Sanuthera reports that the clearance allows the company to market its Serenity 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 is Sanuthera’s flagship product, a device that treats both tinnitus and hearing loss using customizable, complex sound therapy integrated with fully functional hearing aids. The device combines complex, customized sound and amplification in one ear-level device, and is intended to deliver sound therapy through a patient’s existing hearing aid, plugging into the audio port of the aid’s streamer. The company says the Serenity can be adapted for use with any manufacturer’s hearing aid system.
Programmed by a hearing 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, according to Sanuthera.
The FDA clearance comes as Sanuthera concludes a 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. To indicate results, the study uses the Tinnitus Handicap Inventory (THI), a self-report tinnitus handicap measure that quantifies the impact of tinnitus on daily living. In the Cleveland Clinic study, the THI has shown a 36% improvement at 6 months, with a 62-point maximum improvement.
Image credit: Sanuthera