Case Report: From soft headband to surgery: perspectives on the transition to surgical bone conduction devices in children

1 Introduction

A Bone Conduction Device (BCD) is used to treat hearing loss for individuals who have contraindications for using air conduction hearing aids with conductive or mixed hearing losses, as well as those with unilateral profound sensorineural hearing loss (i.e., single-sided deafness/limited usable hearing unilaterally; Bagatto et al., 2022; Desmet et al., 2011; Ellsperman et al., 2021). BCDs can be non-surgical or surgically implanted (Figure 1). A variety of non-surgical and surgical BCDs are currently offered across multiple manufacturers (Ellsperman et al., 2021). Surgically implanted BCDs deliver sound vibrations to the skull via a direct-drive percutaneous abutment or an active transcutaneous magnetic connection (Ellsperman et al., 2021; Mylanus et al., 2020; Reinfeldt et al., 2015). Non-surgical BCDs are widely used in young children because they allow early auditory access; however, consensus guidelines note limitations in output and high-frequency transmission compared to surgical solutions (Bagatto et al., 2022).

In the United States, age-related candidacy criteria for surgical BCD implantation are established by the Food and Drug Administration (FDA) based on device-specific indications. Percutaneous systems, Cochlear Baha Connect and Oticon Medical Ponto, and the Cochlear Osia^® active transcutaneous implant, are approved for children 5 years and older (Cochlear, 2025; U.S. Food Drug Administration, 2015), whereas MED-EL BONEBRIDGE™ and the Oticon Medical Sentio™ active transcutaneous systems are approved for children aged 12 years and older (U.S. Food Drug Administration, 2018, 2024).

Numerous studies have demonstrated the clinical and functional benefits of surgical bone conduction system in children and adults (Gordon et al., 2022; Tejani et al., 2025; Young et al., 2023). Benefits include improvements in speech perception, listening effort, and quality of life across pediatric and adult populations (Hol et al., 2005; Mylanus et al., 2020). Pittman (2019) demonstrated percutaneous abutment systems provide significantly more gain, better high frequency transmission, and improved speech perception abilities than those worn on a soft headband. However, percutaneous abutments in children carry risks of soft tissue complication, which include skin overgrowth, irritation, and infection around the abutment site (Ellsperman et al., 2021).

In a multicenter prospective study evaluating audiologic and quality-of-life outcomes in children 5–11 years old implanted with the Cochlear Osia^® system, Tejani et al. (2025) reported significantly greater benefit with the Cochlear Osia^® compared to testing with the Baha^® 5 Power on a soft headband. Study participants reported full-day device use, and both child and caregiver validation questionnaires revealed meaningful improvement in listening ease, communication, and overall hearing-related quality of life (Tejani et al., 2025).

For children under 5 years old, fitting a non-surgical BCD on a soft headband is a common intervention to ensure early exposure to sound (Bagatto et al., 2022), which is crucial for spoken language, cognitive, and social development (Yoshinaga-Itano et al., 2017). As children grow and encounter more complex listening environments-such as classrooms, organized sports and playground settings-multiple speakers, greater distance, and increased background noise create more challenging listening conditions, which can impact their ability to communicate with others (Cristofari et al., 2017). Although access to high-frequency sounds is critical, high frequency transmission is often reduced due to skin transmission loss when wearing a non-surgical device (Bagatto et al., 2022; Pittman, 2019). While a BCD on a soft headband is an excellent option for young children, transitioning to a surgical solution offers several advantages beyond eliminating the need for a headband.

Despite expanding evidence supporting surgical BCD outcomes in children, limited literature describes real-world clinical transition from non-surgical soft headband use to implantation, particularly from a family-centered decision-making perspective. This transition represents a period where, age of the child, audiologic benefit, developmental needs, anatomical considerations, and psychosocial factors be evaluated together. Understanding how these elements interact in clinical practice can guide providers in supporting families' decisions as they explore technology options.

This case report illustrates the clinical decision-making process, family-centered counseling and functional outcomes associated with transitioning from a non-surgical to surgical BCD in a young child. Given the variety of available surgical bone conduction solutions, device selection may require individualized considerations. The participant's journey is guided by evidence- based practice guidelines (EBPGs) developed at Children's Hospital of Philadelphia (CHOP) for managing children with BCDs, integrating scientific evidence with clinical experience (Children's Hospital of Philadelphia, 2024). Details will include the participant's audiological profile, referrals to additional specialists, clinical reasoning for selecting a surgical BCD, and post-implantation outcomes. This guideline includes information about surgical and non-surgical BCDs. It is organized into five sections: (1) assessment and audiologic candidacy, (2) device selection (including desired pediatric product characteristics), (3) fitting considerations, (4) verification and validation, and (5) management and follow-up (Bagatto et al., 2022).

As part of comprehensive care, families at CHOP may also be referred to the Integrated Psychosocial Program (IPP) for counseling and support. Through this program, families meet with a behavioral health professional to receive comprehensive, holistic support for their child. The psychosocial evaluation helps understand the child's social, emotional, and behavioral functioning in the context of their hearing loss and provides support in navigating decisions around hearing loss (i.e., pursuing surgery). By integrating psychosocial care, the clinical team ensures that both the emotional and practical aspects of hearing health are addressed, supporting not only communication but also confidence, resilience, and quality of life for the child and family.

2 Case description

2.1 Non-surgical candidacy considerations

T.D. was born premature at 34 weeks gestation with a Neonatal Intensive Care Unit (NICU) stay of 15 days. He had hemifacial microsomia and atresia/microtia of the right ear, with a typically appearing left pinna. He passed his newborn hearing screening in the left ear and referred in the right ear. Diagnostic auditory brainstem response (ABR) testing was completed at 2 months of age using the Intelligent Hearing Systems (IHS) Duet SmartEP. Two-channel recordings were obtained, and waveform interpretation included comparison of amplitude and latency between ipsilateral and contralateral tracings to confirm stimulation of the test ear (Bagatto and Scollie, 2019). Bone conduction thresholds were obtained at 20 dB eHL, the minimum test level, at 500, 1000, 2000, and 4000 Hz. Air-conduction testing of the right ear was not performed due to confirmed atresia of the ear canal on otoscopic examination (Bagatto et al., 2022). Results demonstrated normal hearing sensitivity in the left ear and a presumed maximum conductive hearing loss in the right ear. Masked air conduction testing of the right ear using TDH headphones was completed during behavioral audiologic testing at a later time. Recommendations included an otologic evaluation to obtain medical clearance for hearing device use, a BCD evaluation, referral for early intervention services, referral to IPP provider, and a Speech-Language Evaluation.

T.D.'s BCD evaluation was completed when he was 7 months old, just past the optimal goal of amplification fitting at 6 months old or within 4 weeks of diagnosis (Bagatto et al., 2022; Joint Committee on Infant Hearing, 2019). This evaluation included a review of all amplification options and remote microphone systems. BCDs are recommended for individuals who have the inability to use conventional air conduction amplification due to congenital anomalies or conditions of the outer or middle ear (Ellsperman et al., 2021). A BCD was recommended over an air conduction hearing aid due to atresia and microtia, as T.D. could not support an earmold required for acoustic coupling of an air conduction hearing aid. Contralateral-routing-of-signal (CROS) systems, typically recommended for older children with unilateral severe to profound sensorineural hearing loss (Bagatto et al., 2023), and personal ear level remote microphone technologies alone do not provide direct stimulation to the affected ear. Given T.D.'s young age, the discussion focused on all available non-surgical transcutaneous BCD options.

During the evaluation, the potential benefits of fitting a BCD for unilateral conductive hearing loss were discussed in the context of T.D.'s symmetrical bone conduction thresholds, defined as less than a 10 dB difference in bone-conduction pure-tone average between ears or less than a 15 dB interaural difference at individual frequencies (Bagatto et al., 2022). These benefits included the ability to provide binaural hearing, the potential prevention of auditory deprivation, improved sound localization and directionality, better speech perception in noisy environments, and reported improvements in both objective and subjective hearing outcomes (Polonenko et al., 2016; Sharma et al., 2002; Vogt et al., 2018; Vyskocil et al., 2017).

In selecting a BCD for T.D., device features were evaluated in accordance with the considerations outlined by Bagatto et al. (2022). Key characteristics included a tamper resistant battery door, compatibility with a remote microphone system, access to datalogging, and the ability to adjust or deactivate noise management features. Additional considerations included the option to disable the programming button and volume control, compatibility with a skull simulator coupler for device verification, and the ability to obtain in-situ BCD threshold measurements. Devices with higher maximum force output (MFO), including power devices, were then considered to help ensure adequate output limitations.

At the time of the initial device selection and throughout the period during which T.D. used a non-surgical soft headband BCD, prescriptive DSL-BC targets were not available for soft headband fittings and a recommendation regarding minimum MFO were not available (Bagatto et al., 2022). T.D. was therefore initially fitted with a Cochlear Baha^® 5 on a soft headband for the right ear. At 3 years old, he was subsequently fitted with a Cochlear Baha^® 6 Max, also on a soft headband. The Cochlear Baha^® 6 Max was selected for its pediatric features and device characteristics appropriate for young children, as well as its higher maximum force output (Bagatto et al., 2022).

As stated in our EBPG for management of children with BCDs, T.D. attended audiology visits every 3–6 months, with updates to his case history and early intervention support services, audiologic monitoring of both ears, completion of in-situ BCD thresholds within the manufacturer's software, and validation measures. Validation categories include access to information (i.e., device usage/datalogging), age-appropriate aided speech perception testing, and standardized outcome measures/counseling tools (Children's Hospital of Philadelphia, 2024).

T.D. was seen for a Speech-Language evaluation at 2 years old to assess his language and speech production skills. T.D.'s results, with the Preschool Language Scale-5th Edition, revealed age-appropriate receptive and expressive language skills. Speech production skills were not measured using a standardized assessment, however, based on the clinician's knowledge of phonemic repertoire, T.D. measured age-appropriate skills for speech production. It was recommended that T.D. continue speech-language therapy and hearing support services from the Teacher of the Deaf to continue to foster development of receptive language, expressive language, and speech production.

At 5 years old, T.D. completed a candidacy evaluation for a surgical BCD. During the evaluation, we reviewed that an exact demonstration of a surgical BCD is not possible, as differences exist between soft headband transmission and implanted systems. However, the benefit demonstrated with a BCD soft headband can provide some indication of expected postoperative performance and ease in the transition to a surgical BCD (Bagatto et al., 2022).

2.2 Surgical BCD candidacy considerations

Audiologic testing completed using conditioned play audiometry with TDH headphones revealed a moderate conductive hearing loss in the right ear and normal hearing in the left ear. Masking was applied to the left ear with an insert earphone during both air conduction and bone conduction testing (Bagatto et al., 2022). These findings confirmed that T.D. met audiologic candidacy criteria for a surgical bone conduction device in the right ear. Pre-surgical counseling included a review of the current surgical BCD options and manufacturers, along with a discussion of the benefits of surgical implantation compared with continued soft headband use. These benefits included improved aided thresholds and speech perception in testing, enhanced overall sound quality and performance, faster learning rates, improved working memory, and subjective measures (Gordon et al., 2022; Pittman, 2019; Polonenko et al., 2016; Tejani et al., 2025).

The available surgical BCD options were discussed (Figure 2). A percutaneous implant was not considered due to known concerns regarding skin overgrowth and infection often associated with abutments (Ellsperman et al., 2021; Pittman, 2019; Young et al., 2023). T.D. and his parents expressed interest in pursuing a surgically implanted active transcutaneous BCD. MRI compatibility is an important consideration when selecting surgical BCDs in pediatric populations, as these devices contain internal magnets and are classified as MRI conditional. Device specific MRI precautions and possible long-term imaging considerations were discussed with the family. Based on age eligibility, audiologic candidacy, and family preference, the Cochlear Osia^® system was selected. Audiologic indications include children and adults aged 5 years and older with conductive or mixed hearing loss in one or both ears or those with unilateral profound sensorineural hearing, also known as single-sided deafness/limited usable hearing unilaterally (Cochlear, 2025).

T.D.'s surgical evaluation for Cochlear Osia^® candidacy included MRI considerations (MR conditional up to 3.0T), a review of the surgical procedure, and a discussion of recovery and follow-up. Additionally, since the family was considering ear reconstruction for right sided microtia, he was evaluated by the plastic surgery team. Following consultation, both the plastic and otology surgeons recommended a single-stage procedure combining polyethylene ear reconstruction and Cochlear Osia^® implantation. Performing both procedures concurrently not only avoids the need for additional surgery but also optimizes timing, providing earlier access to the audiologic benefits of a surgically implanted BCD (Ryan et al., in review).

2.3 Surgical BCD results

At 5 years old, T.D. underwent implantation with a Cochlear Osia^® OSI300, and his Osia^® 2 sound processor was activated 4 weeks following surgery, consistent with the manufacture guidance (Cochlear, 2025) Aided testing was performed postoperatively with the Cochlear Osia^® 2 and compared to preoperative results with the Cochlear Baha^® 6 Max soft headband. It is important to note that this case study reflects real-world clinical testing procedures in children rather than a controlled research study with a standardized protocol. Accordingly, aided testing was conducted within the constraints of a single clinical appointment. Speech perception tests were selected based on the child's age and developmental abilities, and identical test materials were not administered across the non-surgical and surgical conditions.

2.3.1 Audiologic testing

All testing and counseling on non-surgical and surgical BCD options followed CHOP's EBPG to ensure that the care provided adhered to established standards of quality, consistency, and effectiveness. Contralateral masking was presented to the left ear via an insert earphone during unaided and aided testing (Bagatto et al., 2022; Figure 3).

Audiologic testing included:

• Unaided pure tone audiometry: threshold determination using conditioned play audiometry was obtained for air and bone conduction in both ears.
• Recorded aided speech perception testing: conducted via a speaker at 0° azimuth with masking applied to the non-test ear for all conditions except when indicated. Speech stimuli were presented at 0° azimuth at conversational levels in quiet (60 dBA), soft levels in quiet (50 dBA), and conversational levels in noise (65 dBA), with both speech and noise presented at 0° azimuth (Olsen, 1998). Tests included:

• - Phonetically Balanced Kindergarten (PBK-50): open-set word recognition.
• - Bamford-Kowal-Bench Speech in Noise (BKB-SIN): assesses sentence recognition in noise; results reported as SNR-50 (signal-to-noise ratio for 50% correct). One point is calculated for each key word repeated correctly. Key words are underlined on the score sheets. The total number of correct words for each sentence is added together and then subtracted from 23.5 to obtain the SNR-50. Each paired list is scored and averaged together (Bench et al., 1979; Holder et al., 2016; Uhler et al., 2017). Sentences presented at 60 dB HL in the soundfield. Masking was not presented to the non-test ear for this aided condition.
• - Consonant-Nucleus-Consonant (CNC) Word Test: 50 monosyllabic words with balanced phonemic distribution. Pediatric AZ Bio Sentences: sentence recognition in noise using lists of 20 sentences spoken by a single female talker.

• Recorded LING-6(HL) Sound Detection assessed T.D.'s ability to detect six speech frequency sounds (Scollie et al., 2012).
• Device usage (i.e., datalogging)
• Outcome Measures with the Cochlear Osia^®

• - Vanderbilt Fatigue Scale-Children and Vanderbilt Fatigue Scale-Parent, both designed to identify significant listening- related fatigue in school-aged children (child report and parent proxy, respectively), indicated that T.D. scored below the at-risk range for frequent listening-related fatigue problems (Hornsby et al., 2022).
• - Aided Vanderbilt Classroom Listening Assessment Short Survey (VCLASS) was administered to monitor the listening development and quantify the challenges that school-aged children with unilateral hearing loss experience. Students are asked to answer questions as if they were using their hearing device. T.D.'s scores were as follows: Total = 4.53, Far = 4.5, Near Inside = 5.0, and Near Outside = 4.33. A high score (>3) indicates that listening in school-based environments is relatively easy for T.D. while using his device (Picou et al., 2024; Figure 4).

3 Discussion/Conclusion

Early access to hearing technology is critical for supporting language, cognitive, and social development in children with hearing loss (Yoshinaga-Itano et al., 2017). Non-surgical BCDs are commonly used in young children with conductive, mixed, or single-sided deafness/limited usable hearing unilaterally, as they are non-invasive and easily adjustable during the early years, but have limitations compared to an implantable system.

The literature acknowledges that soft headband devices may be limited in output and high-frequency transmission relative to implanted bone conduction systems (Bagatto et al., 2022; Pittman, 2019). Emerging pediatric surgical BCD outcomes literature supports the clinical rationale for considering surgical BCDs over continued use of a soft headband device. Tejani et al. (2025) reported improved performance following transition from non-surgical to implanted bone conduction technology in children, and the multicenter pediatric trial data similarly demonstrated gains in aided thresholds and speech perception following Cochlear Osia^® implantation.

From a parent/family perspective, the decision to move forward with a surgical BCD solution can bring a mix of emotional and practical concerns. Many families experience hesitation about the procedure itself, recovery time, and associated risks. There are also emotional impacts and considerations, such as concerns about their child's comfort, appearance, and adjustment to a more permanent and different hearing solution. At the same time, parents often find themselves balancing the potential benefits and the risks of transition. Ultimately, parents want reassurance that their child will not only hear better but also feel confident and supported throughout the process. Although T.D.'s family reported significant satisfaction with their decision to pursue the Cochlear Osia^® system, some families may have reservations or concerns when considering this option.

For children and families exploring the transition to surgical BCD, effective counseling is essential for addressing emotional concerns, clarifying audiological benefits, and managing risks and expectations. This support helps alleviate anxiety and provides families with continuous reassurance. Counseling also fosters a collaborative relationship between families and clinicians, empowering and supporting patients and their families throughout the journey.

This case report illustrates a clinical pathway for a child with unilateral conductive hearing loss, from diagnosis and early amplification through transition to a surgical bone conduction solution. Additionally, this report highlights the importance of audiologists recognizing the potential auditory benefits pediatric patients may miss when surgical BCDs are not considered. This paper serves as a clinical guide outlining key hearing performance benefits and essential counseling considerations associated with surgical BCDs.

A strength of this case is the comparison between non-surgical and surgical bone conduction devices within a pediatric case study. The multidisciplinary care that includes audiology, ENT, speech pathology, and psychosocial support captures functional and family-reported outcomes in addition to audiometric measures. Several limitations should also be considered. As a single case report, the findings are not broadly applicable; testing was conducted as routine clinical care rather than a controlled research protocol; audiologic tests are influenced by developmental variability; and family-reported satisfaction reflects individual experience.

This case is intended to be illustrative and should not be interpreted as definitive evidence that one intervention is superior to another. Nevertheless, when interpreted alongside the growing pediatric surgical BCD literature (Gordon et al., 2022; Pittman, 2019; Polonenko et al., 2016; Tejani et al., 2025; Young et al., 2023), this case supports the clinical importance of timely evaluation and counseling for surgical bone conduction options when appropriate, to optimize auditory access and functional outcomes.

Future research involving larger pediatric cohorts, various manufacturers, and standardized outcome frameworks is needed to clarify optimal timing of transition from non-surgical to implanted bone conduction solutions and to evaluate long-term developmental and quality-of-life outcomes.

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Footnotes

Edited by: Marlene Bagatto, Western University, Canada

Reviewed by: Qusai Tawakkul, Ministry of Health, Saudi Arabia

Christine Brown, Western University, Canada