Neuromod Devices Ltd. is proud to announce that the US Food and Drug Administration (FDA) has granted De Novo approval to Lenire.
The FDA granted approval following the success of Lenire’s third large scale clinical trial, TENT-A3. TENT-A3 demonstrated that 79.4% of all trial participants experienced a clinically significant improvement in tinnitus severity. Notably, 70.5% of those with moderate and above tinnitus had a significant improvement after six weeks using Lenire having had no response to six weeks of audio-only therapy. As a result, 88.6% of TENT-A3 patients recommended Lenire.
“Lenire’s approval further validates over a decade of R&D that resulted in a safe solution that provides tinnitus relief,” said Neuromod CEO, Dr. Ross O’Neill.
Lenire will be available to the 25 million Americans suffering with tinnitus, 2.7 million of whom are veterans, from April 2023.
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