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Otoharmonics receives Health Canada approval for Levo system

US-based Otoharmonics has secured a Class 2 medical device license from the Health Canada for its Levo system, which is a personalized neuroscience-based sound therapy developed for use in the temporary relief of tinnitus symptoms.

Levo

Using custom-fit ear buds and software on Apple iPad and iPod touch mobile digital devices, Levo identifies and maps an individual’s unique sound print, and leverages brain’s natural cognitive abilities.

Otoharmonics CEO Michael Baker said: "Since announcing FDA 510(k) clearance last month, we’ve received many inquiries from Canadian patients and healthcare providers.

"We’re very pleased to announce that the Levo tinnitus system is now available in Canada."

Tinnitus, which often described as ringing in the ears, is a result of false signaling in the brain due to inner ear cell damage. It results due to exposure to loud noise or hearing loss.


Image: Patients identify their unique tinnitus sound print using the Levo System.Photo: courtesy of PRNewsFoto/Otoharmonics Corporation.