Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2024-09-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Tinnitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tinnitus Implant System

Intervention Type DEVICE

Device will deliver stimulation below hearing thresholds continuously or intermittently.

Interventions

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Tinnitus Implant System

Device will deliver stimulation below hearing thresholds continuously or intermittently.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No