Otoharmonics Receives FDA 510(k) Clearance for the Levo® System
PORTLAND, Ore., Sept. 3, 2014 /PRNewswire/ -- For use in temporarily relieving the symptoms of tinnitus, the Levo System is a personalized, neuroscience-based sound therapy. Leveraging the brain's natural cognitive abilities, Levo identifies and maps an individual's unique sound print using custom-fit ear buds and proprietary software on Apple iPad® and iPod® touch mobile digital devices.
Often described as 'ringing in the ears', tinnitus is a result of false signaling in the brain due to inner ear cell damage. Most commonly caused by exposure to loud noise and/or hearing loss, it can have a profound impact on a person's quality of life.
According to the American Tinnitus Association, an estimated 50 million people in the United States experience tinnitus to some degree. While it's only a minor annoyance for some, for 2-3 million it's completely debilitating, causing serious problems such as sleep loss, emotional distress and anxiety.
From the start, the Levo System was developed with the wellbeing of patients in mind. The team at Cedars-Sinai Medical Center, known for its commitment to clinical excellence and world-class research, first identified the technology while still in its infancy. Recognizing the need for an improved approach to tinnitus care, Cedars sponsored the development of the innovation and brought together a multi-disciplined team of industry leaders to carry it forward.
"Receiving 510(k) clearance from the FDA is a major milestone and an achievement that represents the dedication of an entire team," says Michael Baker, Otoharmonics CEO. "With the ability to personalize therapy based on the individual needs of each person, we're now raising the bar in tinnitus management."
With their unique sound print identified and mapped, patients listen nightly to a customized therapy using the Levo System while sleeping. The ability to track progress over time and personalize therapy is embedded into the system.
To learn more about the Levo System visit www.otoharmonics.com
Otoharmonics Corporation is a privately held company with headquarters in Portland, Oregon USA. An international team of world–class neuroscientists, clinicians, business professionals and patients, Otoharmonics has developed the Levo System for the management of tinnitus symptoms. With a personal approach and a deep understanding of the impact tinnitus can have, Levo is designed to be user-friendly and capable of delivering custom sound therapy based on the specific needs of each individual.
Apple, iPod touch and iPad are registered trademarks of Apple Inc.
SOURCE Otoharmonics Corporation