Cedars-Sinai-backed app for Apple iPad, iPod touch receives U.S. FDA approval

“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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8 Comments

    1. Drinks lots of water, take Vitamin B Complex daily and refrain from extended use of painkillers like Hydrocodone (Vicodin, Lortab). Rush Limbaugh went deaf from oxycodone.

    2. Also avoid any and all nose sprays and sprays in the face area all together and of course avoid all loud noise areas. I had the same problem for over a year and carefully controlling my diet, good supplements and it is gone for now at least.

      Good luck.

  1. Can Doctors prescriptions for iPhones and apps be far behind?

    Heaalth Insurance reimbursement for my iPhone and some apps and peripheral devices, now I like that business model! Go Apple!

  2. Yep, 22 years in the military and I’ve had tinnitus now for well over 20 years since I left. Too many loud noises. A love of live music doesn’t help either. Just remember that every time ANY noise exposure leaves your ears ringing, you have done some damage to your hearing. The damage is cumulative over time and currently unrepairable. Mostly I can mentally dial the constant ringing out of my consciousness, but any time I want to listen to music I become aware of it and it sucks. And please, lots of water, taking vitamins and other quackery will do nothing for it. It is currently unrepairable by any treatment, so it will be interesting to see how this attempt goes. I know I’ll be first on the bandwagon to try it when it becomes available.

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