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

NCT07287124 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-05-22

No results posted yet for this study

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

DEVICE

Cochlear implant

Totally Implantable Cochlear Implant System

Sponsors & Collaborators

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Craig Buchman · University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-10-31
Completion
2028-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07287124 on ClinicalTrials.gov