Assessing a Bone Conduction Implant for Children with Hearing Loss
Expanded Indications in the Pediatric BONEBRIDGE Population
This study is testing a new bone conduction implant to see if it helps children under 12 with hearing loss hear better and improve their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Med-El Corporation Industry-sponsored |
| Locations | 6 sites (Aurora, Colorado and 5 other locations) |
| Trial ID | NCT05615649 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old who suffer from conductive or mixed hearing loss. It is a prospective multicenter study involving 36 children across six academic medical centers in the United States. Participants will be assessed for their hearing improvement and overall outcomes following the implantation of the device. The study aims to provide insights into the expanded use of this technology in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates are children under 12 years old with specific hearing loss criteria and prior experience with hearing aids.
Not a fit: Patients under 3 years old or those with progressive hearing loss or other specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve hearing capabilities and quality of life for children with specific types of hearing loss.
How similar studies have performed: Other studies have shown positive outcomes with similar bone conduction implants, indicating a promising approach for this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado and 5 other locations
- University of Colorado Health/Children's Hospital of Colorado — Aurora, Colorado, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- University Hospital Newark/Rutgers New Jersey Medical School — Newark, New Jersey, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
- The Ohio State University/Nationwide Children's Hospital — Columbus, Ohio, United States (Not_yet_recruiting)
- University of Utah Health/Primary Children's Hospital — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: MED-EL Corporation
- Email: research.us@medel.com
- Phone: 1-888-633-3524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.