Evaluating a Tinnitus Implant for Chronic Tinnitus Relief

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.

This study is testing a new implant for adults with chronic tinnitus to see if it can help reduce their symptoms and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cochlear (Industry-sponsored)
• Locations: 2 sites (Edegem, Belgium and 1 other locations)
• Trial ID: NCT06641999 on ClinicalTrials.gov

What this trial studies

This study tests an experimental Tinnitus Implant System designed to alleviate chronic tinnitus in adults with varying levels of hearing loss. The implant, surgically placed behind the ear, stimulates the auditory nerve through electrical signals. Participants will undergo evaluations of tinnitus loudness and annoyance, along with self-reported questionnaires regarding their tinnitus and overall health. The goal is to assess the effectiveness of the implant in reducing tinnitus symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe chronic tinnitus and normal to moderately severe hearing loss.

Not a fit: Patients with mild tinnitus or those whose tinnitus has responded satisfactorily to standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this implant could significantly reduce tinnitus loudness and improve quality of life for patients suffering from chronic tinnitus.

How similar studies have performed: While there have been studies on cochlear implants for hearing loss, this specific approach for tinnitus is novel and has not been extensively tested.

Eligibility criteria

Inclusion criteria

* 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.
* Severe tinnitus loudness determined by a. VAS-L score in the severe range i.e. 50-100/100 b. TFI score in the severe range i.e. 52-90/100
* Tinnitus that is intractable and has not been ameliorated satisfactorily by standard of care such as CBT or hearing aid, when such interventions are potentially clinically indicated.
* Clinically significant reduction in VAS-L score (≥ 15/100 points) in response to trans-tympanic promontory stimulation
* Willing and able to provide written informed consent.
* Medically able to use the device and to undergo general anaesthesia for implantation taking into account their medical condition, contraindications and surgical risks.
* Dutch language proficiency

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.
* Current participation, or participation in another interventional clinical study/trial in the past 60 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Where this trial is running

Edegem, Belgium and 1 other locations

• Antwerp University Hospital (UZA) — Edegem, Belgium, Belgium (Recruiting)
• University Medical Center Utrecht — Utrecht, Netherlands (Recruiting)

Study contacts

• Study coordinator: Remo Arts

Conditions Tinnitus; Hearing Loss, Bilateral or Unilateral; Normal Hearing; tinnitus; cochlear implant