Sanuthera, Athens, Ohio, a manufacturer that specializes in medical devices to treat tinnitus, has announced that it submitted its Serenity tinnitus device to the US Food and Drug Administration (FDA) for 510(k) clearance. Serenity, the company’s flagship product, is said to be the first device to treat both tinnitus and hearing loss, with customizable, complex sound therapy integrated with fully functional hearing aids.
According to Sanuthera, the Serenity device combines complex, customized sound and amplification in one ear-level device, to deliver 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 for FDA 510(k) clearance, the company says, has been coordinated with its ongoing clinical study at the Cleveland Clinic. In the study, more than 85% of tinnitus sufferers using the Serenity device have shown improvement at 1, 3, and 6 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% improvement at 6 months, with a 62-point maximum improvement.
“Sanuthera’s technology is simple, unique and effective, delivering results to a large market,” says Jeff DiGiovanni, PhD, president of Sanuthera. “Eighty-five percent of tinnitus sufferers who seek medical treatment have concurrent hearing loss. The combination of complex, customized sound with a hearing device that Sanuthera’s technology offers greatly improves upon the quality and convenience of other tinnitus treatments, which only offer these components separately.”
Sanuthera reports that under Section 510(k) of the Food, Drug and Cosmetic Act, device manufacturers must register and notify the 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).
Image credit: Sanuthera