Trials / Recruiting
RecruitingNCT07139327
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
A Pre-market, Prospective, Interventional, Multicenter, Pivotal Study to Evaluate Efficacy and Safety of a Totally Implantable Cochlear Implant System in an Adult Population With Sensorineural Hearing Loss
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cochlear Implant | TICI G2 Clinical Investigation System |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2027-04-01
- Completion
- 2027-10-01
- First posted
- 2025-08-24
- Last updated
- 2026-03-18
Locations
8 sites across 2 countries: Australia, France
Source: ClinicalTrials.gov record NCT07139327. Inclusion in this directory is not an endorsement.