The Levo System has been cleared by the FDA for sales in the U.S. and is cleared for sale in Canada and Europe through CE Mark.
Randomized Clinical Trial Results Offers Hope to People Who Suffer from Ringing in the Ears |
| [08-December-2017] |
| PORTLAND, Ore., Dec. 8, 2017 /PRNewswire/ -- As many as 50 million Americans suffer from tinnitus, a debilitating health condition commonly known as “ringing in the ears.” Musicians, factory workers, military veterans and many others endure its effects, including problems with concentration, sleep, anxiety and depression. Many who experience chronic tinnitus turn to sound devices or machines that “mask” their ringing with white noise. But masking typically offers only short-term relief to those who struggle with the perception of buzzing, hissing, whistling or clicking and do not reduce the level of tinnitus intensity. New technology is taking a radically different approach by retraining the brain to ignore these types of sounds, showing the potential to alleviate the condition altogether. The Levo System, an FDA-cleared medical device, mimics the specific sound of a patient’s individual tinnitus. The patient listens to this Sound Match nightly through custom-fit ear buds while sleeping. Over time the brain naturally learns to ignore the tinnitus sound, diminishing its impact and intensity, to improve quality of life. A recently released randomized study by the National Center for Rehabilitative Auditory Research at the VA Portland Health Care System demonstrated that therapy with the Levo System Sound Match showed greater reduction in tinnitus intensity than a traditional masker, long considered the standard of care for treating tinnitus. The study was led by James Henry, PhD, globally recognized for his innovative work in treating and managing tinnitus. Study participants were randomly assigned to one of three groups: the Levo System with Sound Match, the Levo System without a match or the traditional masker, a bedside sound generator. Patients who received Sound Match therapy reported the greatest reduction in tinnitus intensity as well as statistically significant improvement in key quality of life measures including improved sleep and cognitive function. Seth Weible, AuD, a Levo provider at NYC Hearing Associates in Manhattan, has had success using the Levo System. “No other system available today is creating quality of life improvement like the Levo System,” Weible said. “Patients experience tremendous relief.” Tinnitus affects a range of people, including those who are exposed to continuous noise. It is the leading service-related disability among U.S. veterans, according to the American Tinnitus Association. “It is gratifying to see so many people experience relief from a condition that has defied a long-term solution,” said Michael Baker, president and CEO of Otoharmonics, which produces the Levo System. “Patients report the greatest improvement when they drive decisions about their treatment.” The Levo System has been cleared by the Food and Drug Administration for sales in the U.S. and is cleared for sale in Canada and Europe through CE Mark. V.A. Study http://AJA.pubs.asha.org/article.aspx?doi=10.1044/2017_AJA-17-0022 About Otoharmonics Corporation Otoharmonics and Levo are registered trademarks of Otoharmonics Corporation. Contact: View original content with multimedia:http://www.prnewswire.com/news-releases/levo-tinnitus-system-shown-to-have-better-outcomes-than-current-standard-of-care-300568826.html SOURCE Otoharmonics |
