Neuromod Devices

Lenire®, the company's lead product, has demonstrated safety and efficacy in three large-scale clinical trials involving over 600 patients. Clinical results show significant reduction in tinnitus severity compared to sound-only stimulation. The device received FDA De Novo approval and CE-mark certification based on these results[1][3][5][8].

In the pivotal TENT-A3 trial, Lenire was clinically superior to sound-only treatment; over 70% of patients with moderate or worse tinnitus who did not improve with sound-only reported clinically significant improvement after six weeks of Lenire treatment. Nearly 89% of participants would recommend Lenire for treating tinnitus[8].

Real-world evidence supports consistent outcomes with clinical trials.

The company continues to expand access through partnerships with hearing healthcare providers and US Department of Veterans Affairs[8].