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

This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system. The system includes a microphone placed under the skin to detect speech and sound from the environment, providing the option to hear without any visible external parts. This study will involve 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). Participants will complete hearing tests and questionnaires to evaluate how well the system works and how it affects their daily life.

NCT Number	NCT07287124
Lead Sponsor	Cochlear
Conditions	Hearing Loss, Bilateral Sensorineural
Enrollment	56 participants
Start Date	2026-04-03
Primary Completion	2027-10 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-31