Health Canada grants Class 2 medical device licence for Otoharmonics’ Levo tinnitus system

16 October 2014 (Last Updated October 16th, 2014 18:30)

Health Canada has granted a Class 2 medical device licence to US-based Otoharmonics' Levo system, a personalised neuroscience-based sound therapy developed for use in the temporary relief of tinnitus symptoms.

Levo

Health Canada has granted a Class 2 medical device licence to US-based Otoharmonics' Levo system, a personalised neuroscience-based sound therapy developed for use in the temporary relief of tinnitus symptoms.

Levo leverages the brain's natural cognitive abilities to identify and map an individual's sound print, with the help of custom-fit ear buds and software on Apple's iPad and iPod touch mobile digital devices.

Tinnitus is often described as 'ringing in the ears', which is the result of false signalling in the brain due to inner ear cell damage. It is most commonly caused by exposure to loud noise or hearing loss.

More than 360,000 people in Canada have severe tinnitus and about half of these are so debilitated by the condition that it impairs their quality of life, according to the Tinnitus Association of Canada.

According to the American Tinnitus Association, more than 50 million people in the US experience tinnitus, with two to three million finding the condition debilitating, causing serious problems such as sleep loss, emotional distress and anxiety.

"The Levo system also has the ability to track progress over time and personalise therapy."

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."

The company said that with their sound print identified and mapped, patients can listen nightly to a customised therapy using the Levo system while sleeping.

The Levo system can also track progress over time and personalise therapy. In September, the company had secured 510(k) clearance from US Food and Drug Administartion (FDA) for the Levo system.


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