FDA approval process changed

16.12.2020

Roggwil, December 16, 2020 – For the US Food and Drug Administration (FDA) authorization process, the 510 (k) authorization process (Premarket Notification Submissions) has been changed to the Article 513 (g) authorization process. This step became necessary because in the process according to 510 (k) no remotely comparable products were identified on the American market. In the 513 (g) procedure, the FDA itself classifies products. This simplifies the approval process for us and enables a faster market launch of the tinniwell in the US.

++ About Resaphene Suisse AG

Resaphene Suisse AG, based in Roggwil, Switzerland, is a medical technology company that was founded in 2015 and has been selling a tinnitus therapy device under the name tinniwell since 2016. Resaphene Deutschland GmbH in Constance, Resaphene UK Ltd. act as further sales companies in London and Resaphene US LLC in the US.

++ Contact for questions:

Resaphene Suisse AG
Mrs. Anke Rauterkus (Chief Executive Officer)
Bahnhofplatz 5
9322 Egnach
Switzerland
T. +41 714500668
a.rauterkus@resaphene.ch

Back

Testimonials

Tinniwell fits very well into my everyday life. It can be used almost anywhere and is also a good companion when traveling due to its handy size. My tinnitus has completely disappeared from my left ear. My quality of life has improved significantly. I’m rarely irritable and much more relaxed.

Lisa Neumeier

I am a trainee and have been suffering from ear noises for about a year. However, since I am only 18 years old, I could not and did not want to accept that this tone will remain for the rest of my life. Then I learned about tinniwell from a friend and tried it out directly.

After the first week of therapy, I was able to sleep again, relax and work fully again at my training place. 6 weeks after the first application, I can deal with my tinnitus very well, because it is about 40% quieter than before the therapy.

Anna Bergmann

Karlsruhe

After four days I no longer had a whistle in my right ear, the left ear then continued for another two weeks until there was an improvement.

I am so happy now that tinniwell has given me a better quality of life. I sleep through again, can now devote myself more to my family and I have more energy for my independence.

Jonny Denaro

München

I can recommend this holistic effective world first, to every tinnitus sufferer. Thank you again for the excellent and friendly service.

Werner Eisele

Sonja Dinnebier

"With tinniwell my tinnitus has almost completely disappeared. The combination of music and warmth is great, because it not only drowns out the noise, but the warmth in particular ensures relaxation and balance. "

Karin Baldauf

"The tinniwell is a great invention for people who suffer from tinnitus. For me more quality of life again. "

Werner Eisele

"I can recommend this holistic effective world first, to every tinnitus sufferer. Thank you again for the excellent and friendly service. "