Expanded Indications in the Pediatric BONEBRIDGE Population

Description

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.

Conditions

Hearing Loss, Conductive, Hearing Loss, Mixed

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Study Overview

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Study Details

Study overview

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.

Expanded Indications in the Pediatric BONEBRIDGE Population

Expanded Indications in the Pediatric BONEBRIDGE Population

Condition
Hearing Loss, Conductive
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Health/Children's Hospital of Colorado, Aurora, Colorado, United States, 80045

Miami

University of Miami, Miami, Florida, United States, 33136

Newark

University Hospital Newark/Rutgers New Jersey Medical School, Newark, New Jersey, United States, 07103

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27517

Columbus

The Ohio State University/Nationwide Children's Hospital, Columbus, Ohio, United States, 43210

Salt Lake City

University of Utah Health/Primary Children's Hospital, Salt Lake City, Utah, United States, 84132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

3 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Med-El Corporation,

Study Record Dates

2025-08