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ACTIVE NOT RECRUITING
NCT05615649
NA

Expanded Indications in the Pediatric BONEBRIDGE Population

Sponsor: Med-El Corporation

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

3 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-10-03

Completion Date

2026-07

Last Updated

2025-09-24

Healthy Volunteers

No

Interventions

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 (6)

University of Colorado Health/Children's Hospital of Colorado

Aurora, Colorado, United States

University of Miami

Miami, Florida, United States

University Hospital Newark/Rutgers New Jersey Medical School

Newark, New Jersey, 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 Utah Health/Primary Children's Hospital

Salt Lake City, Utah, United States