Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
- Conditions
- Tinnitus
- Interventions
- Device: Erchonia® THL™Device: Placebo Laser
- Registration Number
- NCT05374421
- Lead Sponsor
- Erchonia Corporation
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Erchonia® THL™ Erchonia® THL™ The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device. Placebo Laser Placebo Laser The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI) Baseline and 4 weeks The Tinnitus Functional Index (TFI) has been highly recommended to be used in both clinical and research settings for tinnitus measurement (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. The calculation of overall TFI score is as follows: (1) Sum all valid answers. (2) Divide by the number of questions for which the sum of the valid answers was based to yield the respondent's mean item score. (3) Multiply by 10 to attain the respondent's overall TFI score (0-100 range). Total TFI score can be categorized as Level of Tinnitus Severity as follows: 0 to 17: Not a problem,18 to 31: Small problem, 32 to 53: Moderate problem, 54 to 72: Big Problem, 73 to 100: Very big problem.
A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Valley Audiology
🇺🇸Concord, California, United States