Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

NCT03988699 | Completed FDA Device

• 1 other identifier: 18-007120
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Subject with severe tinnitus

EXPERIMENTAL

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

Interventions

Tinnitus Implant System DEVICE

Device will deliver stimulation below hearing thresholds continuously or intermittently.

Subject with severe tinnitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matthew L. Carlson, M.D.: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew L Carlson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 17, 2019
• Study Start: August 23, 2021
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)