On Mar. 6, 2023, Neuromod Devices announced that the US Food and Drug Administration (FDA) had granted De Novo approval to Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.

Tinnitus, which is commonly known as ﾑringing in the earsﾒ, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans2 are currently suffering from tinnitus.