Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms

Study Overview
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Brief Summary
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The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by individuals in their own homes.

Detailed Description
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Human Factors Validation Testing will initially be conducted to valuate a lay person's ability to understand and apply as applicable the information contained in the THL™ Use Device Proper Use Reference Guide, and device packaging and labeling materials to correctly, safely, and successfully activate and operate the THL™ to administer the treatment; and to identify any and all use difficulties, problems and errors, including those pertaining to critical tasks and close calls demonstrated by the lay person during device operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification, as applicable Phase Two will commence following the successful completion of Phase One. Phase Two comprises the performance of a double-blind, randomized, placebo-controlled, clinical study of the efficacy of the Erchonia® THL™, manufactured by Erchonia Corporation (the Sponsor), for prescription home use application in providing relief of tinnitus symptoms when used by individuals in their own homes.

Official Title
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Clinical Efficacy and Human Factors Validation Testing for Prescription Home Use of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Erchonia® THL™
* Device: Placebo Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral tinnitus Current diagnosis of subjective tinnitus No hearing loss or sensorineural hearing loss only 18 years of age or older Able to read and write English Constant tinnitus on-going over at least the past 6 months Willing to abstain from other tinnitus-related treatments, except existing hearing aid use, throughout the study duration. Tinnitus Functional Index (TFI) total score of 32 to 72 (Moderate to Big Problem) Degree of hearing loss is less than 60 dB (Moderate or less) Exclusion Criteria: Tympanosclerosis Meniere's disease Acoustic neuromas Current and consistent use of ototoxic medications Presbycusis Thyroid disease Skull fracture Traumatic brain injury (TBI) Depression Syphilis Retrocochlear tumors Conductive hearing loss Pregnant, think they might be pregnant, or breastfeeding. Open wounds (sores, cuts, ulcers, etc) around ears or neck Cancerous growths around ears or neck Difficulty with hand dexterity sufficient to impact the ability to administer treatments with the laser such as from severe arthritis in the hands, Multiple Sclerosis, -Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erchonia® THL™<br>The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device. | Device: Erchonia® THL™<br>* The Erchonia® THL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device. The diodes are positioned approximately 4 inches from the skin and applied in a continuous back and forth sweeping motion from the top of the ear down the side of the neck. The treatments will be self-administered by the subject at his or her's place of residence, once per day for 28 days. Each procedure administration lasts 5 minutes per ear, for a total of 10 minutes.<br>|
| Placebo Comparator: Placebo Laser<br>The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light. | Device: Placebo Laser<br>* The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light. The diodes are positioned approximately 4 inches from the skin and applied in a continuous back and forth sweeping motion from the top of the ear down the side of the neck. The treatments will be self-administered by the subject at his or her's place of residence, once per day for 28 days. Each procedure administration lasts 5 minutes per ear, for a total of 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index (TFI) | The Tinnitus Functional Index (TFI) has been highly recommended to be used in both clinical and research settings for tinnitus measurement due to its responsiveness to treatment-related change, validity for scaling the overall severity of tinnitus, and comprehensive coverage of multiple domains of tinnitus severity (Meikle et al., 2011). The self-report questionnaire, consists of 25 items with a response option on an 11-point Likert scale from 0-10 | Basline and 4 weeks |