ATHENS, Ohio (PRWEB) March 24, 2015
Tinnitus sufferers in a clinical study of the first device to treat both tinnitus and hearing loss using complex, customizable sound therapy integrated with hearing aids are showing substantial improvement in their tinnitus symptoms, according to Sanuthera.
Sanuthera, which manufactures medical devices to treat tinnitus, will present interim results of its Cleveland Clinic study at AudiologyNOW!, the American Academy of Audiology’s annual conference, this week in San Antonio.
The study uses Sanuthera’s Serenity device, which integrates fully functioning hearing aids with complex, customizable sound therapy. Results shows that subjects experienced the highest level of treatment effect, and a 36 percent average improvement in their tinnitus symptoms, after six months, with a 62-point maximum improvement. 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.
“These study results are particularly significant in context of the ability for Sanuthera to deliver effective results to a large market,” says Jeff DiGiovanni, Ph.D., president of Sanuthera. Eighty-five percent of tinnitus sufferers also have an addressable hearing loss, according to DiGiovanni. “Sanuthera’s device, combining complex, customized sound with fully functioning hearing devices, offers better quality and greater convenience for millions of people,” he explains.
Serenity, Sanuthera’s flagship product, is 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, according to DiGiovanni. The company submitted its Serenity device to the U.S Food and Drug Administration for 510(k) clearance in December 2014.
The Sanuthera study, which began collecting data in early 2013, is ongoing. The Cleveland Clinic professionals conducting the study are Sharon Sandridge, Ph.D., director of clinical services in audiology, and co-director of the Tinnitus Management Clinic and Audiology Research Lab; and Craig Newman, section head of audiology, and professor in the Department of Surgery at the Cleveland Clinic Lerner College of Medicine.
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.