Currently, tinnitus treatment is extremely limited; a product like Lenire will provide much-needed relief for millions of people who deal with the condition. De Novo approval was based on the results of TENT-A3 (NCT05227365), a single-arm, repeated measures, prospective investigation, conducted at 3 independent sites from March to October 2022. A total of 112 participants were enrolled; researchers sought to compare the effects of 6 weeks bimodal neuromodulation with 6 weeks sound therapy alone. Though tinnitus treatment cost is not exorbitant on the individual level—it costs the health care system approximately $660 per patient—these costs add up due to the prevalence of tinnitus. FDA grants Lenire tinnitus treatment device De Novo approval.

Source: CNN March 14, 2023 18:08 UTC