RecruitingNot ApplicableNCT07287124

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


Sponsor

Cochlear

Enrollment

56 participants

Start Date

Apr 3, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cochlear implant for people with hearing loss, bilateral sensorineural. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECochlear implant

Totally Implantable Cochlear Implant System


Locations(11)

Rocky Mountain Ear Center

Englewood, Colorado, United States

University of Miami School of Medicine

Miami, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Michigan Ear Institute

Novi, Michigan, United States

Mayo Foundation Rochester

Rochester, Minnesota, United States

Midwest Ear Institute

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

University Hospitals Cleveland Medical Centre

Beachwood, Ohio, United States

Hearts for Hearing Foundation

Oklahoma City, Oklahoma, United States

University of Utah Hospitals and Clinics

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT07287124


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