Sanuthera Submits Serenity Device to FDA for 510(k) Clearance

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-- Ohio company manufactures tinnitus, hearing loss treatment device --

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Sanuthera, manufacturer of medical devices to treat tinnitus, has submitted its Serenity device to the U.S Food and Drug Administration for 510(k) clearance.

Serenity, the company’s flagship product, is the first device to treat both tinnitus and hearing loss, with 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

The submission of the Serenity device comes concurrently with Sanuthera’s ongoing 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 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.

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification, also called a PMN or 510(k).

Sanuthera (http://www.sanuthera.com)
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.
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Aimee Bennett
Sanuthera
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Rick Giancola