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Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus | Clinical Trials | Clareo Health

COMPLETEDNA

Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

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

NCT03988699•Matthew L. Carlson, M.D.

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

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
+2 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

August 23, 2021

Primary Completion Date

September 10, 2024

Completion Date

September 10, 2024

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

Tinnitus

Interventions

Tinnitus Implant System

DEVICE

Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus

NCT07393880

Tinnitus, SubjectiveTinnitus+1 more

View study

RECRUITINGNA

Noninvasive Therapy for Tinnitus

NCT07071480

TinnitusTinnitus, Subjective

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Inclusion Criteria

Exclusion Criteria

Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus

Noninvasive Therapy for Tinnitus

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

Treatment for PTSD and Tinnitus

Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia

Somatic Tracking for Tinnitus