InnerScope Hearing Technologies Inc announced that it has entered into a Joint Development Agreement (the “JD Agreement”) and an Exclusive Distribution Agreement (the “ED Agreement”) with Erchonia Corporation (“Erchonia”), a company involved in the manufacturing and development of Low-level Laser Therapy Technology (“3LT”) and medical laser equipment using 3LT technology. As part of the JD Agreement, InnerScope and Erchonia will conduct FDA Clinical Research and Trials for the purpose of obtaining 510(k) 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 (CAPD), dizziness, vertigo, balance disorders, and Meniere’s disease (“hearing disorders”). According to the company, both the JD and ED Agreements gives 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. Additionally, the ED Agreement will give InnerScope the exclusive rights and license to commercially distribute such hearing products worldwide.
According to the announcement, InnerScope and Erchonia have received approval under FDA regulations from an 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 in Walnut Creek, Calif. The IRB also approved InnerScope’s Director of Audiology, Kathy L. Amos, AuD, as the principal investigator for the trial.
InnerScope and Erchonia said they expect to be the “first to receive a 510k FDA Clearance” for their hearing products that are not considered tinnitus “maskers” and/or tinnitus management devices, but offer a treatment protocol for relief of tinnitus symptoms. Both companies anticipate receiving the FDA Clearance by the end of the third quarter of 2019, according to the announcement. InnerScope plans to introduce (depending upon when the 510k FDA Clearance happens) 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 the US Department of Veterans Affairs for using its hearing products for treating veterans that suffer from tinnitus.
“Erchonia is the world leader in furthering research and development of its Low-level Laser Technology for multiple medical laser applications,” said Steve Shanks, president of Erchonia Corporation. “I would like to thank Mark Moore, InnerScope’s Chairman, for contacting us a few years back introducing Erchonia to new medical applications using Erchonia’s 3LT Technology for treating hearing disorders. Erchonia has had the pleasure of working with Mark and Matthew Moore in developing treatment protocols using Erchonia’s 3LT Technology for treating multiple hearing disorders. We look forward to many Erchonia and InnerScope FDA-cleared devices for treating hearing disorders in the near future.”
Source: InnerScope, Erchonia