Expanded Indications in the Pediatric BONEBRIDGE Population

Study Overview
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Brief Summary
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This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.

Detailed Description
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This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.

Official Title
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Expanded Indications in the Pediatric BONEBRIDGE Population

Conditions
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Hearing Loss, Conductive, Hearing Loss, Mixed

Intervention / Treatment
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* Device: MED-EL BONEBRIDGE Bone Conduction Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Under 12 years of age Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted Sufficient air-bone gap (ABG) at in the ear to be implanted HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons Parental commitment to comply with all study procedures Exclusion Criteria: Children under 3 years (36 months) of age Chronic or non-revisable vestibular or balance disorders Abnormally progressive hearing loss Prior use of a hearing implant in the ear to be implanted Current/ongoing use of a hearing implant in the contralateral/non-implant ear Evidence that hearing loss is retrocochlear in origin Medical condition that contraindicates implant surgery or anesthesia Skin or scalp condition precluding use of external audio processor

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study procedure<br>This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation. | Device: MED-EL BONEBRIDGE Bone Conduction Implant<br>* Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.<br>* Other names: BCI 602;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional gain | Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds | Up to six (6) months post-activation | 
| Adverse events | Number and proportion of subjects experiencing serious device- and surgery-related adverse events | Up to six (6) months post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word recognition score | Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score | Up to six (6) months post-activation | 
| Unaided bone-conduction pure-tone average (BC-PTA) | Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA | Up to three (3) months post-activation | 
| Post-intervention quality-of-life questionnaire | Total and subscale scores on Glasgow Children's Benefit Inventory | Up to six (6) months post-activation |