BONEBRIDGE Bone Conduction Implant in Adults

MED-EL

Status

Terminated

Conditions

Hearing Loss, Conductive

Hearing Loss, Mixed

Treatments

Device: BONEBRIDGE

Study type

Interventional

Funder types

Industry

Identifiers

NCT03859648

MED-EL BB

Details and patient eligibility

About

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 assess safety and effectiveness of the BONEBRIDGE implant.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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