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Medical Devices / Submissions and Approvals

Otoharmonics Gets FDA Green Light for Tinnitus Device

Sept. 5, 2014
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Portland, Ore., devicemaker Otoharmonics said Wednesday that the FDA has granted 510(k) clearance to its only product, the Levo System, for use in temporarily relieving symptoms of tinnitus, or “ringing in the ears.”

The personalized Levo System is based on neuroscience-based sound technology, which utilizes a patient’s natural cognitive abilities to identify and map unique tinnitus sounds. Patients then receive customized aural therapy while sleeping, Otoharmonics says.

User-friendly software lets patients listen to their personalized sound match on an Apple iPod, while custom-fit ear buds allow for optimal positioning and controlled delivery of sound therapy, the company adds. Patients share their individual progress with a hearing professional to determine if improvements are needed over time.

Tinnitus is triggered by inner ear cell damage, often from exposure to loud noise, resulting in false signaling in the brain. About 50 million Americans experience the disorder to some degree, according to the American Tinnitus Association. — Kellen Owings

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