A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults

This clinical study examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment allowing the option to hear without the need of an external sound processor. This implant will be tested in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing and overall general health.

NCT Number	NCT07139327
Lead Sponsor	Cochlear
Conditions	Hearing Loss, Bilateral Sensorineural
Enrollment	36 participants
Start Date	2025-12-01
Primary Completion	2027-04 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2026-04-29