Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms

Study Overview
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Brief Summary
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This study is to see if applying red low-level laser light can help to reduce tinnitus symptoms

Detailed Description
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The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing temporary relief of tinnitus symptoms in adults 18 years and older.

Official Title
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Erchonia and InnerScope, Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Erchonia HLS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjective tinnitus Tonal tinnitus. Constant tinnitus on-going at least half the time over at least the past 6 months. Willing to abstain from other tinnitus-related treatments except prior hearing aid use throughout the study duration. Willing and able to refrain from activities or work involving excessive noise exposure without the use of effective hearing protection throughout study participation. 18 years of age or older Primary language is English Exclusion Criteria: Objective tinnitus Atonal, pulsatile, intermittent, or occasional tinnitus Severe or profound hearing loss in one or both ears Current or prior surgically removed acoustic neuroma Consistent use of any of the following drugs known to cause or increase tinnitus (primarily ototoxins) within the past 30 days: NSAIDS (motrin, naproxen, relafen, etc) aspirin (exceeding 300mg per day) and other salicylates Lasix and other loop diuretics mycin antibiotics such as vancomycin quinine and related drugs Chemotherapy agents such as cis-platin Acute or chronic vertigo/dizziness Ménière's disease Prior stapendectomy Prior mastoidectomy Auditory nerve tumor (acoustic neuroma), current or surgically removed in the past Active infection/wound/external trauma to the areas to be treated with the laser Medical, physical or other contraindications for, or sensitivity to, light therapy Pregnant, breast feeding, or planning pregnancy prior to the end of study participation Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erchonia HLS<br>635 nanometers (nm) laser application | Device: Erchonia HLS<br>* 56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Score on the Tinnitus Handicap Inventory (THI). | The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire to assess how tinnitus affects an individual's life. Each question is responded to as 'yes' (4 points); 'sometimes' (2 points) or 'no' (0 points). The individual scores for the 25 questions are added to get a total THI score from 0 to 100. The higher the total THI score, the greater the negative impact tinnitus has on the individual's life. Change in total THI score is calculated as total THI score after the eight week procedure administration phase minus total THI score at baseline. A positive (+) change in total THI score indicates the negative impact of tinnitus on the individual's everyday life has worsened. A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened). | Baseline and 8 week |