European rules on medical devices change radically: all pre-2021 clinical trials are no longer considered, so they must be repeated according to the new criteria of the MDR-745 directive. The promising preliminary 2020 clinical results are set aside; everything is started again from scratch. Tinnitech initiates Phase Two. The Technology evolves: the control panel disappears, the devices become intelligent, operating with autonomous units; a 3rd active element is integrated, more applications and healing functions are integrated. The 2nd Patent is filed in March 2021. The foundations are laid for the “synchronous multimodal therapy” : 3 elements acting simultaneously, in anti-tinnitus function.
