Expanded Indications in the Pediatric BONEBRIDGE Population
NCT ID: NCT05615649
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
36 participants
INTERVENTIONAL
2023-10-03
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study procedure
This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
12 Years
ALL
No
Sponsors
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Med-El Corporation
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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G220197
Identifier Type: -
Identifier Source: org_study_id
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