Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Matthew L. Carlson, M.D.

Status: Completed

Conditions: Tinnitus

Treatments: Device: Tinnitus Implant System

Study type: Interventional

Funder types: Other

Identifiers

NCT03988699

18-007120

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 and follow up visits
• Participants must have completed participation in the study entitled "Cochlear Promontory Stimulation for Treatment of Tinnitus: Towards Developing an Implantable Device" (IRB 17-004832) at Mayo Clinic

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Subject with severe tinnitus

Experimental group

Description:

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.

Treatment:

Device: Tinnitus Implant System