Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Matthew L. Carlson, M.D.

Status: Active, not recruiting

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 ≥ 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

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