Sanuthera Receives 510(k) Clearance for Tinnitus Treatment Device

"The FDA clearance comes as Sanuthera concludes a clinical study at the Cleveland Clinic. In the study, more than 85% of tinnitus sufferers using the Serenity device have shown improvement at 1, 3, and 6 months. To indicate results, the study uses the Tinnitus Handicap Inventory (THI), a self-report tinnitus handicap measure that quantifies the impact of tinnitus on daily living. In the Cleveland Clinic study, the THI has shown a 36% improvement at 6 months, with a 62-point maximum improvement." - See more at: http://www.hearingreview.com/2015/0...nnitus-treatment-device/#sthash.zqY1evmm.dpuf

No idea what this means for real-world, but just thought I'd post this.

 

According to Google: Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

Seems like they plan to commercialize this product but it seems like a hearing aid add-on mixed with sound therapy. Interested to see more about this and how it helps with tinnitus.

 

I'm not 100% on what they are trying to do after reading their website but it seems to be TRT. It sounds like a hearing aid with a noise generator but they aren't very clear about it.

If I had to guess on what makes it unique maybe they run a program to find the best masking sound for the patient before fitting? That really is a guess though.

To quote: "It has been too long that tinnitus sufferers have had to listen to noise or use two completely separate devices for treatment" - reference to hearing aids.

I'm not a fan of these types of units for treatment personally because the frequency response of in-ear devices is poor. They do work for a lot of people but I'm not convinced that it's healthy to pump sound into a damaged auditory cortex that doesn't contain the full audio information you would expect to hear - definitely not for musicians or audiophiles anyway.

 

for me they just want to raise money to fund the lab to do more researche.

 

Here goes that 85% sucess rate figure again.