A Prospective, Multicentric, Feasibility Investigation to Assess the Effect of the Tinnitus Implant on Tinnitus Loudness in Adults With Moderate to Severe Chronic Tinnitus Accompanied by Normal Hearing to Moderately Severe Hearing Loss.

Cochlear2 sites in 2 countries16 target enrollmentJune 16, 2025

ConditionsTinnitus Hearing Loss, Bilateral or Unilateral Normal Hearing

Overview

Phase: N/A
Intervention: Not specified
Conditions: Tinnitus
Sponsor: Cochlear
Enrollment: 16
Locations: 2
Primary Endpoint: Mean change in tinnitus loudness from baseline to 6 months post-activation of the Tinnitus Implant System
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.

Registry

clinicaltrials.gov

Start Date

June 16, 2025

End Date

April 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Pulsatile tinnitus.
•Any anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that would negatively impact response to study intervention (determined in a temporal bone CT and if necessary (e.g. possibility of vestibular/acoustic schwannoma) by a MRI scan of the head (of sufficient quality at the discretion of the investigator) not more than five years old at the time of enrolment
•Medical contraindications limiting correct placement, activation, or treatment (determined by medical history; contraindications include brain or major ear surgery, brain or temporal bone tumor(s), recurrent ear infections within the last year, otosclerosis, prior major head trauma that results in sudden injury that causes damage to the brain and results in lasting cognitive impairment).
•Any medical condition, including mental illness or substance abuse, deemed by the Investigator to likely interfere with a patient's ability to sign informed consent, cooperate and/or participate in the study, or interfere with the interpretation of the results (incl. pregnant or breastfeeding women or patients with unrealistic expectations).
•Presence of clinically diagnosed depression or anxiety determined by a psychological state evaluation (if PHQ-9 \> 9 or GAD-7 \> 9).
•Active (currently or within two months prior to enrolment) use of medications (taking regularly scheduled antidepressant, anxiolytic, antipsychotic or antiepileptic medications, or other neuromodulator agents) or other tinnitus treatments.
•It is permissible to include people who use such medications at lower doses as a sleep aid or for people who intermittently use such medications for situational anxiety (e.g., Ativan before airplane travel). A change in medication during the trial should be avoided.
•It is permissible to include people who prefer to use a hearing aid to amplify ipsilateral hearing loss. The start of using a hearing aid during the trial should be avoided.
•Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
•Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.

Outcomes

Primary Outcomes

Mean change in tinnitus loudness from baseline to 6 months post-activation of the Tinnitus Implant System

Time Frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation

Self-reported tinnitus loudness as measured on the Visual Analogue Scale-Loudness (VAS-L) where 0 is equivalent to absence of tinnitus and 100 indicates tinnitus of the greatest loudness severity

Secondary Outcomes

Reported device or procedure related adverse events and harms(Pre-operative baseline to 6 months post Tinnitus Implant System activation)
Mean change in tinnitus annoyance from baseline to 6 months post activation of the Tinnitus Implant System(Pre-operative baseline to 6 months post Tinnitus Implant System activation)
Mean change in tinnitus perception from baseline to 6 months post activation of the Tinnitus Implant System(Pre-operative baseline to 6 months post Tinnitus Implant System activation)
Change in self-reported matches of tinnitus pitch and loudness to acoustic stimuli(Pre-operative baseline, activation (Implant activation is approximately 10 weeks after surgical implantation of Tinnitus implant), 3 months post activation, 6 months post activation)
Mean change in health-related quality of life with Tinnitus Implant System(6 months post Tinnitus Implant System activation)
Mean change in health status with Tinnitus Implant System(At 6 months post Tinnitus Implant System activation)
Mean change in speech perception in quiet from baseline to 6 months post-activation(Pre-operative baseline to 6 months post Tinnitus Implant System activation)
Mean change in hearing thresholds from baseline to 6 months post-activation(Pre-operative baseline to 6 months post Tinnitus Implant System activation)