Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
Tinnitus
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
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.
Sites / Locations
- Valley Audiology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Erchonia® THL™
Placebo Laser
The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device.
The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light.