A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults (NCT07287124)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Rocky Mountain Ear Center — Englewood, Colorado
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- Rocky Mountain Ear Center — Englewood, Colorado
- University of Miami School of Medicine — Miami, Florida
- University of Iowa — Iowa City, Iowa
- Michigan Ear Institute — Novi, Michigan
- Mayo Foundation Rochester — Rochester, Minnesota
- Midwest Ear Institute — Kansas City, Missouri
- Washington University School of Medicine — St Louis, Missouri
- NYU Langone Health — New York, New York
- University Hospitals Cleveland Medical Centre — Beachwood, Ohio
- Hearts for Hearing Foundation — Oklahoma City, Oklahoma
- University of Utah Hospitals and Clinics — Salt Lake City, Utah
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hearing Loss, Bilateral Sensorineural
- Cochlear Implantation and Social Outcomes — Los Angeles, California
Explore by condition: All Hearing Loss, Bilateral Sensorineural clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.