RecruitingNot ApplicableNCT06641999

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

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.


Sponsor

Cochlear

Enrollment

16 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Tinnitus Implant System for people with hearing loss, bilateral or unilateral, normal hearing, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETinnitus Implant System

Implanted with Tinnitus Implant System: Active Implantable Medical Device


Locations(2)

Antwerp University Hospital (UZA)

Edegem, Belgium, Belgium

University Medical Center Utrecht

Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06641999


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