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InnerScope Hearing Technologies Inc. & Erchonia Corporation to Conduct FDA Clinical Trial for the Treatment of Tinnitus
InnerScope Hearing Technologies Inc. & Erchonia Corporation to Conduct FDA Clinical Trial for the Treatment of Tinnitus.
About this update from Innerscope Hearing Technologies, Inc.
[{"type":"text","content":"\nInnerScope and Erchonia have entered into Joint Development & Exclusive Distribution Agreements and intend to obtain a 510k FDA-Clearance via clinical trial to study the effect on using Erchonia's Low-Level Laser Therapy Technology for the relief of tinnitus symptoms\n\n \n \n \n \n \n \n \n \n \n \n \n EL PR Nov. 1\n \n \n \n \n \n \n \n \n\n ROSEVILLE, Calif., Nov. 01, 2018 (GLOBE NEWSWIRE) -- via OTC PR WIRE --  InnerScope Hearing Technologies Inc. (OTCQB: INND) has entered into a Joint Development Agreement (the \"JD Agreement\") and an Exclusive Distribution Agreement (the \"ED Agreement\") with Erchonia Corporation (\"Erchonia\"), a world leader 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 510k FDA-Clearances for devices, technologies, methods and techniques (\"Hearing Products\") 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 (\"Hearing Disorders\"). 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. InnerScope and Erchonia 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 in Walnut Creek, California. The IRB also approved InnerScope's Director of Audiology, Dr. Kathy L. Amos, Au.D. Doctor of Audiology, as the Principal Investigator for the trial. Tinnitus is the perception of sound when no actual external noise is present. While it is commonly referred to as \"ringing in the ears,\" tinnitus can manifest many different perceptions of sound, including buzzing, his...