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

NCT07139327 | Active Not Recruiting DMC

• 1 other identifier: CLTD5864
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 8

Brief 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

Keywords

cochlear implant; sensorineural hearing loss

Outcome Measures

Primary Outcomes (2)

• Speech recognition performance in quiet

  Percent correct word score from preimplantation to post-activation

  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 (8)

• Speech recognition in quiet and noise

  Preimplantation to 12 months post-activation

• Speech Spatial Qualities questionnaire (SSQ-12)

  Preimplantation to 12 months post-activation

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

  Preimplantation to 12-months post-activation

• Health Utilities Index (HUI 2/3)

  Preimplantation to 12 months post-activation

• Living with Cochlear Implants Questionnaire (LivCI)

  Preimplantation to 12 months post-activation

Study Arms (1)

TICI G2 Clinical Investigation System

EXPERIMENTAL

Participants will be implanted with the TICI G2 Implant

Device: Cochlear Implant

Interventions

Cochlear Implant DEVICE

TICI G2 Clinical Investigation System

TICI G2 Clinical Investigation 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 post-linguistic moderately severe to profound sensorineural hearing loss (PTA4 of \>55 dB HL), in the ear to be implanted.
• Meets local candidacy criteria for cochlear implantation.
• Compromised functional hearing with a hearing aid in the ear to be implanted, as determined by the investigator.
• Willing to undergo unilateral cochlear implantation.
• 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.
• Cochlear ossification, cochlear 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.
• Preexisting skin condition that could jeopardize wound healing, as determined 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 subject's participation or safety during the clinical investigation.
• Women who are pregnant.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (8)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Macquarie University Hospital

Macquarie, New South Wales, 2109, Australia

Location

Westmead Private Hospital

Westmead, New South Wales, 2145, Australia

Location

Westmead Public Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Victoria Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

Location

St Vincent's Private Hospital

East Melbourne, Victoria, 3002, Australia

Location

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, 38700, France

Location

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural

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 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: August 17, 2025
• First Posted: August 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); AU (6)