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NCT05615649 Clinical Trial

Expanded Indications in the Pediatric BONEBRIDGE Population

Hearing Loss, Conductive Clinical Trial

Official title:
Expanded Indications in the Pediatric BONEBRIDGE Population

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05615649
Other study ID # G220197
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 3, 2023
Est. completion date August 2025

Study information
Verified date November 2023
Source Med-El Corporation
Contact MED-EL Corporation
Phone 1-888-633-3524
Email research.us@medel.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• MED-EL BONEBRIDGE Bone Conduction Implant
Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.

Locations
Country Name City State
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 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 Utah Health/Primary Children's Hospital Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Med-El Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Functional gain Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds Up to six (6) months post-activation
Primary Adverse events Number and proportion of subjects experiencing serious device- and surgery-related adverse events Up to six (6) months post-activation
Secondary 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
Secondary 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
Secondary Post-intervention quality-of-life questionnaire Total and subscale scores on Glasgow Children's Benefit Inventory Up to six (6) months post-activation
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Active, not recruiting NCT05166265 - Clinical Investigation Study of Safety and Performance of the Sentio System. N/A
Completed NCT04761926 - Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid N/A
Completed NCT01796236 - Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique N/A
Completed NCT06256081 - Testing a New App for Children With Glue Ear N/A
Completed NCT04427033 - The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study