Expanded Indications in the Pediatric BONEBRIDGE Population

Not Applicable

Recruiting

• Conditions: Hearing Loss, Conductive; Hearing Loss, Mixed
• Interventions: Device: MED-EL BONEBRIDGE Bone Conduction Implant

• Registration Number: NCT05615649
• Lead Sponsor: Med-El Corporation

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Study Start: 2023-10-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study procedure	MED-EL BONEBRIDGE Bone Conduction Implant	This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

The Ohio State University/Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University Hospital Newark/Rutgers New Jersey Medical School; 🇺🇸 Newark, New Jersey, United States

University of Colorado Health/Children's Hospital of Colorado; 🇺🇸 Aurora, Colorado, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University of Utah Health/Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States