Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Study Overview
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Brief Summary
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Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus.

Detailed Description
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This study requires one year of participation with at least 21 visits to Mayo Clinic in Rochester MN for device programming and audiometric testing. The device is implanted during an outpatient surgery. Participants may keep the study device after participation is complete.

Official Title
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Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Tinnitus Implant System


Participation Criteria
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Eligibility Criteria
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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 ≥ 75%. Unilateral or asymmetrical subjective tonal tinnitus Tinnitus present for at least 6 months, but not longer than 3 years Tinnitus that is disruptive THI score in the severe range (≥56/100) TFI score in the severe range (≥52/100) Tinnitus VAS ≥50/100 Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking Exclusion Criteria Age: <18 years of age Tinnitus present less than 6 months or longer than 3 years Current pregnancy History of brain or major ear surgery Prior major head trauma Presence of clinically significant depressive or anxiety symptoms determined by screening using the GAD-7, PHQ-8, and SHAI GAD-7 >9 (indicates clinically significant anxiety) PHQ-8 >9 (indicates clinically significant depression) SHAI >25 (hypochondriacal level illness anxiety) Inability to assess, continue or complete trial Currently on antidepressants, anxiolytics or antipsychotics Active use of other tinnitus treatments (not including non-masking hearing aid use) Normal contrast-enhanced MRI of the head Normal temporal bone CT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject with severe tinnitus<br>Subjects diagnosed with severe tinnitus for at least six months, and it has not responded to conventional management will have surgical implantation of the device Tinnitus Implant System. | Device: Tinnitus Implant System<br>* Device will deliver stimulation below hearing thresholds continuously or intermittently.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with treatment-related adverse events | Measured by subjects meeting one or more of the following criteria: worsening bone conduction thresholds in any tested frequency (0.25, 0.5, 1, 1.5, 2, 3, or 4 kHz) from baseline by a clinically significant amount (>10 dB) or worsening in WRS from baseline by a clinically significant amount (>20%) or worsening in video head impulse test result from baseline or one or more serious AEs | One year | 
| Number of subjects to experience significant improvement from implantation of the device | Measured by subjects meeting at least two of three measurements of tinnitus severity: Tinnitus Handicap Inventory (THI) improvement by greater than 7 points using a 25-item self-assessment questionnaire with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points) or Tinnitus Functional Index (TFI) improvement by greater than 13 points using a 25-item self-report questionnaire on a scale of 0 to 10 with a maximum possible score of 250 or Tinnitus visual analog scale improvement by greater than 15 points using a self-reported scale consisting of a 10 cm line with verbal descriptors (word anchors) at each end to express the extremes of the symptom; 0 mm designates no pain and 100 mm designates the greatest imaginable severity of pain. | Baseline, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 52 weeks |