FDA approval process for tinnitus therapy tinniwell continues

13.07.2022

Roggwil, July 13, 2022 – Due to the COVID pandemic, work for the FDA approval of the tinniwell was stopped at the beginning of 2021. This has now been resumed and Chief Medical Officer Thomas Rauterkus has been commissioned to manage the project. The aim is to complete this project within 12 months and thus gain entry into the medical technology market in the USA.

We currently assess the market environment as very favorable, since the only serious competitor, Neuralink, led by the investor Elon Musk, suffered a serious setback in the FDA approval of its solution. In animal experiments, brain implants were implanted in monkeys, which, among other things, were later to cure tinnitus. Many of these experimental animals have died for a variety of reasons. Elon Musk estimates that the application will still be available in 5 years.

The management of Resaphene Suisse AG sees the time estimate and the widespread use of the therapy as unrealistic. Even if Neuralink’s product were approved, we estimate the cost of the therapy to be in the five to six-digit dollar range. A reimbursement by health insurance companies is excluded, as this would completely overwhelm the budget of the insurance companies due to the large number of tinnitus patients. A private assumption of costs by the patients themselves will probably only occur in isolated cases, since most of them simply do not have the financial means.

This means that tinniwell remains the only available tinnitus therapy that has been proven to cure tinnitus. Due to the unavailability of competing products with similar performance characteristics, Resaphene Suisse AG currently holds a monopoly position in tinnitus therapy.

++ Contact for questions:

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

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Testimonials

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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. "