BONEBRIDGE Bone Conduction Implant in Adults

Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE

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.

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

Exclusion Criteria:

• 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