Neuromod's FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus USA - English USA - English USA - Français
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~ Neuromod USA Inc. has recently been awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making their Lenire tinnitus device available as a treatment option for the 2.9 million US veterans living with tinnitus through the Department of Veterans Affairs (VA). This marks a significant milestone for Neuromod as Lenire is the first and only bimodal neuromodulation device to receive such recognition.

The General Services Administration FSS Contract will also make Lenire an option for patients receiving care from other government agencies such as the Department of Defense (DoD), Bureau of Prisons, Indian Health Services, and Public Health Services. This means that more patients suffering from tinnitus will now have access to this innovative treatment option.

Tinnitus, commonly known as "ringing in the ears," is a complex neurological condition that affects an estimated ten percent of all adults. It causes a perception of sound when there is no external source, and if left untreated, it can significantly impact a person's quality of life. In fact, tinnitus has been the number one service-connected disability compensated for by the VA since 1955, with over 2.9 million veterans receiving more than $5 billion in compensation in 2023 alone.

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Eric Timm, CEO of Neuromod USA and President of Global Commercial Operations at Neuromod Devices, stated that "tinnitus is the number one service-connected disability" and that "the number of veterans with tinnitus is growing at a double-digit rate annually." He also emphasized how Neuromod's FSS Contract ensures that current and future veterans have access to clinically proven tinnitus treatment technology.

Lenire's bimodal neuromodulation works by pairing specially designed tones heard through wireless headphones with mild electrical pulses that stimulate the tongue through a component called the Tonguetip®. This unique approach has shown promising results in clinical trials, leading to Lenire becoming the first tinnitus treatment device to be awarded FDA Approval through the De Novo framework in March 2023.

The FDA Approval was granted based on the success of Lenire's controlled large-scale clinical trial, TENT-A3, which confirmed its superiority over sound-only stimulation. In fact, 70.5% of patients with moderate or worse tinnitus who did not report clinically significant improvement from six weeks of sound-only stimulation reported significant improvement after six weeks of treatment with Lenire. Additionally, the majority of patients who benefitted from sound-only stimulation also experienced further improvement with an additional six weeks of treatment with Lenire.

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Furthermore, nearly 89 percent of clinical trial participants would recommend Lenire as a treatment option for tinnitus. This is a testament to the effectiveness and potential impact that this device can have on those suffering from this debilitating condition.

With the FSS Contract now in place, Neuromod is committed to providing access to this groundbreaking technology for veterans and other patients in need. As Timm stated, "Everyone at Neuromod is privileged to be serving our veterans by doing our part for tinnitus care."
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