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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Tinnitus
• Intervention / Treatment: Device: Tinnitus Implant System

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subject with severe tinnitus; 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; Device will deliver stimulation below hearing thresholds continuously or intermittently.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Matthew L. Carlson, M.D.
• Investigators: Principal Investigator: Matthew L Carlson, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 18-007120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes