Otoharmonics Receives FDA 510(k) Clearance for the Levo® System

       Otoharmonics Receives FDA 510(k) Clearance for the Levo® System

PR Newswire

PORTLAND, Ore., Sept. 3, 2014

PORTLAND, Ore., Sept. 3, 2014 /PRNewswire/ -- For use in temporarily relieving
the symptoms of tinnitus, the Levo System is a personalized,
neuroscience-based sound therapy. 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.

Patients identify their unique tinnitus sound print using the Levo System

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 American Tinnitus Association, an estimated 50 million people
in the United States experience tinnitus to some degree. While it's only a
minor annoyance for some, for 2-3 million it's completely debilitating,
causing serious problems such as sleep loss, emotional distress and anxiety.

From the start, the Levo System was developed with the wellbeing of patients
in mind. The team at Cedars-Sinai Medical Center, known for its commitment to
clinical excellence and world-class research, first identified the technology
while still in its infancy. Recognizing the need for an improved approach to
tinnitus care, Cedars sponsored the development of the innovation and brought
together a multi-disciplined team of industry leaders to carry it forward.

"Receiving 510(k) clearance from the FDA is a major milestone and an
achievement that represents the dedication of an entire team," says Michael
Baker, Otoharmonics CEO. "With the ability to personalize therapy based on the
individual needs of each person, we're now raising the bar in tinnitus
management."

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.

To learn more about the Levo System visit www.otoharmonics.com

Otoharmonics Corporation is a privately held company with headquarters in
Portland, Oregon USA. An international team of world–class neuroscientists,
clinicians, business professionals and patients, Otoharmonics has developed
the Levo System for the management of tinnitus symptoms. With a personal
approach and a deep understanding of the impact tinnitus can have, Levo is
designed to be user-friendly and capable of delivering custom sound therapy
based on the specific needs of each individual.

Apple, iPod touch and iPad are registered trademarks of Apple Inc.

Media Inquiries: Brenda Edin Email 503.310.4417
Consumer Inquiries: info@otoharmonics.com

Patients listen to sound therapy nightly using the Levo System



Photo - http://photos.prnewswire.com/prnh/20140903/142622
Photo - http://photos.prnewswire.com/prnh/20140903/142623

SOURCE Otoharmonics Corporation

Website: http://www.otoharmonics.com
 
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