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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCochlear

About this trial

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 criteria

Qualifiers

18 years or older.

Normal hearing to moderately severe sensorineural hearing loss defined as a pure tone average (PTA) at 500, 1000, 2000 and 4000 Hz less than 65 dB HL in both ears (separately) and best-aided phoneme recognition score more than or equal to 80% in both ears (separately).

Unilateral or asymmetric subjective (no pulsatile) tinnitus. In case of asymmetric tinnitus, the worst ear must be implanted.

Tinnitus duration of at least 6 months.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Tinnitus Implant System

Treatment groups

16 Participants
are divided into 1 treatment group

Locations

2
Belgium
Antwerp University Hospital (UZA)B-2650, EdegemBelgium, Belgium
Netherlands
University Medical Center Utrecht3508, Utrecht Netherlands

Sponsors and collaborators

Cochlear

Lead sponsor