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From the Medical Valley Center Forchheim - Innovation from Neuromod Devices receives FDA approval

The Medical Valley Center Forchheim is not only symbolic of Forchheim as a strong business location, but is also an essential hub in the Medical Valley network and home to numerous innovative companies - among others in the healthcare sector. These include Neuromod Deutschland GmbH, a spin-off of the Irish company Neuromod Devices. A novel treatment method for tinnitus sufferers was approved in the USA in March of this year and certified by the FDA.

There is still no clinically proven cure for tinnitus, but the Lenire treatment device, which aims to reduce the personal perception of tinnitus, ensures that the vast majority of sufferers perceive the tinnitus less strongly. The relief of the ringing in the ears usually helps to sleep better again and significantly increases the quality of life of a tinnitus sufferer. This effectiveness of Lenire has now been proven in three large-scale clinical studies with more than 600 participants.

What is special about this treatment method is the fact that Lenire works via two different areas of the nervous system: "First of all, Lenire stimulates the auditory nerve via special headphones. At the same time, however, areas in the brain that are responsible for feelings are stimulated by stimulating the tip of the tongue. This is called bimodal neuromodulation. Lenire takes advantage of the brain's plasticity - its ability to learn. Put simply, it teaches it to shift the focus from the tinnitus to other auditory pathways in the brain and thus reduce the perception of the tinnitus," says Florian Elsässer, Chief Strategy & Corporate Development Officer, Neuromod Devices.

Approval in the USA

To gain FDA approval, a very rigorous approval process had to be undergone. This included conducting the third large-scale clinical trial, designed with the support of the FDA, and doing so under tight timelines. "The approval was therefore a huge milestone for us. Neuromod is a young medical technology company and the process was already very elaborate. Without our dedicated team of highly qualified medical professionals and bright minds, it would not have been possible to achieve this ambitious goal," says Elsässer.

"With the approval of Lenire by the FDA, the Medical Valley Center Forchheim is also becoming a little bit visible in the USA through Neuromod and the Medical Valley Cluster is thus further expanding its strong position as an innovative high-tech production location in global medical technology production. We want to continue and expand this positive development through our service and networking activities in the Innovation and Start-up Centre," says Viktor Naumann, Managing Director of Medical Valley Forchheim GmbH.

Decades of research and development work

Lenire is the first device for the treatment of tinnitus that addresses two sensory organs and is now approved as a medical device in the USA as well as in the EU and the UK. The approval by the US Food and Drug Administration (FDA) is a further confirmation of decades of research and development work. Approximately 25 million people in the USA suffer from tinnitus and can now be offered this treatment.

Photo by Mr. Florian Elsäßer & Mr. Viktor Naumann.
Mr Florian Elsäßer Mr Viktor Naumann