Active, not recruitingNo phase
Expanded Indications in the Pediatric BONEBRIDGE Population
Key facts
- Who runs it
- Med-El Corporation
- Where
- Aurora, Chapel Hill, Columbus, Miami, Newark, and Salt Lake City, United StatesSee the 6 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 36 people enrolled
- Started
- 3 Oct 2023
- Ended
- Oct 2026
- Type of study
- Interventional
- Treatments tested
- MED-EL BONEBRIDGE Bone Conduction Implant
- Record updated
- 19 August 2026
Who can take part
- Age
- 3 years to 12 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Chronic or non-revisable vestibular or balance disorders
- Medical condition that contraindicates implant surgery or anesthesia
- Skin or scalp condition precluding use of external audio processor
- Children under 3 years (36 months) of age
- Abnormally progressive hearing loss
- Evidence that hearing loss is retrocochlear in origin
Where in United States
- University of Colorado Health/Children's Hospital of ColoradoAurora, United StatesNo longer taking part
- University of North CarolinaChapel Hill, United StatesNo longer taking part
- The Ohio State University/Nationwide Children's HospitalColumbus, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- University Hospital Newark/Rutgers New Jersey Medical SchoolNewark, United StatesNo longer taking part
- University of Utah Health/Primary Children's HospitalSalt Lake City, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Study procedureTreatment being tested
This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.
Treatment: MED-EL BONEBRIDGE Bone Conduction Implant
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 19 August 2026