Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

14 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Individuals aged 18 years and older at time of consent.
• Meets local candidacy criteria for cochlear implantation in the ear to be implanted.
• Failure to satisfactorily treat tinnitus with conventional treatments including Tinnitus Retraining Therapy (TRT) for at least six (6) months as determined by the investigator.
• Moderate to severe tinnitus handicap as determined by \>38 THI score (Grade 3 / Moderate or greater).
• Duration of moderate to severe tinnitus \< 3 years, 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 (i.e. Spanish).
• Direct access to a compatible Smart Phone.
• Willing and able to provide written informed consent.

Exclusion Criteria:

• Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.

Participants who meet any of the exclusion criteria described below will not be eligible for this clinical investigation.

• Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
• Tinnitus of central origin, pulsatile tinnitus related to blood flow, paroxysmal tinnitus, somatosensory tinnitus, tinnitus related to vertigo or headache, or post-traumatic tinnitus, 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 15 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 participant's participation or safety during the clinical investigation.
• Pregnant women.
• Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as spouse, parent, child or sibling.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of the investigation.
• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device that is different from the device in this study.
• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Cochlear

Study start

2027-02 Estimated

Primary completion

2028-04 Estimated

Study completion

2028-04 Estimated

First posted

Oct 26, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts