NCT07287124

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

A Pivotal, Pre-market, Prospective, Interventional, Multi-centre Study to Evaluate Clinical Benefit, Performance, and Safety of the TI1132 Implant in an Adult Population With Sensorineural Hearing Loss

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hearing Loss, Bilateral Sensorineural

Interventions

Type	Name	Description
DEVICE	Cochlear implant	Totally Implantable Cochlear Implant System

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-10-01
• Completion: 2028-08-01
• First posted: 2025-12-17
• Last updated: 2026-04-09

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study