Roggwil, December 16, 2020 – For the approval procedure in the USA with the US Food and Drug Administration (FDA), the process has been switched from the 510(k) Approval Process (Premarket Notification Submissions) to the approval process according to Article 513(g). This step was necessary because no remotely comparable products have been identified in the American market in the 510(k) procedure. In the 513(g) procedure, the FDA classifies products itself. This simplifies the approval process for us and allows for a faster market launch of tinniwell in the USA.

++ About Resaphene Suisse AG

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

++ Contact for inquiries:

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