Otoharmonics Receives FDA 510(k) Clearance for Levo Tinnitus Sound Therapy System
For use in temporarily relieving the symptoms of tinnitus, the Levo System® is a personalized, neuroscience-based sound therapy recently made available by Otoharmonics Corp, Portland, Ore. According to the company, the Levo System leverages the brain’s natural cognitive abilities, and 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.
From the start, the Levo System was developed with the wellbeing of patients in mind, reports Otoharmonics. A team at Cedars-Sinai Medical Center 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 Otoharmonics CEO Michael Baker. “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.
Otoharmonics is a privately held company and has reportedly developed the Levo System with input from international team of world-class neuroscientists, clinicians, business professionals, and patients. Levo is reportedly designed to be user-friendly and capable of delivering custom sound therapy based on the specific needs of each individual.
To learn more about the Levo System visit: www.otoharmonics.com
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