InnerScope Hearing Technologies (Roseville, CA) has entered into joint development and exclusive distribution agreements with low-level laser therapy technology developer and maker Erchonia (Melbourne, FL). The two companies will conduct U.S. FDA clinical research and trials for the purpose of obtaining FDA clearances for devices, technologies, methods, and techniques used in the treatment of hearing-related conditions and disorders, including tinnitus, sensorineural hearing loss, central auditory processing disorders, dizziness, vertigo, balance disorders, and Meniere's disease.
Both agreements give InnerScope the exclusive worldwide rights for all designs and any newly developed Erchonia 3LT lasers, related technologies, and methods to be used to treat hearing disorders. The exclusive distribution agreement will also give the company the exclusive rights and license to commercially distribute such hearing products worldwide.
The two companies have received approval under FDA regulations from a Institutional Review Board (IRB) for the initial clinical trial of the effect of Erchonia's low-level laser therapy technology on the relief of tinnitus symptoms. The approved initial clinical trial site will be InnerScope's Value Audiology and Hearing Aid Center (Walnut Creek, CA). The IRB also approved InnerScope's Director of Audiology, Kathy L. Amos, Au.D., as the principal investigator for the trial.
Currently, other than tinnitus maskers or tinnitus management devices that only ease the perceived burden of tinnitus, there is no known scientifically validated cure or any FDA-cleared treatments for temporary relief for most types of tinnitus. InnerScope and Erchonia Hearing Products, when cleared, will reportedly be the first FDA-Cleared treatment for relief of tinnitus.
Both companies anticipate receiving the FDA clearance by the end of the third quarter of 2019. InnerScope plans to introduce and commercially market and distribute the tinnitus hearing products to the audiological global market as early as December 2019. In addition, InnerScope plans on working with U.S. Department of Veterans Affairs for using its hearing products for treating the millions of U.S. veterans that suffer from tinnitus.