Research & Development Unit
510K Clinical Trial
Research & Develop Products and Services for the Global Epidemic of Hearing Loss
Global Health Crisis: 360 Million and growing with a form of Treatable Hearing Loss
The team of INND has been Researching and Developing products and solutions for the hearing impaired and the businesses that support the hearing impaired for more than 3 decades. The R&D which will comprised of a team of world renowned scientists, business professionals, and industry leaders, will rapidly develop and deploy products for the sole purpose of furthering INND agenda to further create a revenue eco-system, as well as offer the 360 million people in the world Hearing Solutions Not Just Hearing Aids.
Hearing Solutions Not Just Hearing Aids
Huge Untapped Market for Many Reasons
InnerScope Hearing Technologies will go above and beyond to find new products and services to offer the approx. 80% of the global population with Hearing Loss that still is not receiving treatments or solutions for their Hearing Loss. InnerScope Hearing Technologies is developing new products and services that will be deployed globally to help those 360 Million people in the world suffering from Hearing Loss.
InnerScope Hearing Technologies Inc. & Erchonia Corporation to Conduct FDA 510K Clinical Trial for the Treatment of Tinnitus
InnerScope and Erchonia Hearing Products, when cleared, will be the first FDA-Cleared treatment for relief of tinnitus.
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, hissing, whistling, swooshing, and clicking. Approximately 15% to 20% of the world's population suffers from tinnitus. Tinnitus can be a severely debilitating problem, and numerous risk factors have been associated with the development of tinnitus. Those with a hearing impairment have a higher risk for tinnitus, and the associated increase in risk is dependent on the severity of hearing impairment. Furthermore, there is an elevated risk of tinnitus in people with a history of head injury, depressive symptoms, target shooting, arthritis, use of NSAID medications, hypertension, and smoking. In addition, individuals with intolerable tinnitus often suffer from higher rates of anxiety, depression, low self-esteem, and poor quality of life compared to those without tinnitus.
According to the American Tinnitus Association (“ATA”) estimates nearly 50 million Americans experience some form of tinnitus and roughly 20 million people struggle with burdensome chronic tinnitus, while 2 million have extreme and debilitating cases. Underlying hearing loss occurs in 90% of all tinnitus sufferers.
Tinnitus is the number One Disability for Veterans. Tinnitus is the most common service related disability among veterans, with over 1.5 million American veterans receiving disability payments for intolerable tinnitus. 60% of veterans returning from Iraq & Afghanistan come home with hearing loss and tinnitus based on information from www.hearinghealthfoundaton.org. With tinnitus claims increasing at an annual rate of 15%, the total cost per year to the U.S. Department of Veterans Affairs for tinnitus related compensation to veterans is expected to have exceeded 3 billion dollars in 2017.
Currently, other than tinnitus maskers or tinnitus management devices that only ease the perceived burden of tinnitus, there is no scientifically validated cure or any FDA-Cleared treatments for temporary relief for most types of tinnitus. InnerScope and Erchonia Hearing Products, when cleared, will be the first FDA-Cleared treatment for relief of tinnitus.
InnerScope and Erchonia 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 offers a treatment protocol for relief of tinnitus symptoms. Both companies anticipate receiving the FDA-Clearance by the end of the third quarter of 2019. 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 U.S. Department of Veterans Affairs for using its hearing products for treating the millions of U.S. veterans that suffer from tinnitus.
Contact Us Today
InnerScope Hearing Technologies has a proven track record of disrupting well-established markets within the Unites States of America with our products and services within a matter of months not years, can go from newcomer in the market to Market Leader, turning the competition in the market irrelevant. InnerScope Hearing Technologies is now deploying our products and services on the Global stage to help the 360+ Million people around the world suffering from some form of Hearing Impairment in any & all situations.
Contact Us Today if you would like to use any of our innovative products and services