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

NCT07139327 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-29

No results posted yet for this study

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

  • Hearing Loss, Bilateral Sensorineural

Interventions

DEVICE

Cochlear Implant

TICI G2 Clinical Investigation System

Sponsors & Collaborators

  • Cochlear

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-04-30
Completion
2027-10-31

Countries

  • Australia
  • France

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 NCT07139327 on ClinicalTrials.gov