Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Inclusion Criteria * Age: ≥18 years of age * Normal to moderate SNHL (≤70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥60% in the ear to be implanted * Asymmetric or unilateral subjective tonal tinnitus * Subjectively severe tinnitus present for at least 6 months, but not longer than 12 years; it is permissible to include people who have had intermittent or constant tinnitus longer than 12 years as long as it was not perceived as severe longer than 12 years * Tinnitus that is disruptive by at least two of the three criteria: THI in the severe range (≥56/100) TFI in the severe range (≥52/100) Tinnitus VAS-A or Tinnitus VAS-L ≥50/100 * Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking, when such interventions are potentially clinically indicated (e.g., it is not expected that people with minimal or no hearing loss would trial a conventional hearing aid) * MRI of the head that does not reveal any anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that would negatively impact response to study intervention (e.g., vestibular schwannoma) * Temporal bone CT that does not reveal any major anatomical or structural abnormalities that would negatively impact response to study intervention * Participants must be able to read, understand, and provide informed consent to participate in the trial * Participants must be willing and anticipate being able to return for study procedures…