Otoharmonics receives Class 2 medical device license for Levo system from Health Canada

Oct 16 2014

Otoharmonics® Corporation, announces that it has received a Class 2 medical device license from Health Canada for the Levo® system, a personalized neuroscience-based sound therapy for use in the temporary relief of tinnitus symptoms. 

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.

Often described as 'ringing in the ears', tinnitus is a result of false signaling in the brain due to inner ear cell damage. Most commonly caused by exposure to loud noise and/or hearing loss, it can have a profound impact on a person's quality of life.

According to the Tinnitus Association of Canada, more than 360,000 Canadians have severe tinnitus. About half of these are so debilitated by the condition that it impairs their quality of life. The American Tinnitus Association says some 50 million people in the United States experience tinnitus, with 2-3 million finding the condition debilitating, causing serious problems such as sleep loss, emotional distress and anxiety.

"Since announcing FDA 510(k) clearance last month, we've received many inquiries from Canadian patients and healthcare providers," says Michael Baker, Otoharmonics CEO. "We're very pleased to announce that the Levo tinnitus system is now available in Canada."

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.