VICTORIA B.C., Sept. 11, 2014 – StarFish Medical announces its client, Otoharmonics® Corporation, has received FDA 510(k) clearance for the Levo® System, a sound therapy for use in temporarily relieving the symptoms of tinnitus. Another August milestone for Otoharmonics was adding CAN/CSA registration to their existing ISO 13485 certification. The Levo System is already approved for marketing in Europe (CE Mark).
“We were pleased to find an efficient and effective path to FDA 510(k) clearance for this Class II iOS device,” noted Scott Phillips, President and Founder of StarFish Medical. “It’s rewarding to know that an advanced tinnitus management solution is now available to patients.”
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.
“Receiving 510(k) clearance from the FDA is a an achievement that represents the effort and dedication of an entire team,” says Michael Baker, Otoharmonics CEO. “The technical engineering, quality management and documentation expertise at StarFish Medical was particularly critical in this process.”
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.
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
About StarFish Medical
StarFish Medical is a Medical Device Design company with a full complement of design, development, and manufacturing services. We use our Pathfinder™ process to reduce wasted effort and increase success for medical device product definition, technical engineering, and product development. Prototype and volume production are delivered within an ISO 13485 certified Quality Management System with an FDA registered manufacturing and clean room facility.
About Otoharmonics Corporation
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.
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