Levo system 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.

Otoharmonics CEO Michael Baker said that receiving (k) clearance from the FDA is a major milestone and an achievement that represents the dedication of an entire team.

"With the ability to personalize therapy based on the individual needs of each person, we’re now raising the bar in tinnitus management," Baker added.

As per the American Tinnitus Association, around 50 million people in the US experience tinnitus, which is often described as ‘ringing in the ears’.