The Levo system uses sound therapy to trick the brain.
The FDA has given clearance to startup Otoharmonics for its iPad and iPod Touch application that uses sound therapy to teach the brain to ignore persistent ringing caused by tinnitus.
The 510k clearance for what the company, which was formed by the Baker Group and supported by Cedars-Sinai Medical Center, calls the Levo system covers the software, earbuds and the Apple-built devices themselves, MobiHealthNews reported. In the future, Otoharmonics will need additional FDA clearances if there are new versions of the system for Android or other systems, or new Apple products like the much-anticipated iWatch.
Wearing custom-fitted earbuds, patients use the Levo application to “map” the sounds they hear. In turn, the application produces a therapy based on those sounds that patients listen to at night during unconscious brain function. Tinnitus, which the American Tinnitus Association says affects about 50 million people in the U.S. alone, is caused by false signaling in the brain that produces persistent ringing.
“We work on this principle of habituation,” Brenda Edin, the head of Otoharmonics marketing, told MobiHealthNews. “It’s like living by a train station or an airport. When you first move in, all you hear are planes landing or trains going by. After months you don’t hear them at all. And the reason you don’t hear them at all is because your brain gets used to those sounds and realizes and understands that they’re not a priority and drops them down on the radar.”
San Diego-based biotech company Otonomy ($OTIC) is in line for a Phase I study next year of a preclinical tinnitus treatment dubbed OTO-311. Swiss drugmaker Auris Medical ($EARS) is also working on a treatment for acute inner ear tinnitus. The drug, called Am-101, is an injectable gel administered in a single treatment cycle to shut down cochlear NMDA receptors and relieve the ringing of the ears associated with tinnitus.