Neuromod USA Inc. has secured a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, enabling the Lenire tinnitus device to be offered as a treatment option for the 2.9 million US Veterans with tinnitus through the Department of Veterans Affairs (VA).

This General Services Administration (GSA) FSS Contract also allows Lenire to be available to patients under the care of the Department of Defense (DoD), Bureau of Prisons, Indian Health Services, and Public Health Services.

Lenire is the first bimodal neuromodulation device to obtain an FSS Contract. It can be prescribed by trained healthcare professionals for tinnitus treatment.

The GSA awarded this contract based on Neuromod Devices' success in clinical trials, commercial sales practices, financial performance, and clinical capabilities.

Tinnitus, often referred to as "ringing in the ears," is a complex neurological condition affecting approximately ten percent of adults.

It involves the perception of sound without an external source and can significantly impact quality of life if untreated.

Tinnitus has been the top service-connected disability compensated by the VA since 1955. In 2023, over 2.9 million veterans received more than $5 billion in compensation for tinnitus. Sixty-three percent of all auditory compensation claims by veterans were for tinnitus.

Tinnitus is the number one service-connected disability.

"The number of veterans with tinnitus is growing at a double-digit rate annually. Neuromod's FSS Contract ensures that current and future veterans have access to clinically proven tinnitus treatment technology.

Everyone at Neuromod is privileged to be serving our veterans by doing our part for tinnitus care."

Lenire's bimodal neuromodulation therapy combines specially designed tones heard through wireless headphones with mild electrical pulses delivered to the tongue via a component called the Tonguetip®.

In March 2023, Lenire became the first tinnitus treatment device to receive FDA Approval through the De Novo pathway. This approval was granted based on the success of the TENT-A3 clinical trial, which demonstrated Lenire's clinical superiority over sound-only stimulation.

70.5% of patients with moderate or severe tinnitus who did not show significant improvement after six weeks of sound-only treatment reported significant improvement following six weeks of treatment with Lenire.

Most patients who benefited from the initial six weeks of sound-only treatment experienced further improvement after an additional six weeks with Lenire.

Nearly 89% of clinical trial participants would recommend Lenire for treating tinnitus.

 

 

 

 

Source: prnewswire.com

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