BONEBRIDGE Bone Conduction Implant in Adults

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