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updated 10:10 PM PDT, May 3, 2016

Portland biotech company receives key FDA clearance

Otoharmonics received 510(k) clearance for from the Food and Drug Administration for Levo, a product that treats tinnitus.

Otoharmonics received 510(k) clearance for from the Food and Drug Administration for Levo, a product that treats tinnitus.

Tinnitus is best described as a "ringing in the ears" that results from false signaling in the brain due to inner ear cell damage. It's most commonly caused by exposure to loud noises. An estimated 50 million Americans suffer from the condition, according to the American Tinnitus Association.

“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, CEO of Otoharmonics, in a release. “With the ability to personalize therapy based on the individual needs of each person, we’re now raising the bar in tinnitus management.“

Read more at Portland Business Journal

Last modified onMonday, 19 October 2015 11:42

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