conventional
hearing devices is impossible because of the absence of EAC and/or
severe pinna’s malformations. An external hearing aid (head band
vibrator, BAHA1 or Ponto1 Softband) can be used during the first
years of life. In 2008, Verhagen [1] reported a gain of 33  6 dB with a

http://dx.doi.org/10.1016/j.ijporl.2014.12.032
0165-5876/ß 2015 Elsevier Ireland Ltd. All rights reserved.
 F. Denoyelle et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 382–387
Softband BAHA1 in 12 atresia children with an air conduction pure
tone average (ACPTA) loss of 60 dB.
For esthetical and functional reasons, changing the hearing aid
device is usually necessary at 5–6 years of age: the actual
reference technique is the bone anchored hearing aid with
percutaneous implantation (worn on an abutment). First
described by Tjellstrom [2] more than 20 years ago numerous
reports about its efficiency have been published since. The
surgical procedure requires general anesthesia in children and
can be conducted, depending on the surgical team, in one or two
stages. The external processor is clipped on the abutment not
before 4 to 6 months of healing, in order to allow sufficient
osseointegration. Cutaneous complications and implant displace-
ment or loosening are the major concerns after implantation of
percutaneous implants, especially in children. In large series of
pediatric patients, the rate of severe cutaneous complications is
estimated to be between 9.4 and 37% and between 14 and 25.9%
for a loss of the abutment [3–6]. The broad range of the incidence
of complications is probably caused by variability of the criteria
defining each complication.
The Sophono Alpha 1 bone-anchored implant is a transcuta-
neous (closed-skin) magnet-based vibrating implanted hearing
device with an external processor held in place by the magnet. It
has originally been developed in Germany since 2004 by Dr
Siegert [7] and is since 2010 produced by Sophono Inc. (Boulder,
Colorado, USA). An external sound processor transmits vibra-
tions directly through the skin into the bone, mediated by an
AttractTM base plate located between the external device and the
skin. The AttractTM base plate is held in place by a magnetic
implant carrying two magnets attached to the bone with five
small screws. The AttractTM base plate allows to modify the
magnetic attraction controlling pressure on the skin (Fig. 1). Six
intensities are available (0 to 5), the higher the stronger. The
largest pediatric series is a retrospective analysis in 10 children
(14 ears) [8]. So far, no prospective study with a comparable
follow-up protocol has been conducted on pediatric patients. We
present here the results at months 6 and 12 (M6 and M12) and
during the last assessment (12–32 months) after surgery of the
Sophono Alpha1 bone-anchored hearing device in 15 children
with high grade ear atresia, including a non-inferiority statistical
analysis comparing the Alpha1 system to the BAHA1 on a test-
band.
Fig. 1. Implant placement. Placement of the implant in a site of implantation as flat as
possible, in order to avoid bending of the double magnet.
383
Fig. 2. Appearance of the skin in case no. 13. Aspect of the skin facing the magnets in
one of the two cases with pink coloration and depigmentation, 12 months after
implantation.
Materials and methods
This study is a prospective monocentric clinical trial. It has been
approved and registered (no. 10807) by the institutional review
board of our institution (CPP Ile-de-France). It includes a non-
inferiority clinical trial to compare the auditory results of the
Sophono Alpha1 implant to those obtained with the referral closed
skin bone conduction device existing at the beginning of this study,
the Softband BAHA1, in a same patient.
Inclusion was proposed for unilateral hearing rehabilitation to
patients (and their parents) aging from 5 to 18 years presenting
with a uni- or bilateral congenital aural atresia with complete
absence of the EAC, and with a pure conductive hearing loss. All
patients had previously undergone a routine checkup including
temporal bone CT-scan and conventional audiometry. Informed
consent was given by all parents.
Exclusion criteria were: presence of a cutaneous disease
prohibiting the use of the external auditory processor; mental
impairment or behavioral disorder prohibiting the realization of
the auditory testing; and the need of a follow-up by MRI.
The preoperative evaluation included:
- a pure tone testing of thresholds by air and bone conduction and
speech reception thresholds,
- a free field air conduction testing with a BAHA1 sound processor
BP100 on a test-band, and
- a quality of life questionnaire (see below).
The surgical procedure was performed under general anesthe-
sia, eventually coupled with a second procedure of ear reconstruc-
tion. The site of implantation was chosen to be as flat as possible.
Two bone beds 2 mm deep were created to host the implant and
magnets were secured by 5 screws of 1.5 mm in diameter and
3.5 mm in length (Fig. 1). Skin was closed with absorbable sutures.
The first use of the external device was scheduled one month after
the procedure.
The evaluation 6 months after implantation (M6) included:
- a clinical examination with special care to the aspect of the skin over
the implanted magnets, allowing grade appearance (normal, pink,
red, crust, necrosis), pain with pressure (yes, no), depilation (yes, no),
- a tonal and vocal air conduction audiometry in free field with
masking of the contralateral ear, with and without Alpha1,
384 F. Denoyelle et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 382–387
- a speech-in-noise test with and without Alpha1, in ‘‘real-life’’
conditions: without contralateral masking and using a contra-
lateral hearing device if used pre-operatively; The speech
discrimination test was performed in free field, with the signal
coming from the front speaker and the noise in coming from two
lateral speakers, noise at 65 dB, increasing signal to determine
the 50% intelligibility threshold (Sound Reception Threshold,
SRT), and
- a quality of life and a satisfaction questionnaire.
The evaluation 12 months after implantation (M12) included:
- a clinical examination with special care to the aspect of the skin
over the implanted magnets; and
- A tonal and vocal air conduction audiometry in free field with
masking of the contralateral ear, with Alpha1.
The quality of life questionnaire was derived from the parent
report scales MUSS (Meaningful Use of Speech Scale, designed to
assess the child’s use of speech in everyday situations, described by
Robbins AM and Osberger MJ at the meeting of American speech–
language–hearing Association, November 1991, Atlanta, USA) and
MAIS (Meaningful Auditory Integration Scale) [9], designed to
assess the child’s spontaneous responses to sound in his/her
everyday environment) and adapted to the very homogeneous
population of the study, affected by moderate–severe conductive
deafness. The questionnaire was completed by the families before
surgery and at M6: 10 questions, answer from 0 to 4 ((0) never, (1)
rarely, (2) quite often, (3) often, (4) always).
- Five questions concerns behavioral observation in a calm
environment: does your child Q1 hear you when you call him/
her, Q3 hear background noises, Q4 localize the surrounding
noises, Q6 understands normal speech, Q8 is able to participate to
a long discussion?
- Four questions concerns noisy environment: Q2 hear you when
you call him/her, Q5 does your child localize the surrounding
noises,Q7 understand speech, Q9 understand speech in a family
meeting?
- Question on intelligibility of the child: Q10 is your child
understood by people outside the family?
The satisfaction questionnaire was completed at M6.
1. How often does your child use his/her Alpha1 implant? (0)
never; (1) sometimes; (2) often; (3) very often; (4) permanently.
2. Is your child satisfied of his/her Alpha1 implant? (0) no, very
dissatisfied; (1) rather dissatisfied; (2) moderately satisfied; (3)
yes, satisfied; (4) yes, very satisfied.
3. Are you, parents, satisfied of your child’s Alpha1 implant? (0) no,
very dissatisfied; (1) rather dissatisfied; (2) moderately satis-
fied; (3) yes, satisfied; (4) yes, very satisfied.
Results were presented as mean  SD and statistical comparison
used Wilcoxon’s test. A p lower than 0.05 was considered significant.
The non-inferiority trial compares Sophono Alpha1 to the
reference closed skin technique (BAHA1 on a test-band). The non-
inferiority hypothesis was tested on the main efficacy criterion i.e.
the variation of mean value of air conduction in tonal audiometry
(on 0.5, 1, 2 and 4 kHz) between initial assessment (BAHA1, before
surgery) and 6 month assessment with Sophono Alpha1. The non-
inferiority will be demonstrated if the upper limit of the 95%
confidence interval of this difference is lower than the clinical
equivalence margin which was set to D = 8.25 dB, i.e. around 25%
of a clinically pertinent gain as judged by experts. H0: dREF-OTO  D
versus alternative hypothesis Ha: dREF-OTO < D.
Considering a clinical equivalence margin of 8.25 dB and a
standard deviation of the main efficacy criterion around 9 dB, a
sample size of 15 patients will allow to demonstrate the non-
inferiority with a 90% power using confidence intervals method.
Results
Fifteen patients were included, 8 boys and 7 girls, aged 61 to
129 months, median age 97 months (Table 1). The mean (0.5–
4 kHz) air conduction pure tone average (ACPTA) threshold of the
atretic ear was 69.02  9.31 dB, the bone conduction pure tone
average (BCPTA) threshold was 11.17  5.45 dB, and the mean SRT
was 71.73  9.20 dB. Preoperatively, ACPTA with the BAHA1 on a
testband ranged from 25 to 44.4 dB, mean 32.89  5.86 dB.
Eleven children had a normal or near normal contralateral
hearing; 3 children (no. 1, no. 11, no. 13) had contralateral low
grade ear atresia and ossicular anomalies, with an ear canal and
pinna allowing to wear a classic air conduction device; one child
(no. 10) had a high grade contralateral atresia, rehabilitated by
middle ear implant (Sophono implantation choosen on this side
because of highly malformed ear); the mean ACPTA threshold of
the contralateral ear was 29  21.47 dB with a normal bone
conduction (6.92  4.74 dB) (Tables 1 and 2).
We experienced no surgical complications neither during the
procedure nor in the post-operative period. The bone thickness
was always sufficient for drilling the bone beds. All patients were
discharged home the day following the procedure, except for the
two who underwent in the same time a second stage of external ear
reconstruction. The external devices were adapted one 23 to
48 days after surgery, median 32 days.
At M6, free field testing with contralateral masking showed a
mean aided ACPTA of 33.49  4.89 dB (mean gain 35.53 dB) and a
mean aided SRT of 38.27  4.54 dB (mean SRT gain 33.47 dB). Using
speech-in-noise tests in real life conditions, (free field without
contralateral masking) at M6 the mean SRT was statistically improved
with Alpha1 ( 7.80  4.11 dB, p = 0.0313) (Table 3). At M12, free field
testing with contralateral masking showed a mean aided ACPTA of
36.43  4.61 dB, and a mean aided SRT of 39  5.86 dB. The variation
with M6 ACPTA (+2.94 dB) was statistically significant (p < 0.0001)
but not the SRT variation (+0.73, p = 0.35).
As shown in Table 4, the mean difference between ACPTA with
the test-band BAHA1 and Sophono Alpha1 after 6 months was
equal to 0.6 dB and the upper limit of the 95% confidence interval
was equal to 4.42 dB. Since this value was lower than the a priori
defined non-inferiority margin (i.e. 8.25 dB), the non-inferiority of
Sophono Alpha1 compared to Soft-Band BAHA1 was demon-
strated.
Comparing the answers to the quality of life questionnaire
completed before surgery and at M6 (children wearing their
Alpha1):
- 3 Out of 5 items in a quiet environment were improved: hear you
when you call him/her’’ (p = 0.0156), ‘‘localize the surrounding
noises’’ (p = 0.0156), ‘‘is able to participate to a long discussion’’
(p = 0.0137). The improvement of ‘‘hearing of background noises’’
and ‘‘comprehension of normal speech’’ were not statistically
significant (47 to 52/60 and 48 to 54/60, items with the higher
preoperative scores).
- 3 Out of 4 items in a noisy environment were improved: ‘‘hear
you when you call him/her’’ (p = 0.0010), ‘‘localize the surround-
ing noises’’ (p = 0.0005), ‘‘understand speech in a family meeting’’
(p = 0.090). The improvement of ‘‘comprehension of normal
speech’’ in noise was not statistically significant (34/60 to 37/60)
- Finally, the score to the question ‘‘Is your child understood by
people outside the family?’’ was significantly improved
(p = 0.0078).
Table 1
Clinical data.

Patient Side Male/ Age at Hearing Complications Month 12 post surgery Skin covering the implant at month 12 Adverse effects due Last assessment
number female surgery aid fitting until hearing to the wearing of
Intensity Duration (h) Appearance Depilation Pain Time from Duration (h)
(months) (days after aid fitting the device
of the of wearing (N: normal, surgery of wearing
surgery)
magnet (0–5) of the pink, red, (months) of the
device per day crust, necrosis) device per day

No. 1 Right M 105 34 No 2 12 N No No First month of wearing 31 12

F. Denoyelle et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 382–387

(continuous wearing):
skin edema,
inflammation and pain.
Stopped wearing 8
days, less powerfull
magnet
No. 2 Right F 86 35 No 1 9 Pink Yes No Second month of 32 9
wearing (continuous
wearing):
inflammation and pain.
Stop wearing 8 days,
less powerfull magnet
No. 3 Left F 73 35 No 1 5 N No No Stopped wearing the 29 0
hearing aid at month 15
(social problems, lost to
follow-up 18 months)
No. 4 Left M 104 28 No 1 12 Pink No No No 28 12
No. 5 Right F 82 30 No 0 10 Pink No No No 22 10
No. 6 Right M 119 37 No 1 10 N No No Some brief episodes of 28 12
pain, no need to remove
of the device
No. 7 Right M 155 42 No 2 11 N No No At month 13, refused to 18 0
wear the device,
discumfort and esthetic
problem
No. 8 Right M 105 28 No 0 6 N No No No 19 6
No. 9 Right F 61 29 No 0 11 N No No No 19 11
No. 10 Right M 97 32 No 1 5 N No No No 20 5
No. 11 Left F 87 36 No 2 8 N No No Several failures of the 12 8
external device
No. 12 Left F 129 28 No 3 6 N No No Some episodes of 16 6
redness needing to stop
wearing 1 day
No. 13 Right F 70 23 No 0 and 1 12 Pink Yes No No 12 12
No. 14 Left M 91 32 No 0 and 1 6 Pink No No Some episodes of 12 6
tingling of the skin,
needing to remove the
device a few minutes
No. 15 Right M 124 30 No 1 5 N No No No 12 5

385
386 F. Denoyelle et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 382–387

Table 2
Air conduction pure tone average and speech reception thresholds without Alpha-1 (pre-implantation) and with Alpha1 at month 6.

Without Alpha1 pre implantation With Alpha1 at M6 Mean gain p Value

ACPTA Mean  SD 69.02  9.31 33.49  4.89 35.53 <0.0001

Range (min–max) 50.9–81.9 25–41.7

SRT Mean  SD 71.73  9.20 38.27  4.54 33.47 <0.0001

Range (min–max) 57–90 30–44

Mean air conduction PTA and thresholds with 50% intelligibility (SRT) without Alpha1 (before implantation) and with Alpha 1 6 months after implantation. Free field testing
with contralateral masking; Results are given in dB; SD: standard deviation; min: minimum; max: maximum; ACPTA: air conduction pure tone average; SRT: speech
reception thresholds; M6: 6 months after implantation.

Table 3
Speech-in-noise tests without Alpha1 (pre-implantation) and with Alpha1 at month 6.

Without Alpha1 pre implantation With Alpha1 at M6 Gain: mean  SD p Value

SRT Mean  SD 59.20  10.46 51.40  10.99 7.80  4.11 <0.001

Range (min–max) 36–75 24–65

Speech-in-noise tests without Alpha1 (pre-implantation) and with Alpha1 at month 6, in real-life condition i.e. free field testing without masking and with the hearing device
on the contralateral ear if existing before surgery. Results are given in dB. SD: standard deviation; min: minimum; max: maximum; SRT: speech reception thresholds; M6:
6 months after implantation.

At M6, children answered to the satisfaction questionnaire (see satisfaction with a 12 to 32 months follow-up of the Sophono
annex 1): ‘‘satisfied’’ 6/15, ‘‘very satisfied’’ 8/15 or ‘‘no opinion’’ 1/1. Alpha1 device used for unilateral hearing rehabilitation. The non-
Parents answered satisfied 6/15 and very satisfied 9/15. inferiority trial demonstrates that the Sophono Alpha1 system is at
The last assessment was performed 12 to 32 months after least as effective as the reference closed skin device at the
surgery, median 19 months: two children stopped wearing the beginning of the study, the Softband BAHA1. However we did not
device 13 and 15 months after surgery, one for unclear reasons compare Sophono to percutaneous bone conduction devices.
(perhaps for cosmetic reasons in a teenager) and the second one One of the benefits of this percutaneous implant is the
because of social problems. The 13 other children were using their simplicity of the surgical procedure whatever the age of the child:
device 5–12 h a day, median 9 h. We found no correlation between the 2 mm deep bone beds do not need to expose the dura and
the duration of wearing, and either the ACPTA of the implanted ear, placement is easy. The first adaptation of the external processor
or the ACPTA of the contralateral ear, nor the aided ACPTA. could be conducted early, one month after the procedure, in all the
The first two patients displayed a slight erythema of the skin patients as scheduled.
covering the implant, wearing of the device was discontinued and The skin tolerance was one of the main concern with this new
the intensity of the external magnets reduced. The following magnetized implant. We did not use classifications used to
patients used magnets no. 1 or no. 0, and progressively increased evaluate the status of the skin around abutments as it was not
the duration of wearing and if necessary the intensity of suitable for transcutaneous devices. Our first two patients
magnetization. None of the 13 next patients experienced such experienced temporary skin erythema caused by the pressure of
skin erythema. At the last assessment, the skin facing the magnets the external magnet, which needed to interrupt the wearing of the
had a normal coloration in 8/13 children, and a pink coloration in 5/ device one week and to reduce the intensity of magnetization. In
13, with depilation in 2 cases (Fig. 2). 3/13 described brief episodes the following patients, this problem was avoided by creating a ‘‘0’’
of pain or tingling, needing to remove the device a few minutes to intensity for the youngest children, starting with the weakest
one day (Table 1). magnet (intensity 0 or 1) and progressively increasing the duration
of wearing: 2 h a day the first week, 6 h a day the second, and
Discussion permanent wearing the third week. In case of change of the
intensity of magnetization, the same protocol was used again.
In this prospective study, we evaluate the auditory benefit, 3 Children described brief episodes of pain or tingling, but so far,
cutaneous tolerance, quality of life and children and parents with a mean follow-up of 19 months (range 12–32) we did not
observe granulomas, extrusion or long term cutaneous complica-
tions. However, 2 skin breakdown out of 14 cases have been
Table 4
Non inferiority clinical trial. reported by O’Niel et al. [8] with a overall skin complication rate of
35.7%. We think that the graduated wearing schedule is a key point
Air conduction in tonal Values at Difference
to decrease the risk of skin complications.
audiometry (dB) each time
Concerning the two children who stopped wearing the device
Test-band BAHA, before surgery 13 and 15 months after surgery without clear reasons, it is difficult
n (missing values) 15 (0)
Mean  standard-deviation 32.89  5.86
to determine predictors of non-usage in small series: one point is
Median (Q1–Q3) 32.22 (26.67–38.33) that both non users had normal hearing on the contralateral ear. In
Minimum, maximum 25.0, 44.4 the series of 27 children fitted with percutaneous BAHA reported
Sophono Alpha1, after 6 months
by Priwin [10], 8 were non-users. The non user rate is not
n (missing values) 15 (0) frequently reported in the literature. In our series, children with
Mean  standard-deviation 33.49  4.89 0.60  6.91 unilateral hearing loss experienced the bone conduction device on
95% Confidence interval 3.22, 4.42 a test-band only, due to the organizational difficulties to lend to
Median (Q1–Q3) 33.33 (29.44–37.22) 0.56 (-5.56–3.89)
child a softband bone conduction device for a few weeks or months
Minimum, maximum 25.0, 41.7 11.7, 16.7
before implantation. This should be done before to decide the
 F. Denoyelle et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 382–387
rehabilitation, specifically in children with normal contralateral
hearing. However, the 2 non users have worn their device more
than one year. Perhaps a prolonged BAHA test-band trial would not
have changed their future decision.
The non-inferiority study was conducted by comparison of
the aided thresholds with Sophono Alpha1 to the thresholds
obtained with a BAHA1 device on a test-band in a same
patient. One bias is a possible overestimation of what would be
obtained with a Softband BAHA1 in real life: indeed, the aided
threshold obtained during the test (in this study 28 dB) is
probably better than what were obtained with a daily use of a
Softband: the Softband cannot be worn too tight and the
thresholds obtained are in general between 30 and 40 dB in
children. However, this demonstration had never been done
and seemed necessary.
It has been suggested that transcutaneous bone conduction
devices may suffer from attenuation induced by the skin, models
predicting a 10–15 dB loss using transcutaneous compared to
percutaneous devices; these transcutaneous data has been
obtained with devices maintained by a softband and not with
a magnetized device. The study of Hol [11] in children with ear
atresia is the only one comparing, the aided ACPTA thresholds
and aided SRT with Sophono Alpha1 to those obtained with a
BAHA1 on abutment (6 children in each group): the aided
ACPTA threshold was 3 dB better (33 vs. 36 dB) and the aided
SRT 7 dB better (23 vs. 30 dB) with the percutaneous BAHA1.
The auditory results reported here with Sophono Alpha1 in a
very similar population (high grade ear atresia) are within the
same range, with a mean aided ACPTA of 33.49–36.43 dB (at
month 6 and 12), and a mean aided SRT of 38.27 and 39 dB (at
month 6 and 12). We did not compare in the present study
Sophono to percutaneous bone conduction devices. However,
the aided threshold seems to be between what can be obtained
with a bone conduction system on a softband and with a
percutaneous bone conduction systems.
In this study we observed a 2.94 dB increase of the aided ACPTA
at M12 compared to M6: this progression is due to the adjustment
of the controls of the hearing aid in 2 children (no. 6 and no. 7) who
complained about feedback and with the adjustment of the anti-
feedback system, the ACPTA at 4 kHz decreased from 30 to 60 and
45 to 60, respectively. The mean SRT remained unchanged.
Conclusion
Advantages and disadvantages of the Sophono Alpha1 trans-
cutaneous hearing device can be summarized as follows: the
surgical procedure is easy and bone thickness has been always
sufficient for drilling the bone beds of the implant even in severely
malformed ears; the post-operative outcome is non-problematic
with a fast fitting of the device and with the possibility for a young
child to immediately place its external device itself; no cutaneous
complications have been observed in our 15 patients: these
3 points are a clear advantage especially in young children. In the
light of this study and of the previously published series, the aided
threshold is between the aided threshold with bone conduction
systems on a softband and with percutaneous bone conduction
systems. In conclusion the Sophono Alpha implant should be part
of the therapeutic hearing solutions proposed for the rehabilitation
of children with ear atresia.
387
Authors’ contributions
Françoise Denoyelle conceptualized and designed the study,
coordinated data collection, carried out the initial analyses, drafted
the initial manuscript and revised the manuscript. She had full
access to all of the data in the study and takes responsibility for the
integrity of the data and the accuracy of the data analysis.
Cyrille Coudert conceptualized and designed the study,
coordinated data collection, carried out the initial analyses and
critically reviewed the manuscript.
Briac Thierry, Marine Parodi, and Olivia Mazzaschi coordinated
data collection, carried out the initial analyses, and critically
reviewed the manuscript.
Eric Vicaut and Natacha Tessier conceptualized and designed
the study, carried out the statistical analyses, and critically
reviewed the manuscript.
Natalie Loundon and Noel Garabedian conceptualized and
designed the study and critically reviewed the manuscript.
All authors approved the final manuscript as submitted and
agree to be accountable for all aspects of the work.
Disclosure
None of the authors have conflict of interest for this study,
including relevant financial interests, activities, relationships, and
affiliations. The 15 Alpha1 implants have been provided by Collin
Medical Inc, Bagneux, France, distributor of the Sophono Alpha1
Implant.
Acknowledgments
The authors thank the children and families for their participa-
tion to the study and Nicolas Leboulanger for his information,
comments and corrections.
References
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aural atresia, Int. J. Pediatr. Otorhinolaryngol. 72 (10) (2008) 1455–1459.
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