“Otoharmonics, a startup out of the Baker Group supported by Cedars-Sinai Medical Center, has received FDA 510(k) clearance for an iPad or iPod Touch application that treats a medical condition called tinnitus,” Jonah Comstock reports for mobihealthnews. “Technology behind the Levo system, originally developed at Cedars-Sinai, uses sound therapy to train the brain to ignore the ringing sounds caused by tinnitus.”
“The FDA clearance is for the whole system: the software, the earbuds, and the Apple devices themselves,” Comstock reports. “This means Otoharmonics will need to get additional clearances if they want to develop future versions for Android or other platforms, or even for subsequent generations of Apple products.”
Comstock reports, “Unlike other tinnitus therapies, they can quantitatively measure improvement through the app. In time, that quantitative outcomes data could be enough to get the system classified as a treatment not just a therapy, thus increasing the chances of regulatory reimbursement.”
Read more in the full article here.
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