Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Exclusion Criteria

• •Age: \<18 years of age
• •Subjectively severe tinnitus present less than 6 months or 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
• •History of brain or major ear surgery
• •History of brain or temporal bone tumor(s)
• •Recurrent ear infections within the last year
• •Prior major head trauma, defined for the purposes of this study as head trauma that results in sudden injury that causes damage to the brain and results in lasting cognitive impairment
• •Ongoing clinical diagnosis of depression or anxiety; for the purposes of this study, it is permissible to include people who: 1. have a past history of clinically diagnosed depression or anxiety that is no longer currently active; or 2. people who have depressive or anxious symptoms that are thought to primarily result from severe tinnitus
• •Presence of clinically significant depressive or anxiety symptoms determined by screening using the GAD-7, PHQ-8, and SHIA questionnaires GAD-7 score \>9 (indicates clinically significant anxiety) PHQ-8 score \>9 (indicates clinically significant depression) SHAI score \>25 (hypochondriacal level illness anxiety)
• •Currently taking regularly scheduled antidepressant, anxiolytic, antipsychotic or antiepileptic medications, or other neuromodulatory agents; for this study, 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)
• •Active use of other tinnitus treatments; for the purposes of this study it is permissible to include people who prefer to use a hearing aid to amplify ipsilateral hearing loss
• •Known pregnancy at time of surgery
• •Any medical condition, including mental illness or substance abuse, deemed by the PI to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.