At the beginning of the month, Oregon-based Otoharmonics received FDA clearance to market its Levo system. This unique software application uses personalized, neuroscience-based sound therapy to help patients cancel out the effects of tinnitus. With custom-fit earbuds and proprietary software for the Apple iPad and iPod Touch, the system is designed to be simple to use for both physicians and patients.
Built for Patient Welfare
Otoharmonics stressed that its design was intended from the beginning to address the needs of patients to have an easy-to-use and clinically effective tinnitus treatment. They sought to build off the masking technology that was already in use, and adapt it for use with the Apple devices.
The program works by identifying a patient’s unique sound print, the sounds that are most effective at eliminating their tinnitus. People then use the device at night while sleeping. They can then track the effectiveness of their program and tweak their soundprint to improve it even further.
Does It Work?
Yes, it’s nice that this device is convenient and easy to use, but if it doesn’t work, it’s not a good treatment option. Unfortunately, this is a hard question to answer. Levo was processed through the FDA’s 510(k) process, which doesn’t always demand studies to prove effectiveness. The application to the FDA mentions “nonclinical testing” but doesn’t give any information.
However, the device was cleared as being substantially equivalent to the SoundCure device, so looking at clinical data for that device may give us a sense of what we might expect. Fortunately, SoundCure has assembled a lot of clinical data. In the most recent study, it was found that about a third of patients didn’t respond to any type of noise masking. Of those that did respond to noise masking, the SoundCure device seemed to perform very well compared to other maskers.
Try Curing Tinnitus before Masking It
Although many people will have to rely on masking to attempt to cope with tinnitus, it’s often a good idea to try procedures that have the chance of eliminating tinnitus before settling for an attempt to mask it. TMJ treatment has been proven effective for the majority of tinnitus sufferers in at least reducing tinnitus, which makes it a better option all around than masking.