Otoharmonics’ Levo System Receives Class 2 Medical Device License in Canada

Health Canada has granted a Class 2 medical device license to Otoharmonics’ Levo System for use in temporarily relieving symptoms of tinnitus, or “ringing in the ears.”

The news follows FDA clearance of the Portland, Ore., company’s sole product last month. According to Otoharmonics CEO Michael Baker, the company soon began receiving inquiries from Canadian patients and healthcare providers asking about Levo’s availability there.

The Levo System uses a patient’s natural cognitive abilities to identify and map unique tinnitus sounds. Patients receive the customized aural therapy while sleeping and can share their results with their doctor to determine if improvements are needed over time.

Tinnitus can occur when cells in the inner ear are damaged, often from exposure to loud noise, resulting in false signaling in the brain. More than 360,000 Canadians have severe tinnitus, with half being so affected by the condition that it impairs their quality of life, according to the Tinnitus Association of Canada.  — Kellen Owings

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