ACUFREE delivers electromagnetic waves weaker than those found in electronic toys for children.
Its safety and security has been confirmed “in the field” by over 98 clinical tests carried out in the last 4 years, on 2 different European regulatory regimes (MDD 93/42 and MDR-745) and in our 2024 preliminary sales. All without a single case of “adverse effect”.
Clinical and reputational standing of Acufree
Safety
High standing of verified results
Europe-wide certification
Since its creation, Tinnitech has invested in the new European regulation procedures for medical devices MDR-745. EU free trade concession obtained in 2021 (Class 1 of the Ministry of Health), followed by certified clinical protocol and procedure for adaptation to further EU Classification 2a.
Process of verification and validation
All our scientific, medical and production processes are subject to official validation, independent ethics committees and procedures led by clinical partners. The high quality levels of clinical trials are guaranteed and certified by our CRO (LNAge) and our Medical Partners. Currently, clinical testing is carried out in collaboration with the Tor Vergata Foundation: the General Hospital for Trials, the University for Research.
High-ranking international publication
Our clinical tests have been published by JPM (Journal of Personalized Medicine), a top peer-to- peer publication with high impact factor (3.0) and citation score (4.1). IN addition, ACUFREE has been accepted into the trend-setter of the futre by being included in the forthcoming NOV 2024 Special Issue of JPM’s and MDPI’s HEARING DISODERS.
A recognition of the relevance of treating Tinnitus, a symptom affecting 7-out-of-10 people with hearing loss, in a disruptive way and with such significant improvement results.
Highest international testing standards
The clinical trials were carried out in compliance with the highest international standards, subjecting the evaluation criteria to the 5 most well-known and respected international tests in the field: THI, TFI, VAS, SF-36 (quality of life) and Hearing Sensitivity. All 5 tests found improvement trends in the subjects treated, in total absence of adverse effects.
