Clinical trialNCT07287124RecruitingInterventional

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

SponsorCochlearEnrollment56Hearing Loss, Bilateral Sensorineural

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Craig Buchman
University of Utah
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Rocky Mountain Ear Center
Englewood, Colorado, United States
David Kelsall
Recruiting
University of Miami School of Medicine
Miami, Florida, United States
Sandra Prentiss
Recruiting
University of Iowa
Iowa City, Iowa, United States
Bruce Gantz
Recruiting
Michigan Ear Institute
Novi, Michigan, United States
Robert Hong
Recruiting
Mayo Foundation Rochester
Rochester, Minnesota, United States
Matthew Carlson
Recruiting
Midwest Ear Institute
Kansas City, Missouri, United States
Robert Cullen
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Jacques Herzog
Recruiting
Nyu Langone Health
New York, New York, United States
J. Thomas Roland Jr.
Recruiting
University Hospitals Cleveland Medical Centre
Beachwood, Ohio, United States
Alejandro Rivas
Recruiting
Hearts for Hearing Foundation
Oklahoma City, Oklahoma, United States
Rene Gifford
Recruiting
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
Richard Gurgel
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 3 Apr 2026
Primary completion: 31 Oct 2027
Completion: 31 Aug 2028
Last update posted: 31 Jul 2026
Registered enrollment: 56
Registry id: NCT07287124

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.