Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.

NCT Number	NCT06641999
Lead Sponsor	Cochlear
Conditions	Tinnitus, Hearing Loss, Bilateral or Unilateral, Normal Hearing
Enrollment	16 participants
Start Date	2025-06-16
Primary Completion	2027-07 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-02