Otoharmonics Receives FDA 510(k) Clearance for the Levo System


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.

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.

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.

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