Cedar Sinai-supported tinnitus app for FDA approval
Release date: 2014-09-10
Otoharmonics, backed by Cedar Sinai Medical Center, has been approved by the FDA to use the Levo system app on the iPad and iTouch to treat tinnitus. The technique used on the Levo system, developed by Cedar Sinai, can be used for the sound treatment of tinnitus, training the brain to ignore ringing caused by tinnitus.
Tinnitus is the constant ringing of the ear and is often treated as a hearing disorder. It is actually caused by a false signal from the brain. According to the number of the Tinnitus Association, there are 50 million people affected by the disease in the United States.
Otoharmonics' CMO Brenda Aiding told reporters: "We design apps according to this principle. It's like you live near a train station or airport. When you first move there, you will hear the plane landing and The train passes by. But you can't hear it in a few months. The principle is that your brain is used to these sounds, and the brain realizes and understands that these sounds are not the highest priority, so filter out the sounds."
The FDA license is a system-wide license that includes software, headsets, and the Apple device itself. This means that Otoharmonics needs to obtain additional licenses if it wants to develop an Android version or even Apple releases a new generation of products.
To use the Levo system, the doctor will need to open the system to the patient and customize the headset according to their ears. The doctor then hands over the headset and pre-installed system to the patient at the next visit. The patient uses the app to set the sound they hear, and the app generates a treatment based on the sound. In order to take advantage of the brain's unconscious process, the patient listens to the sound of the app while sleeping.
Aiding said that Otoharmonics was licensed 90 days after submitting the application. However, she also said that there will be some time for Otoharmonics to be trained in the use of hearing specialists. Currently they train hearing specialists in Los Angeles, Portland, Oregon, New York and Chicago.
The company will sell the system to the hospital and then sell it to the patient. Aiding said that because the system is not a treatment, the medical insurance reimbursement is not available for most patients. But for veterans, they are the largest group of patients with tinnitus, and they can reimburse the system for expenses.
Unlike other therapies, the Levo system measures the extent of tinnitus improvement through app quantification. Quantitative outcome data can be obtained from the system, which can define the system as a treatment rather than just a therapy, thus increasing the chances of reimbursement.
Original link: http://mobihealthnews.com/36288/cedars-sinai-developed-tinnitus-app-gets-fda-clearance/
Source: Kexun Medical Network
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