Sanuthera Receives 510(k) Clearance for Tinnitus Treatment Device

Discussion in 'Research News' started by Greg Moreau, Aug 17, 2015.

    1. Greg Moreau

      Greg Moreau Member Benefactor

      Tinnitus Since:
      Cause of Tinnitus:
      Rock Music and who knows what else...
      "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:

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

      JabbingJab Member Benefactor

      Tinnitus Since:
      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.
    3. Steve H

      Steve H Director Staff Benefactor Hall of Fame Advocate

      Sheffield, UK
      Tinnitus Since:
      Cause of Tinnitus:
      Flu, Noise-induced, Jaw trauma
      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.
      • Agree Agree x 1
    4. preslys

      preslys Member

      Tinnitus Since:
      Cause of Tinnitus:
      for me they just want to raise money to fund the lab to do more researche.
    5. Nucleo

      Nucleo Member Benefactor

      Tinnitus Since:
      Here goes that 85% sucess rate figure again.

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