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

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Cochlear
Study ID
NCT07287124
Status
Recruiting
Apply to this trial

Conditions

  • Hearing Loss, Bilateral Sensorineural

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cochlear implant — DEVICE
    Totally Implantable Cochlear Implant System

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Totally Implantable Cochlear Implant System
    Participants will be implanted with the TI1132 implant

Primary Outcome Measure

Speech recognition performance in quiet [ Time Frame: Preimplantation to 6-months post-activation ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Rocky Mountain Ear CenterEnglewoodColorado80113
David Kelsall (PRINCIPAL_INVESTIGATOR)
University of Miami School of MedicineMiamiFlorida33136
Sandra Prentiss (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Bruce Gantz (PRINCIPAL_INVESTIGATOR)
Michigan Ear InstituteNoviMichigan48374
Robert Hong (PRINCIPAL_INVESTIGATOR)
Mayo Foundation RochesterRochesterMinnesota55902
Matthew Carlson (PRINCIPAL_INVESTIGATOR)
Midwest Ear InstituteKansas CityMissouri64111
Robert Cullen (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63108
Jacques Herzog (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10017
J. Thomas Roland Jr. (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CentreBeachwoodOhio44122
Alejandro Rivas (PRINCIPAL_INVESTIGATOR)
Hearts for Hearing FoundationOklahoma CityOklahoma73120
Rene Gifford (PRINCIPAL_INVESTIGATOR)
University of Utah Hospitals and ClinicsSalt Lake CityUtah84132
Richard Gurgel (PRINCIPAL_INVESTIGATOR)

Find similar trials in Englewood, CO

By research site
Rocky Mountain Ear Center· Englewood, COUniversity of Miami School of Medicine· Miami, FLUniversity of Iowa· Iowa City, IAMichigan Ear Institute· Novi, MIMayo Foundation Rochester· Rochester, MNMidwest Ear Institute· Kansas City, MO

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