A new adhesive bone conduction hearing system effectively treats conductive hearing loss in children

Accepted Manuscript A new adhesive bone conduction hearing system effectively treats conductive hearing loss in children Katrin Neumann, Jan Peter Thomas, Christiane Völter, Stefan Dazert PII:

S0165-5876(19)30135-1

DOI:

https://doi.org/10.1016/j.ijporl.2019.03.014

Reference:

PEDOT 9428

To appear in:

International Journal of Pediatric Otorhinolaryngology

Received Date: 20 October 2018 Revised Date:

1 March 2019

Accepted Date: 9 March 2019

Please cite this article as: K. Neumann, J.P. Thomas, C. Völter, S. Dazert, A new adhesive bone conduction hearing system effectively treats conductive hearing loss in children, International Journal of Pediatric Otorhinolaryngology, https://doi.org/10.1016/j.ijporl.2019.03.014. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT

A new adhesive bone conduction hearing system effectively treats conductive hearing loss in children

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Katrin Neumanna,b, Jan Peter Thomasb, Christiane Völterb,c, Stefan Dazertb

Division of Phoniatrics and Pediatric Audiology, cCochlear Implant Center, bDepartment of

Otorhinolaryngology, Head and Neck Surgery, St. Elisabeth-Hospital, Ruhr University Bochum,

Corresponding author: Prof. Katrin Neumann, M.D.

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Bochum, Germany

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Division of Phoniatrics and Pediatric Audiology

Department of Otorhinolaryngology, Head and Neck Surgery St. Elisabeth-Hospital, Ruhr University Bochum Bleichstr. 16

Germany

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44787 Bochum

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Phone +49 234 5098 470 Fax +49 234 5098 393

Mobile +49 160 9770 5590

E-mail: [email protected] Declarations of interest: The ADHEAR study devices were provided by the manufacturer (MEDEL, Innsbruck, Austria). All authors received travel and congress support by MED-EL for workshop participation and congress presentations. KN and SD received grant and research support for projects performed with MED-EL. SD and JPT got lecturers’ and speakers’ honorarium.

ACCEPTED MANUSCRIPT Adhesive bone conduction system for children

A new adhesive bone conduction hearing system effectively treats conductive hearing loss in children

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Katrin Neumanna,b,c, Jan Peter Thomasb, Christiane Völterb,c, Stefan Dazertb

Division of Phoniatrics and Pediatric Audiology, cCochlear Implant Center, bDepartment of

Otorhinolaryngology, Head and Neck Surgery, St. Elisabeth-Hospital, Ruhr University Bochum,

Corresponding author: Prof. Katrin Neumann, M.D.

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Bochum, Germany

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Division of Phoniatrics and Pediatric Audiology

Department of Otorhinolaryngology, Head and Neck Surgery St. Elisabeth-Hospital, Ruhr University Bochum Bleichstr. 16

Germany

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44787 Bochum

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Phone +49 234 5098 470 Fax +49 234 5098 393

Mobile +49 160 9770 5590

E-mail: [email protected] Declarations of interest: The ADHEAR study devices were provided by the manufacturer (MEDEL, Innsbruck, Austria). All authors received travel and congress support by MED-EL for workshop participation and congress presentations. KN and SD received grant and research support for projects performed with MED-EL. SD and JPT got lecturers’ and speakers’ honorarium.

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Abstract Objectives: Bone conduction hearing devices integrated in softbands (BCDSs) are frequently not

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well accepted by children with conductive hearing loss due to pressure on the head, sweating, or cosmetic stigma. A non-surgical hearing system (ADHEAR) uses a new bone conduction concept consisting of an audio processor connected to an adhesive adapter fixed behind the ear. This study is the first to evaluate the audiological and clinical outcome of this novel system,

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comparing it with conventional BCDSs in a short- and mid-term follow-up in children under 10

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years of age.

Methods: The ADHEAR was compared to a BCDS in 10 children with conductive hearing loss (age: 0.7 to 9.7 years). Aided and unaided pure tone/behavioral observational audiometry and, if applicable, speech audiometry in quiet and noise were performed initially with both devices and after 8 weeks with the ADHEAR alone. The subjective hearing gain and usage of the new hearing

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system, as well as patients’ and parents’ satisfaction were assessed using questionnaires. Results: The functional gain with the ADHEAR averaged over 0.5, 1, 2, and 4 kHz exceeded that

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of the conventional BCDS (35.6 dB ± 15.1 vs. 29.9 dB ± 14.6, p = .001, n = 9 ears). Speech perception in quiet and noise (n = 8) improved in the aided situation similarly for both hearing

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devices. The parents of 8 of 10 children evaluated the ADHEAR system as being useful. Minor wearing problems occurred occasionally. Eight children continued using the ADHEAR after the study, one received an active middle ear implant and one continued to use a BCDS. Conclusion: The ADHEAR system is a promising solution for children with conductive hearing loss or chronically draining ears. Keywords: conductive hearing loss; aural atresia, hearing aid; children; adhesive; bone conduction 2

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Introduction Permanent or long-lasting conductive hearing loss (CHL) in children, either congenital or

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acquired, may result from aural atresia, middle ear malformations, chronic otitis media with or without effusion, otosclerosis, or an adhesive process [1]. If untreated, the underlying mild to moderate hearing loss may impair a child´s language development with negative consequences for her or his verbal communication skills, social and emotional development, academic progress,

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and may also impact the whole family [2, 3]. Even untreated unilateral hearing loss, as in case of

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unilateral aural atresia, has been shown to have an impact on speech and language development and school success due to the child’s impaired speech understanding in noisy situations and sound localization [4, 5]. Hence, there is no doubt that permanent uni- or bilateral hearing loss in children needs to be treated.

Poor sound transmission to the inner ear can be treated non-surgically by conventional bone

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conduction (BC) hearing aids integrated in an elastic softband or fixed on a steel-spring headband or glasses. There are, however, well-known shortcomings associated with these BC devices

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(BCD), such as discomfort and poor aesthetics, which keep children and adults from wearing them. The major drawback is related to the constant static pressure force on the skin and skull of

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the wearer [6, 7]. Users often complain about sweating under the band or poor sound quality, as well as stigmatization due to its low aesthetic appeal [8]. Further disadvantages include damping of sound transmission due to hair between the contact plate and skin and unreliable positioning of the transducer if it slips from its place [9, 10]. The weaknesses of non-implantable BCDs such as steel-spring headbands, elastic headbands, or spectacles are overcome by bone conduction implants (BCIs) [11]. However, the invasive nature and the accompanying risks such as potential safety limitations due to preoperative 3

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computer tomography in children [12, 13] as well as current age restrictions (off-label use only below the age of 5 yrs.) and anatomical limitations make these surgical solutions not always ideal [14, 15].

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Recently, a new non-surgical BCD, the ADHEAR (MED-EL, Innsbruck, Austria), has been developed by P. Westerkull (Otorix AB, Askim, Sweden), based on a completely new concept of adhesive bone conduction [16]. The system consists of two components: a disposable adhesive

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adapter and a bone conduction audio processor (ADHEAR AP). The adhesive adapter is a

specially designed, non-toxic, non-allergic single use bandage, which consists of a triangular, soft

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rubber pad with a rigid center plate that is positioned on the hair-free zone over the mastoid. The adhesive attachment of the adapter on the skin behind the auricle ensures that it does not shift and provides a reliable connection between the contact plate and the skin. The adhesive adapter is water resistant, can be worn day and night, and may remain on the

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skin for several days. The audio processor is clipped onto the plastic snap-connector of the adhesive adapter and can be connected and disconnected without removing the adhesive adapter (Figure 1). The ADHEAR AP contains dual microphones and signal processing technologies. A

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push button on the device allows users to switch between four predefined programs. The volume can be adjusted with a small wheel on the side of the AP. It also provides direct audio input and

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the possibility to connect to remote wireless microphone systems.

Figure 1 about here

The indications for this system are patients with uni- or bilateral CHL or single sided deafness (SSD), without any age limitations.

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The ADHEAR hearing system was developed to overcome the drawbacks of conventional non-implantable bone conduction devices. Expected benefits include a reliable and pressure-free placement of the transducer and a less visible profile to improve comfort and aesthetics and to

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reduce the risk of stigmatization while ensuring sufficient audiological performance. The pressure-free yet sufficient transmission of vibrations to the inner ear is achieved by a lower mass of the skin-contact plate (adhesive adapter) and its greater proximity to the cochlea compared to

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conventional BCDSs [16].

To the best of our knowledge, no data on the performance and transmission concept of this

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new system have been published for children to date. A publication by Dahm et al. [16] includes adolescents and McDermott et al. [18] presented preliminary results from 4 to 14-year-old children on conferences, but there was no published data from this study available to the time of submission of this manuscript.

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To close the gap, this study aimed to evaluate the clinical efficacy of and the subjective satisfaction with the ADHEAR hearing system in children with conductive hearing loss aged below 10 years. Another goal was to compare the audiological performance of this new

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technology with that of conventional soft-band integrated bone conduction devices in this age

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group.

Material and methods Participants

All participants were recruited as a clinic-based sample and included in the study if they were (a) aged between 3 months and 10 years, (b) suffering from unilateral or bilateral permanent stable CHL that required treatment, and (c) able to undergo audiological testing. Exclusion criteria were 5

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a sensorineural component of the hearing loss exceeding 25 dB HL, a central auditory disorder or anatomical, skin or wound conditions and any physical or psychoemotional disorders that would

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interfere with the ability to wear the ADHEAR system. Eleven participants (P1-P11) met all inclusion and exclusion criteria and were enrolled in this study. One patient (P8) had to be excluded later due to noncompliance to the protocol. A total of ten children with bi- (n = 1) or unilateral (n = 8) aural atresia, one of the latter combined with a

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malformed contralateral middle ear, or frequently discharging ears (n = 1), six male and four female (median age: 4.4 years, range 0.7 to 9.7 years), were included in the final analysis.Of the

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10 study subjects, eight had experience using a BCDS before study participation: two wore the BCDS regularly, while the remaining six children, as well as the additional child (P12), refused to wear a softband-integrated device or wore it only irregularly because of unpleasant pressure on the head (n = 4; one of them with pressure marks) or cosmetic stigmatization (n = 2). For the

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participants’ biographical data and previously used hearing aids see Table 1.

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Table 1 about here

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The results of an additional 3.8 year old boy (P12) are shown separately. He was not included in the study cohort because he was a multi-handicapped, non-speaking child with CHL solely in the low frequencies around 500 Hz. He suffers from a cilia dysfunction with airway obstructions, perforated ear drums persisting after ventilation tubes, chronically discharging ears, and a profound global developmental delay including intellectual disability due to a permutation in the FMR1 gene.

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This prospective study used a single-subject, repeated-measure design, in which each subject serves as its own control. The study was approved by the Ethics committee of the Medical Faculty of Ruhr University, Bochum (EK Number: 17-6062). All procedures applied were carried

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out in accordance with the Declaration of Helsinki. Informed consent was obtained from the parents and additionally from children 6 years or older prior to any study related procedure. Devices

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For all study-related tasks the ADHEAR system was used in the default mode (program number

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one) without any further fitting changes. The BCDS was either the participant’s own well-fitted device as specified in Table 1 or a BAHA5 (Cochlear Inc., Mölnlycke, Sweden) fitted to a BC threshold of 10 dB for all frequencies. The volume was adjusted to the patient’s preference for all tests.

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Experimental setup

Participants underwent audiological examination at two time points (T0 and T1). Initially (time point T0), after assessing their hearing thresholds for air and bone conduction, they underwent

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sound field audiometry with age-appropriate stimuli and, if applicable, speech in quiet and in noise (1) in the unaided and aided conditions with (2) the ADHEAR and (3) a BCDS. The order

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of examination of participants either first with the ADHEAR or the BCDS was randomized. To reduce the length of testing on the young children, the T0 test battery was occasionally divided into two sessions (visit 1 and visit 2). For patients with bilateral CHL, each ear was examined and reported separately. The number of participants examined per test varied depending on the age and the individual’s mental capability and concentration span. Furthermore, age-appropriate questionnaires on the hearing-related development and disability of the participants were administered to the parents. 7

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After completing the initial assessment at T0, parents were asked to let their children wear the ADHEAR system for 8 weeks and return for the final assessment at T1 (mid-term follow-up). At T1 the audiometric measurements were repeated with the ADHEAR. The parents were asked to

usage of the device and patients’ and parents’ satisfaction. Hearing thresholds

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fill in the questionnaire a second time, as well as the ADHEAR questionnaire that assesses the

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The audiometric tests for the unaided air conduction (AC) and bone conduction (BC) hearing

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thresholds were chosen according to the age and developmental status of the individual child. Either auditory brainstem responses (ABR) were recorded for both AC and BC using click stimuli and narrow-band CE chirp stimuli at 0.5, 1, 2, and 4 kHz, or pure-tone thresholds were measured by behavioral audiometry (BA) at 0.5, 1, 2, 4, and 8 kHz (AC) and at 0.5, 1, 2, and 4 kHz (BC) (see Table 1). Masking of the better hearing ear was performed using white noise

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during both BA and ABR. No masking was possible for P7 with bilateral aural atresia, however the medical history however the medical history together with the lacking discrepancy between

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both ears in the ABR recordings supports the diagnosis of a symmetric hearing loss. Sound field threshold audiometry

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In order to evaluate the functional gain with BC devices, sound field thresholds were assessed in aided and unaided conditions. Warble tones or narrow band noises were used as stimuli for children under four years of age and pulsed pure tones were used for older children. The measurements were conducted in quiet at 0.25, 0.5, 1, 2, 4, and 8 kHz with the child sitting 1 meter away from the loudspeakers. If the CHL was unilateral or asymmetric, the better hearing ear was occluded with an ear plug (3M Ear Plug 1100) and covered with an ear muff (3M Peltor

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X5A). This occlusion of the contralateral ear resulting in a masking of about 50 dB does not exclude a slight contribution of this ear to the sound field audiometric results.

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Speech audiometry in quiet and noise Speech audiometry in quiet and in noise, if applicable, was performed using German speech audiometric tests for children. Based on developmental age, either the German Mainzer

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Kindersprachtest (Mainz Child Speech Test; [19]), the Göttinger Kindersprachverständnistest (Goettingen Child Test for Speech Perception; [20, 21]), or the Freiburger Test für Einsilber und

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Zahlen (Freiburg Test for Monosyllables and Numbers; [22]) was used.

The sound field speech testing in quiet was conducted with the speaker at 0° azimuth (S0) and a distance of one meter from the center of the subject’s head at a speech level of 65 dB SPL. The speech audiometry in noise was tested with a fixed noise level of 60 dB SPL and a fixed speech level of 65 dB SPL, resulting in a signal-to-noise ratio of 5 dB SNR. Loudspeakers

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presented speech from the front and noise from the back (S0N180). For participants with unilateral or asymmetric CHL, the better hearing ear was plugged and covered as described above.

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Questionnaires

At T0 the parents were asked to fill in a questionnaire appropriate to the child’s age in order to

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record their child’s situation without a hearing device. The LittlEARS Auditory Questionnaire (LEAQ) was used for children up to 24 months of age. For older children the Speech, Spatial and Qualities of Hearing Scale Questionnaire for parents (SSQP) was administered. At T1 the ageappropriate questionnaire and an ADHEAR-specific questionnaire, provided by the manufacturer, recorded the experience with the ADHEAR system after the 8-week trial.

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The LEAQ is a module of the LittlEARS comprehensive test battery for children up to two years of age who have either normal hearing or wear cochlear implants or hearing aids [23]. It assesses the auditory development of young children and consists of 35 items with “yes” or “no”

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answers.

The Speech, Spatial and Qualities of Hearing Scale Questionnaire (SSQ) assesses several domains of hearing disabilities [24]. The questionnaire evaluates the perception of speech in a

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variety of spatial hearing situations. It also assesses the listener’s ability to segregate sounds and

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to attend to simultaneous speech streams as well as the listener’s quality of hearing such as the ease of listening and the naturalness, clarity, and identifiability of different speakers, musical pieces, instruments, and sounds of everyday life. The parents’ version (SSQP) [25] consists of 23 items, with answers rated on a Likert scale from 0 (not at all) to 10 (perfectly).

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Statistical analysis

For between-group comparisons, the Shapiro-Wilk normality test was used to determine if the data was normally distributed. For inferential statistics, the Student`s t-test was used as a

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parametric test and the Wilcoxon test as a non-parametric test, the latter in order to compare the data sets of the SSQP questionnaire. The Wilcoxon signed-rank test with a p-value adjustment

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using Bonferroni correction was performed to analyze the differences between the data sets of the unaided condition and the BCDS and ADHEAR conditions, respectively, and between both latter conditions. Statistical significance was defined as *p < .05 and **p < .001, resulting in an adjusted p value of *p < .017 and **p < .003, respectively. No statistical evaluation was done when the number of samples was equal to or smaller than five (n ≤ 5). GraphPad Prism 6 for Windows 2010 Version 6.02 was used for the analyses and for the graphs.

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Results Sound field thresholds

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Sound field thresholds comparing three conditions ― unaided, aided with BCDS, and aided with ADHEAR ― measured at T0 for the frequencies 0.25, 0.5, 1, 2, 4, and 8 kHz are depicted in Figure 2. Significant differences between the unaided and aided conditions, no matter which

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device was used, were obtained for the frequencies 0.25, 0.5, 1, 2 and 4 kHz. At 8 kHz, no

significant difference was observed when comparing the unaided condition at 67.1 dB HL ± 13.2

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to the aided thresholds of the BCDS at 50.7 dB HL ± 9.8 (p = .031), while the difference between the unaided condition and the aided one using the ADHEAR was significant (38.6 dB HL ± 8.5, p = .016). The mean functional gain (FG) averaged over the frequencies from 0.5 to 4 kHz was statistically higher (t-test, p = .001 / n = 9) for the ADHEAR (FG: 35.6 dB ± 15.1) than for the BCDS (FG: 29.9 dB ± 14.6). For all frequencies tested, the ADHEAR obtained better average

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results which reached significance at 1 and 8 kHz. The aided thresholds improved at 1 kHz from 41.8 dB HL ± 19.1 with the BCDS to 33.6 dB HL ± 14.5 with the ADHEAR (p = .012) and at 8

Figure 2 about here

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kHz from 50.7 dB HL ± 9.8 with the BCDS to 38.6 dB HL ± 8.5 with the ADHEAR (p = .016).

Mid-term, sound field thresholds with ADHEAR The mid-term hearing benefit with the ADHEAR at T1 is demonstrated in Figure 3, showing the sound field thresholds averaged over 0.5, 1, 2, and 4 kHz for the unaided and the ADHEARaided conditions at the initial assessment (T0 ADHEAR) and 8 weeks later (T1 ADHEAR). There was a significant improvement from 65.6 ± 13.7 dB HL unaided to an average aided 11

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threshold of 32.2 ± 11.6 dB HL (p = .004) at T0 and of 29.7 ± 8.3 dB HL (p =.004, n = 9) at T1, resulting in a functional gain of 33.3 ± 16.0 dB for the initial and of 35.8 ± 15.8 dB for the midterm ADHEAR usage as compared with the unaided situation. The improvement in the aided

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performance between T0 and T1 was not significant.

Speech understanding in quiet and noise

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Figure 3 about here

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During the initial assessment at T0, the word recognition score (WRS) at 65 dB SPL in quiet improved from a mean WRS of 13.8 ± 16.9% unaided, to 86.3 ± 9.2% (p = .008, n = 8) with the BCDS and 91.3 ± 11.3% (p = .008, n = 8) with the ADHEAR, resulting in average improvements of 72.5 ± 12.8% and of 77.5 ± 15.8%, respectively (Figure 4a).

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At T1 the mean WRS in quiet improved from 15.7 ± 17.2% unaided, to 90.0 ± 8.2% aided with the ADHEAR at T1 (p = .016, n = 7). The difference between T0 ADHEAR (91.4 ± 12.2%, n = 7) and T1 ADHEAR (90.0 ± 8.2%, n = 7) was not significant.

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For the initial speech understanding in noise examination, the mean WRS of 18.8 ± 22.3% in the

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unaided condition rose to 75.0 ± 16.9% with the BCDS (p = .008, n = 8) and to 77.5 ± 14.9% with the ADHEAR (p = .008, n = 8), resulting in mean improvements of 56.3 ± 22.6% and 58.8 ± 19.6%, respectively (Figure 4b). At T1 the mean WRS in noise improved from 4.0 ± 8.9% unaided, to 82.0 ± 19.2% at T1 ADHEAR (p = .063, n = 5). The difference between T0 ADHEAR (72.0 ± 14.8%, n = 5) and T1 ADHEAR (82.0 ± 19.2%, n = 5) was not significant.

Figures 4a and 4b about here 12

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Questionnaire outcomes The parents of the four children below the age of two completed the LEAQ for both the unaided

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and the ADHEAR-aided conditions. In the unaided condition the participants reached scores above the critical threshold for their age and two reached scores above the expected threshold for their age. The scores did not change significantly in the aided condition. On average the four

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children reached 20.0 ± 5.9 points unaided and 22.0 ± 2.9 points after 8 weeks of device usage. The parents of six children completed the SSQP. On a scale of one to ten, the average total

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score improved by 2.9 ± 2.7 points from an average of 4.4 ± 3.1 points unaided to 7.3 ± 1.5 points after using the ADHEAR for 8 weeks. The improvement in the total score and in the categories speech, spatial hearing, and qualities of hearing were 2.9 (p = .0313), 3.0 (p = .0313), 2.6 (p = .0625), and 3.0 (p = .0313), respectively (Figure 5). For three children with unilateral CHL high unaided SSQP total scores of 5.0, 8.6, and 7.3 were obtained. Unsurprisingly, their

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parents experienced only minor improvements of 1.1, 0.8, and 0.5 SSQP total score points. The other three children, including two with bilateral hearing loss, improved by 2.8, 4.9, and 7.2

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points.

The ADHEAR-specific questionnaire was completed for ten children (Figure 6). Half of them used the ADHEAR system for more than eight hours per day (average: 7 ± 4.4 hours, n = 10). The average wearing time until the adhesive adapter had to be changed was 2.7 days (range: 1 to 7 days). Most of the time only one attempt was necessary to place the adhesive adapter behind the ear. Two users often needed more than one attempt to place the audio processor onto 13

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the adhesive adapter, one user required help from a second person, and the remaining seven usually needed one attempt. Wearing the adhesive adapter seemed to annoy two children, four appeared as noticing its presence without feeling disturbed, and four children forgot about it some

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or most of the time. The majority rated the ADHEAR system as valuable (n = 3) or very valuable (n = 5). The parents of two children evaluated the system as not being valuable.

Five users reported no skin irritation, while some redness (answer: yes, a little) was noted in

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four participants. In three of the four participants, this skin reaction did not affect daily adhesive adapter usage, but one child (P3) discontinued usage of the ADHEAR and received a Vibrant

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Soundbridge (MED-EL, Innsbruck, Austria) instead. For another child (P6), the answer “very bothersome” was selected, and the child went back to using her BCDS. Nevertheless, the parents of both children rated the ADHEAR system as a very valuable aid.

Half (n = 5) of the parents reported that their child spoke more clearly when using the

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ADHEAR, that the sound quality was good (n = 3) or very good (n = 3) and that other people would rarely (n = 3) or even hardly ever (n = 3) notice that the child was wearing a hearing

Figure 6 about here

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device.

Additional child

The non-speaking 3.8 year old syndromic child (P12) had an ABG of about 30 dB at 0.5 kHz, with normal ABR AC thresholds of about 10 dB nHL at 1, 2, and 4 kHz. Although the boy had not tolerated a BCDS, he accepted bilateral ADHEARs, seemed not to even notice them, and wore them all day. The adhesive adapters were changed every second day and the parents 14

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reported that the boy became much calmer and more attentive when wearing the devices and stopped acoustically stimulating himself by producing loud noises. After 4 months of use, the boy

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started to produce his first words at an age of 4.2 years. Discussion

In this study, we have shown that the novel bone conduction system ADHEAR significantly

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improved the functional hearing gain and speech perception in quiet and noise in pediatric

patients with conductive hearing loss due to aural atresia or chronic otitis media with discharging

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ears. The improvements were comparable to those achieved with conventional bone conduction devices on softbands. Although eight out of the ten subjects had previously worn BCDSs, some even exceeded functional hearing gain scores at the first fitting with the ADHEAR and these scores remained stable over a follow-up period of eight weeks.

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The results of this study are in line with recently published data of adults and adolescents [26] wearing adhesive and softband-attached systems. The results are also in accordance with the congress report by McDermott et al. [18] on 20 children aged 4 to 14 years and fitted with the

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ADHEAR’s predecessor, the Adjoin. Their audiological results were comparable to or better than those with a BCDS. Half of the children kept on wearing the Adjoin instead of switching to a

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BCDS.

Our study is the first on this device that includes children younger than 4 years, with four participants less than 1 year old. Because parents of children with ear atresia or other ear malformations usually consult a specialist when their child is a baby, it is desirable for professionals to have a treatment-solution for this age group, particularly for children with bilateral CHL. Our study indicates that the ADHEAR may be a good option in these cases.

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Eight patients had been fitted with BCDSs prior to receiving an ADHEAR, but only two had worn them without problems. The six remaining children did not accept their devices well due to stigmatization, inconvenience, or pressure on the head, one baby (P11) even with pressure marks.

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Because children with unilateral CHL have one normal-hearing ear, they often do not accept a BCDS as the drawbacks exceed the subjective listening improvement; however, the ADHEAR was widely accepted by this patient group.

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After completion of the study, nine out of eleven participants (including the additional child)

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continued to use the ADHEAR. The remaining two had an adverse skin reaction and either received an active middle ear implant (P3) or continued to use a BCDS (P6). The parents of P7 initially reported acoustic feedback when their child leaned against car seats or sofa backs and about his difficulty wearing caps. After initial re-use of two BCDSs, they returned to ADHEARs one year later, having been advised about better handling and noticing a better hearing of their

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child with ADHEARs than with BCDSs. The parents of P9 initially returned to a BCDS because their baby often manipulated at the ADHEAR and seemed to be disturbed by feedback sounds. After their child was about 1 year old, they were not satisfied with the BCDS and returned to

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ADHEAR, which is now accepted by the child.

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When interpreting our results, the higher test-retest variability seen in pediatric audiology than in adults has to be taken into consideration [27]. Care was taken to perform the tests under the best pediatric audiological conditions, and therefore the T0 assessment was split into two sessions if necessary. It is worth noting that despite the fact that eight out of the ten children have had previous experience with a BCDS, the subjects attained numerically better average results with the ADHEAR than with the BCDS on all 8 tests (sound field thresholds at six frequencies and speech in quiet and noise at T0). 16

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Compared to the BCDS the participants achieved significant improvements with the ADHEAR in the sound field thresholds at 1 kHz and 8 kHz immediately after the first attachment, without acclimatization time. The superior performance observed with the ADHEAR

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in the high frequencies was an expected effect due to improved energy transmission with the adhesive system in this frequency range. It may be explained by the lower mass of the contact plate (adhesive adapter) of the system, its closer connection to the head without hair between the

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contact plate and skin, and the beneficial position of the ADHEAR closer to the cochlea than a BCDS [28]. Furthermore, the ADHEAR’s vibrational portion was especially designed for

a feature not seen in BCDs [16].

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adhesive bone conduction and provides a product-specific second resonance boost at 6 to 8 kHz,

In our study significant differences in the functional gain between BCDS and ADHEAR were observed. These results contrast with those of the Dahm et al. study [17], where no significant

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differences were found. But unlike in our study, Dahm and colleagues did not randomize their test sequence of both devices and always tested the BCDS after the ADHEAR.

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According to the classification of general word recognition ability [29], the children in our study using the ADHEAR achieved a mean word recognition score within normal limits (91%) in quiet

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and with only slight difficulties (78%) in noise. Slightly but not significantly worse results were obtained with the BCDS, i.e. slight difficulties in quiet (86%) and moderate difficulties (75%) in noise. The results obtained with the BCDS are comparable to those published by Wang for children [30]. Conversely, Dahm et al. [17] reported poorer word recognition scores with the ADHEAR, in their study the majority of patients had undergone a mastoidectomy with canal wall down procedure, most probably impairing the energy transmission for bone conduction. Furthermore, three out of twelve patients had BC thresholds at the upper limit or presumably 17

ACCEPTED MANUSCRIPT Adhesive bone conduction system for children

above the ADHEAR indication thresholds (≤ 25 dB HL BC-threshold between 0.5 and 4 kHz). Hence, this study sample shows limited comparability with ours. In another study, the ADHEAR, a BCDS, and a passive transcutaneous system revealed comparable results for speech perception

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in quiet and noise [31].

In two cases, local skin irritations with redness and vesicles beyond the adhesive region prevented the children from continuing to use of the ADHEAR. No redness occurred when an

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adhesive adapter was applied to a different skin position (recommended by investigators) in these

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children. Hence, allergic reactions were ruled out. To protect the skin from irritation, a barrier film cream (e.g. Cavilon, 3M) can be used before applying the adhesive adapter. Skin complications can also occur in child BCDS users due to the pressure on their head [7]. A study by Verhagen et al. [32] reported pressure marks using BCDs on head- or softbands in 50% of the children. In our study, P11 could not wear a BCDS due to pressure marks.

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Adapter adhesion was sufficient for most of the subjects in our study but varied between one and seven days among participants. Excessive handling of the adapter or rubbing against car seats, armrests, hats etc. as well as variations in mastoid shape, skin type, sweating, or a

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combination of these factors could cause the observed differences. Infants younger than one year

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may need more frequent adapter changes than older children, probably because the stratum corneum of the skin of babies is significantly more hydrated than the adult skin [33]. Extensive ear malformations are sometimes associated with an enlarged or abnormally shaped hair-free zone which offers the opportunity to place the adhesive adapter in alternative positions, as in the case of participant P11. Future developments of the device might create individualized treatment solutions aimed at providing alternative adhesive materials and shapes adapted to the patient's needs. 18

ACCEPTED MANUSCRIPT Adhesive bone conduction system for children

Both participants with multiple and intellectual disabilities (P1, P12) accepted the ADHEAR well and showed a benefit. Probably the lack of pressure on the head makes these children forget the device and makes it promising for intellectually and multiply handicapped children with

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CHL.

Longitudinal studies are needed to determine whether the ADHEAR is a suitable device to provide acoustic stimulation to infants with uni- and bilateral permanent CHL, including

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chronical ear secretion. Children with SSD could also benefit from the adhesive system [34] and

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be a target group for further studies. Conclusion

This study provides evidence that the new adhesive bone conduction concept of transferring vibrations via a no-pressure adhesive adapter to the head, together with the ADHEAR audio

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processor, is an effective treatment method in children with conductive hearing loss resulting from congenital aural atresia, other ear malformations, or chronically discharging ears. The audiological performance with the ADHEAR was comparable to or even slightly better than that

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obtained with a conventional softband-integrated bone conduction system. Patients and parents both demonstrated high levels of satisfaction with the device, especially in relation to the fact that

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it overcomes many of the pressure-related limitations of softband-integrated bone conduction systems and because the device is cosmetically appealing with no or only minor stigmatization. Most patients continued to use the adhesive device after the end of the study. Because of these advantages, the ADHEAR system seems to be a valuable treatment option for children with the above-mentioned conditions, although the conventional BCDS remains a suitable alternative for patients who cannot wear the adhesive for various reasons. The shortcomings observed in this study should be addressed by further technical improvements. 19

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Studies with larger samples and a longer follow-up period are necessary to corroborate the data found in this research and to track the children’s speech development over time. Acknowledgement

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The authors wish to thank the parents of the children included in the study and Silke Hegenberg,

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Claudia Toffel, and Angelika Springer for assessing the audiometric data.

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Table 1. Biographical and medical data of study participants. Air conduction (AC) and bone conduction (BC) hearing thresholds are calculated as average results of the frequencies at 0.5, 1, 2 and 4 kHz. Air-bone gaps (ABG) of about 60 dB result from slight inaccuracies in the children’s

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behavioral audiometric responses compared with responses of adults (P05, P06) or from the known phenomena of slightly higher potential thresholds than derived audiograms in ABR (auditory brainstem response) recordings (P7), in particular in the low frequency region. Normal or near to normal BC thresholds and normal ABR inter-peak latencies ensured the absence of a relevant perceptive hearing loss component for all

P3

f

m

9.7

Down syndrome, chronic otitis media with recurrently discharging ears

8.8

hemifacial macrosomia, congenital ear atresia

0.8

congenital ear atresia

P4

m

3.8

congenital aural atresia, intrauterine growth retardation, former preterm infant

P5

m

7.2

congenital aural

Uni-/ bilateral CHL

Hearing thresholds

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Aetiology

Previously aided

Difficulties with previous devices

Further treatment

bi

right: AC 45 dB HL, BC 8 dB HL, ABG 38 dB left: AC 61 dB HL, BC 8 dB HL, ABG 54 dB assessed by BA1

uni

left: AC 65 dB HL, BC 8 dB HL, ABG 58 dB assessed by BA

BCDS (BAHA 4)

BCDS at school age no longer accepted due to aesthetic stigmatization

no surgery wished; use of ADHEAR continued, hidden under the hair, no stigmatization

uni

right: AC 68 dB nHL, BC 10 dB nHL, ABG 58 dB assessed by ABR4

no

n.a.

uses active middle ear implant (Vibrant Soundbridge); ADHEAR refused due to skin irritation

uni

right: AC 73 dB HL, BC 19 dB HL, ABG 54 dB assessed by BA

BCDS (BAHA 4)

BCDS not well accepted and rarely worn

no surgery wished; surgical options restricted due mastoid and middle ear malformation; use of ADHEAR continued

uni

right: AC 70 dB HL, BC 9 dB HL, ABG

BCDS

BCDS not accepted due to

no surgery wished; use of ADHEAR

ACD2 BCDS (la belle BC 811 junior)

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P2

f

Age (yrs.)

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P1

Sex

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Num ber

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children.

ACD: recurrently discharging ear BCDS: not accepted

no surgery wished, only medical treatment of ear secretion; use of ADHEAR continued

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P9

P 10

m

m

m

P 11

f

P 12 additio nal

m

4.9

congenital aural atresia

2.5

congenital aural atresia

0.7

0.7

congenital aural atresia

congenital aural atresia

0.7

congenital aural atresia right; middle ear malformation left

3.8

ciliopathy, permutation in FMR1 gene, intellectual

bi

right: AC 60 dB nHL, BC 0 dB nHL, ABG 60 dB left: AC 60 dB nHL, BC 0 dB nHL, ABG 60 dB assessed by ABR

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uni

continued

especially at school

BCDS regularly worn, despite sensed aesthetic stigmatization

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congenital aural atresia

BCDS (la belle BC 811 junior, contact mini)

esthetic stigmatization,

BCDS (contact mini)

BCDS regularly worn without problems, but better aesthetic appeal desired by parents

no surgery wished; ADHEAR refused due to skin irritation; use of BCDS continued

no surgery wished; ADHEAR initially refused due to feedback and hat wearing problems and use of BCDS continued; 1 after 1 year re-use of ADHEAR due to better hearing

n.a.

excluded from analysis because of poor adherence to study protocol; transcutaneous hearing implant planned

No

n.a.

ADHEAR initially refused due to feedback and handling problems and BCDS kept, some months later continued re-use of ADHEAR

left: AC 55 dB nHL, BC 10 dB nHL, ABG 45 dB assessed by ABR

BCDS (BAHA 4)

BCDS not well accepted

bi

right: AC 75 dB nHL, BC 20 dB nHL, ABG 55 dB left: AC 73 dB nHL, BC 20 dB nHL, ABG 53 dB assessed by ABR

BCDS right (la belle BC 811 junior) ACD left

BCDS pressure marks on the head ACD initially not well accepted

bi

at 500 kHz right and left AC 50 dB nHL, BC 10 dB nHL, at 1,

BCDS (BAHA 5 power)

BCDS not accepted

uni

no results

uni

right: AC 65 dB nHL, BC 20 dB nHL, ABG 45 dB assessed by ABR

uni

No

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P8 exclud ed

m

6.9

right: AC 69 dB HL, BC 9 dB HL, ABG 60 dB assessed by BA

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P7

f

(BAHA 4)

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P6

61 dB assessed by BA

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atresia

no surgery planned use of ADHEAR continued

no surgery planned use of ADHEAR continued

use of ADHEAR continued

22

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Adhesive bone conduction system for children disability, nonspeaking, bilateral ear drum perforations, chronically discharging ears

2, 4 kHz right and left AC 10 dB nHL, BC 10 dB nHL assessed by ABR

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child

BA: behavioral audiometry, 2ACD: air conduction device,

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1

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Figure 1. ADHEAR bone conduction system worn by an 8-month old baby (with kind permission of the parents): (a) adhesive adapter, (b) audio processor on adhesive adapter.

Figure 2. Box plots of frequency-specific sound field thresholds for unaided (white boxes) and aided with a BCDS (light grey boxes) or with ADHEAR (dark grey boxes) conditions at T0

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across the frequencies 0.25 kHz (n = 7), 0.5 kHz (n = 10), 1 kHz (n = 11), 2 kHz (n = 10), 4 kHz (n = 9), and 8 kHz (n = 7). Compared with the unaided condition, significant

improvement with the ADHEAR was obtained at frequencies 0.5 to 8 kHz and with the BCDS at 0.5 to 4 kHz, as indicated by asterisks. Significant improvement with the ADHEAR over

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the BCDS was attained at 1 and 8 kHz.

Figure 3. Box plots and individual data (open circles) of frequency-specific sound field

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thresholds averaged over 0.5, 1, 2, and 4 kHz for the unaided (white box) and the ADHEARaided conditions at the initial assessment (T0, light grey box) and 8 weeks later (T1, dark grey box) (n = 9). Asterisks indicate a significant improvement using the ADHEAR initially or in the mid-term, compared with the unaided condition. No significant (ns) improvement was observed between initial (T0) and mid-term (T1) usage.

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Figure 4: Box plots and individual data (open circles) of word recognition scores at the initial (T0) unaided (white boxes) and the aided with BCDS and ADHEAR conditions (light grey boxes) and with the ADHEAR after 8 weeks of use (T1, dark grey boxes) for (a) speech in quiet at 65 dB SPL (n = 8 at T0, n = 7 at T1) and (b) speech in noise, with the speech level at

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65 dB SPL and noise at 60 dB SPL (n = 8 at T0, n = 5 at T1). Asterisks indicate significant improvement with T0 ADHEAR or T0 BCDS compared with the unaided condition. There

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was no significant difference between matched samples of T0 ADHEAR and T1 ADHEAR in speech in quiet and speech in noise.

Figure 5. Box plots and individual data (open circles) of the parental evaluation of the SSQP domains speech, spatial hearing, and perceptive qualities of n = 6 children and the SSQP total scores for the unaided at T0 (white boxes) and aided with ADHEAR at T1 (grey boxes) conditions. Asterisks indicate significant improvement with the ADHEAR compared to the unaided condition.

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Figure 6. Parental experience with the ADHEAR system after 8 weeks of use by their child, evaluated with the ADHEAR questionnaire. The darker grey cells are colored, the more

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positive are the responses.

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References

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[1] W. Dougherty, B.W. Kesser, Management of Conductive Hearing Loss in Children, Otolaryngol Clin North Am, 6 (2015) 955-974. [2] M.P. Moeller, J.B. Tomblin, An Introduction to the Outcomes of Children with Hearing Loss Study, Ear Hear, (2015) 4-13. [3] J.B. Tomblin, M. Harrison, S.E. Ambrose, E.A. Walker, J.J. Oleson, M.P. Moeller, Language Outcomes in Young Children with Mild to Severe Hearing Loss, Ear Hear, (2015) 76-91. [4] J.E. Lieu, Management of Children with Unilateral Hearing Loss, Otolaryngol Clin North Am, 6 (2015) 1011-1026. [5] P. Vila, J.E.C. Lieu, Asymmetric and Unilateral Hearing Loss in Children, Cell and tissue research, 1 (2015) 271-278. [6] A.L. McDermott, S.N. Dutt, E. Tziambazis, A.P. Reid, D.W. Proops, Disability, handicap and benefit analysis with the bone-anchored hearing aid: the Glasgow hearing aid benefit and difference profiles, J Laryngol Otol Suppl, 28 (2002) 29-36. [7] M.K. Hol, C.W. Cremers, W. Coppens-Schellekens, A.F. Snik, The BAHA Softband. A new treatment for young children with bilateral congenital aural atresia, Int J Pediatr Otorhinolaryngol, 7 (2005) 973-980. [8] B.E. Hakansson, P.U. Carlsson, A. Tjellstrom, G. Liden, The bone-anchored hearing aid: principal design and audiometric results, Ear Nose Throat J, 9 (1994) 670-675. [9] B. Hakansson, A. Tjellstrom, U. Rosenhall, Hearing thresholds with direct bone conduction versus conventional bone conduction, Scand Audiol, 1 (1984) 3-13. [10] A.J. Zarowski, N. Verstraeten, T. Somers, D. Riff, E.F. Offeciers, Headbands, testbands and softbands in preoperative testing and application of bone-anchored devices in adults and children, Adv Otorhinolaryngol, (2011) 124-131. [11] J.P. Thomas, C. Voelter, K. Neumann, S. Dazert, Vibroplasty in Severe Congenital or Acquired Meatal Stenosis by Coupling an Active Middle Ear Implant to the Short Process of the Incus, Otol Neurotol, 7 (2017) 996-1004. [12] J.E. Adams, K. Engelke, B.S. Zemel, K.A. Ward, Quantitative computer tomography in children and adolescents: the 2013 ISCD Pediatric Official Positions, J Clin Densitom, 2 (2014) 258-274. [13] K.R. Kutanzi, A. Lumen, I. Koturbash, I.R. Miousse, Pediatric Exposures to Ionizing Radiation: Carcinogenic Considerations, Int J Environ Res Public Health, 11 (2016). [14] A. Hagr, BAHA: Bone-Anchored Hearing Aid, Int J Health Sci (Qassim), 2 (2007) 265-276. [15] S. Roman, R. Nicollas, J.M. Triglia, Practice guidelines for bone-anchored hearing aids in children, European Annals of Otorhinolaryngology, Head and Neck Diseases, 5 (2011) 253-258. [16] P. Westerkull, An Adhesive Bone Conduction System, Adhear, a new treatment option for conductive hearing losses, J Hear Sci, 2 (2018) 9. [17] V. Dahm, W.D. Baumgartner, R. Liepins, C. Arnoldner, D. Riss, First Results With a New, Pressurefree, Adhesive Bone Conduction Hearing Aid, Otol Neurotol, 6 (2018) 748-754. [18] A.L. McDermott, A. Child, J. Gill, The Adjoin adhesive adapter: new innovation in bone conduction hearing, 5th International Congress on Bone Conduction Hearing and Related Technologies, Lake Louise, Canada, 2015. [19] P. Biesalski, H. Leitner, E. Leitner, D. Gangel, [The Mainz audiometric speech test for children (author's transl)], Hno, 5 (1974) 160-161. [20] R. Chilla, P. Gabriel, P. Kozielski, D. Bansch, M. Kabas, [The Gottingen audiometric speech test for children. I. Speech audiometry of the young and retarded child by a picture-test (author's transl)], Hno, 10 (1976) 342-346.

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[21] P. Gabriel, R. Chilla, C. Kiese, M. Kabas, D. Bansch, [The Gottingen audiometric speech test for children. II. Speech audiometry of the pre-school child with a monosyllabic picture-test (author's transl)], Hno, 11 (1976) 399-402. [22] K.H. Hahlbrock, [Speech audiometry and new word-tests], Arch Ohren Nasen Kehlkopfheilkd, 5 (1953) 394-431. [23] B. May-Mederake, H. Kuehn, A. Vogel, A. Keilmann, A. Bohnert, S. Mueller, G. Witt, K. Neumann, C. Hey, A. Stroele, C. Streitberger, S. Carnio, P. Zorowka, D. Nekahm-Heis, B. Esser-Leyding, J. Brachmaier, F. Coninx, Evaluation of auditory development in infants and toddlers who received cochlear implants under the age of 24 months with the LittlEARS) Auditory Questionnaire, Int J Pediatr Otorhinolaryngol, 10 (2010) 1149-1155. [24] S. Gatehouse, W. Noble, The Speech, Spatial and Qualities of Hearing Scale (SSQ), Int J Audiol, 2 (2004) 85-99. [25] K.L. Galvin, W. Noble, Adaptation of the speech, spatial, and qualities of hearing scale for use with children, parents, and teachers, Cochlear Implants Int, 3 (2013) 135-141. [26] T. Gawliczek, F. Munzinger, L. Anschuetz, M. Caversaccio, M. Kompis, W. Wimmer, Unilateral and Bilateral Audiological Benefit With an Adhesively Attached, Noninvasive Bone Conduction Hearing System, Otol Neurotol, (2018). [27] U. Eyshold, Pädaudiologische Diagnostik [Paedaudiological Diagnostics], In: Wendler J, Seidner W, Eyshold U, Thieme, 2005, pp. 340. [28] B. Hakansson, S. Reinfeldt, M. Eeg-Olofsson, P. Ostli, H. Taghavi, J. Adler, J. Gabrielsson, S. Stenfelt, G. Granstrom, A novel bone conduction implant (BCI): engineering aspects and preclinical studies, Int J Audiol, 3 (2010) 203-215. [29] C.P. Goetzinger, Word discrimination testing, In: Katz J, Williams & Williams, 1978, pp. 149 - 158. [30] Y. Wang, X. Fan, P. Wang, Y. Fan, X. Chen, Hearing improvement with softband and implanted bone-anchored hearing devices and modified implantation surgery in patients with bilateral microtia-atresia, Int J Pediatr Otorhinolaryngol, (2018) 120-125. [31] P.H. Skarzynski, Olszewski, L., Ratuszniak, A., Osinska, K., Krol, B. , Audiological evaluation of the novel bone conduction hearing device ADHEAR in experienced users of an existing transcutaneous bone anchored hearing device. , Osseo 2017 Nijmegen, Netherlands, 2017. [32] C.V. Verhagen, M.K. Hol, W. Coppens-Schellekens, A.F. Snik, C.W. Cremers, The Baha Softband. A new treatment for young children with bilateral congenital aural atresia, Int J Pediatr Otorhinolaryngol, 10 (2008) 1455-1459. [33] T. Oranges, V. Dini, M. Romanelli, Skin Physiology of the Neonate and Infant: Clinical Implications, Adv Wound Care (New Rochelle), 10 (2015) 587-595. [34] G. Mertens, A. Gilles, R. Bouzegta, P. Van de Heyning, A Prospective Randomized Crossover Study in Single Sided Deafness on the New Non-Invasive Adhesive Bone Conduction Hearing System, Otol Neurotol, (2018).

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T0 unaided

*

10 20

*

ns

T0 BCDS

** ** ns

** ** *

** ** ns

* *

ns

* *

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ns

40

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50

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60 70

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dB [HL]

30

T0 ADHEAR

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80 90 100

0.25

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8 [kHz]

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0 10

**

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**

20

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dB [HL]

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90 100

T0 unaided

T0 ADHEAR

T1 ADHEAR

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*

ns

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100

SC M AN U TE D

60

20

0

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WRS in quiet [%]

80

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T0 BCDS

T0 ADHEAR

T1 ADHEAR

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*

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ns

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*

ns

*

*

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Speech

T1 ADHEAR

Spatial

Quality

Total

ACCEPTED MANUSCRIPT n = 10 (100%)

Answer

____ hours a day

Did the ADHEAR adhesive adapter fall off □ Never during normal usage? □ Only once □ Less than once a week □ More than once a week □ Every day

No answer

1-4 hours a day

5-7 hours a day

>8 hours a day

n =1

n =3

n =1

n =5

No answer

More than once a week

Less than once a week

Only once

Never

n =1

n =3

n =3

n =1

n =2

How often did your child on average change □ Less than once a week the ADHEAR adhesive □ Once a week □ Twice a week adapters? □ Every second day □ Every day

Did your child suffer from skin problems or irritation from the ADHEAR adhesive adapter?

□ Most of the time one attempt was needed. □ Most of the time more than one attempt was needed. □ Help was required. □ Most of the time one attempt was needed. □ Most of the time more than one attempt was needed. □ Help was required.

□ No, never □ Yes, a little □ Yes, bothersome □ Yes, very bothersome

Help was requiered

Most of the time more than one attempt was needed

n =1

n =2

Yes, very bothersome

n =2

n =7

Yes, but it does not annoy my child

n =4

Rarely, sometimes Hardly ever, most of the time my child my child didn´t notice it didn´t notice it n =1

n =3

Yes, a little

No, never

n =4

n =5

Valuable

Very valuable

n =2

n =3

n =5

No answer

No

Yes

n =2

n =3

n =5

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□ Hardly ever □ Rarely □ Most of the time

n =2

Most of the time one attempt was needed

Not valuable

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How did your child rate □ Very good the sound quality from □ Good the device? □ Acceptable □ Bad □ Very bad Has anyone noticed your child wearing a hearing device?

n = 10

n =1

□ Yes, __ □ No, __

Once a week

Most of the time one attempt was needed

□ Hardly ever, most of the time my child didn´t notice it Yes, my child is annoyed □ Rarely, sometimes my child by it didn´t notice it □ Yes, but it does not annoy my child n =2 □ Yes, my child is annoyed by it

Were the hearing device and the adapter a □ Very valuable □ Valuable valuable aid for your □ Partially valuable child? □ Not valuable Did your child speak more clearly when he/she was using the ADHEAR?

n =1

Twice a week

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Did your child notice wearing the Adhesive Adapter?

n =5

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What is your child`s experience in putting the audio processor back on the adhesive adapter behind the ear?

Every second day

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Question How many hours a day did you/your child use the ADHEAR system?

No answer

Acceptable

Good

Very good

n =3

n =1

n =3

n =3

No answer

Most of the time

Rarely

Hardly ever

n =1

n =3

n =3

n =3