Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness

Exclusion Criteria

• •1. Alleviation of tinnitus as the stated primary or sole motivation for seeking implantation by the subject and/or investigator.
• •2. Actively using an implantable device in the poorer ear.
• •3. Onset of severe to profound hearing loss \< 6 years-of-age.
• •4. Evidence of active middle-ear pathology based on otologic examination and/or immittance testing.
• •5. Medical or psychological conditions that contraindicate undergoing surgery.
• •6. Ossification or any other cochlear anomaly at the implant ear that might prevent complete insertion of the electrode array.
• •7. Hearing loss of neural or central origin, including auditory neuropathy.
• •8. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure and prosthetic device.
• •9. Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure, as determined by the investigator.