Athens, OH (PRWEB) August 12, 2015
Sanuthera, manufacturer of medical devices to treat tinnitus, has received 510(k) clearance from the U.S. Food and Drug Administration for its Serenity device.
The clearance allows Sanuthera to market its tinnitus treatment device, subject to the general controls provisions of the Federal Food, Drug and Cosmetic Act. Provisions include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Serenity, Sanuthera’s flagship product, is the first device to treat both tinnitus and hearing loss, using customizable, complex sound therapy integrated with fully functional hearing aids. As the only device to combine the gold standard of complex, customized sound and amplification in one ear-level device, the Serenity delivers sound therapy through a patient’s existing hearing aid, plugging into the audio port of the aid’s streamer. The Serenity can be adapted for use with any manufacturer’s hearing aid system.
Programmed by a hearing health care professional familiar with diagnosis and management of tinnitus, the Serenity works as part of a personalized tinnitus management program to provide temporary relief from tinnitus symptoms. The product is designed primarily for adults 18 years of age and older.
The FDA clearance comes as Sanuthera concludes a clinical study at the Cleveland Clinic. In the study, more than 85 percent of tinnitus sufferers using the Serenity device have shown improvement at one, three and six months. The study uses the Tinnitus Handicap Inventory (THI), a self-report tinnitus handicap measure that quantifies the impact of tinnitus on daily living, to indicate results. In the Cleveland Clinic study, the THI has shown a 36 percent improvement at six months, with a 62-point maximum improvement.
“Sanuthera’s technology is simple, unique and effective, delivering results to a large market,” says Jeff DiGiovanni, Ph.D., president and co-founder of Sanuthera. Eighty-five percent of tinnitus sufferers who seek medical treatment have concurrent hearing loss. “The combination of complex, customized sound and hearing device that Sanuthera’s technology offers greatly improves upon the quality and convenience of other tinnitus treatments, which only offer these components separately,” he explains.
Sanuthera manufactures clinically proven medical devices to treat tinnitus. The company’s flagship product, Serenity, is the first device to treat both tinnitus and hearing loss, with fully customizable, complex sound therapy integrated with fully functional hearing aids. Incorporated in 2011, Sanuthera is based in Athens, Ohio. The company receives support from TechGROWTH Ohio, which is funded by an Ohio Third Frontier grant, with support from Ohio University and private capital.