Status:
TERMINATED
BONEBRIDGE Bone Conduction Implant in Adults
Lead Sponsor:
Med-El Corporation
Conditions:
Hearing Loss, Conductive
Hearing Loss, Mixed
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to a...
Eligibility Criteria
Inclusion
- Adults, 18 years of age or older at the time of implantation
- Conductive or mixed hearing loss, defined as:
- Conductive hearing loss with pure-tone average (PTA) for bone conduction thresholds better than or equal to 25 dB at 500, 1000, 2000 and 3000 Hz
- Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz
- Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz
- Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better
- Bilateral BONEBRIDGE can be considered if the difference in PTA for bone conduction thresholds is 10 dB or less between the right and left ears
- Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
- Able to complete testing materials in English
- CT scan indicating the patient's anatomy is adequate to enable placement of the implant
- Ability to undergo general anesthesia
- Appropriate motivation and expectation levels
- Stated willingness to comply with all study procedures for the duration of the study
Exclusion
- Evidence that hearing loss is retrocochlear in origin
- Skin or scalp condition precluding use of external audio processor
- Suspected cognitive impairment or organic brain dysfunction
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03859648
Start Date
August 26 2019
End Date
November 4 2022
Last Update
May 30 2024
Active Locations (3)
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1
The Ohio State Wexner Medical Center University
Columbus, Ohio, United States, 43081
2
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5