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

NCT07287124 | Recruiting DMC FDA Device

• 1 other identifier: CLTD5828
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (2)

• Speech recognition performance in quiet

  Percent correct scores in word recognition score from pre-implantation to post-implantation.

  Preimplantation to 6-months post-activation

• Incidence of adverse events and device deficiencies

  Frequency and severity of device and procedure-related adverse events, including device deficiencies.

  Implantation to 6- and 12-months post-activation

Secondary Outcomes (7)

• Speech, Spatial and Qualities of Hearing questionnaire (SSQ-12)

  Preimplantation to 6- and 12-months post-activation

• Speech recognition performance in noise

  Preimplantation to 6- and 12-months post-activation

• Speech recognition performance in quiet

  Preimplantation to 12-months post-activation

• Cochlear Implant Quality of Life Profile (CIQOL-35)

  Preimplantation to 6- and 12-months post-activation

• Health Utilities Index (HUI 2/3)

  Preimplantation to 6- and 12-months post-activation

Study Arms (1)

Totally Implantable Cochlear Implant System

EXPERIMENTAL

Participants will be implanted with the TI1132 implant

Device: Cochlear implant

Interventions

Cochlear implant DEVICE

Totally Implantable Cochlear Implant System

Totally Implantable Cochlear Implant System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 years and older at time of consent.
• Clinically established sensorineural hearing loss (SNHL) defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥70 dB HL in the ear to be implanted.
• Compromised functional hearing in the aided condition defined as ≤40% correct on a word recognition test in the ear to be implanted.
• Clinically established SNHL defined by a four-frequency (500, 1000, 2000 \& 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥30 dB HL in the contralateral ear.
• Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.
• Direct access to a compatible Smart Phone.
• Willing and able to provide written informed consent.

You may not qualify if:

• Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
• Candidates with single-sided deafness as determined by the investigator.
• Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
• Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.
• Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
• Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.
• Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted.
• Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks.
• Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the participant.
• Severe, or poorer, sensorineural hearing loss for more than 20 years, as reported by the participant, in the ear to be implanted.
• Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation as determined by the investigator.
• Pre-existing skin condition that could jeopardize wound healing as judged by the investigator e.g., psoriasis, dermatitis, use of corticosteroids, uncontrolled diabetes.
• Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator.
• Additional disabilities that may affect the participant's participation or safety during the clinical investigation.
• Unable or unwilling to comply with all requirements of the clinical investigation, as determined by the investigator.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (11)

Rocky Mountain Ear Center

Englewood, Colorado, 80113, United States

RECRUITING

University of Miami School of Medicine

Miami, Florida, 33136, United States

NOT YET RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Michigan Ear Institute

Novi, Michigan, 48374, United States

NOT YET RECRUITING

Mayo Foundation Rochester

Rochester, Minnesota, 55902, United States

NOT YET RECRUITING

Midwest Ear Institute

Kansas City, Missouri, 64111, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63108, United States

RECRUITING

NYU Langone Health

New York, New York, 10017, United States

NOT YET RECRUITING

University Hospitals Cleveland Medical Centre

Beachwood, Ohio, 44122, United States

NOT YET RECRUITING

Hearts for Hearing Foundation

Oklahoma City, Oklahoma, 73120, United States

NOT YET RECRUITING

University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84132, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Craig Buchman

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PRS Specialist

CONTACT

+61294286555; cltd-prs-admin@cochlear.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 17, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)