Expanded Indications in the Pediatric BONEBRIDGE Population

Running, not enrolling · Not applicable

Conditions studied: Hearing Loss, Conductive, Hearing Loss, Mixed

In brief

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 facts

Study ID

NCT05615649

Run by

Med-El Corporation

People needed

36

Starts

2023-10-03

Expected to finish

2026-07-01

Last updated by the study team

2026-06-29

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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