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

Launched by COCHLEAR · Oct 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of device called a Tinnitus Implant, which is designed to help adults who experience chronic tinnitus—a condition that causes ringing or buzzing in the ears. The implant is surgically placed under the skin behind the ear and sends electrical signals to the auditory nerve to help reduce the loudness of tinnitus. The study will involve adults aged 18 and older who have moderate to severe tinnitus and varying levels of hearing loss. Participants will need to have had tinnitus for at least six months and have not found relief from standard treatments like counseling or hearing aids.

If you decide to take part in this study, you will undergo various tests to assess how loud your tinnitus is and how much it bothers you. You'll also fill out questionnaires about your tinnitus and overall health. It's important to know that this study is not yet recruiting participants, and eligibility will depend on specific medical criteria, such as your hearing ability and health history. If you're interested or think you might qualify, you’ll need to discuss this with your healthcare provider.

Gender

ALL

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).