Neuromod USA Inc. has been awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making the Lenire tinnitus device a treatment option for the 2.9 million U.S. Veterans living with tinnitus through the Department of Veterans Affairs (VA).
The General Services Administration FSS Contract will also make Lenire an option for patients receiving care from the Department of Defense (DoD), Bureau of Prisons, Indian Health Services, and Public Health Services. General Services Administration's decision to award the FSS contract was based on Neuromod Devices' clinical trial success, commercial sales practices, financial performance, and additional clinical capability factors.
Tinnitus, which is commonly known as "ringing in the ears," is a complex neurological condition afflicting an estimated ten percent of all adults. It causes a perception of sound when there is no external source. If left untreated, tinnitus severity can have a significant impact on a person's quality of life.
In March 2023, Lenire became the first tinnitus treatment device to be awarded FDA Approval through the De Novo framework. FDA Approval was granted based on the success of Lenire's controlled large-scale clinical trial, TENT-A3.
That trial confirmed Lenire was clinically superior to sound-only stimulation. 70.5% patients with moderate or worse tinnitus who did not report clinically significant improvement in their tinnitus from six weeks of sound-only, reported clinically significant tinnitus improvement following six weeks of treatment with Lenire. The majority of patients with moderate or worse tinnitus who benefitted from six weeks of sound-only stimulation experienced additional benefit from a further six weeks of treatment with Lenire.
Lenire is a non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus
