Neuromod’s FDA-cleared Lenire device is now a treatment option for 2.9 million U.S. veterans suffering from tinnitus

Lenire, the first and only FDA-approved tinnitus treatment device of its kind, is currently an option for the 2.9 million veterans with tinnitus on Veterans Affairs.⁵
Lenire is the first and only bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) contract from the U.S. government.
The General Services Administration 65 II federal delivery schedule for medical equipment and supply contracts will also make Lenire an option for patients receiving care through the Department of Defense (DoD), Bureau of Prisons, Indian Health Service and Public Health Service.

CHICAGO, June 17, 2024 /PRNewswire/ — Neuromod USA Inc. received Federal Supply Schedule 65 II for medical equipment and supplies from the U.S. government, making the Lenire tinnitus device a treatment option for the 2.9 million U.S. veterans suffering from tinnitus⁵ through the Department of Veterans Affairs (VA).

The FSS General Services Administration contract will also provide Lenire an option for patients receiving care from the Department of Defense (DoD), Bureau of Prisons, Indian Health Service and Public Health Service.

Patient with tinnitus using Lenire tinnitus treatment device

Lenire is the first bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) contract. If necessary, it may be prescribed by a trained doctor to treat tinnitus.

The 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 opportunity factors.

Tinnitus, commonly known as “ringing in the ears”, is a complex neurological condition that affects approximately ten percent of all adults.⁴ It causes the perception of sound when there is no external source. If left untreated, the severity of tinnitus can have a significant impact on a person’s quality of life.

Since 1955, tinnitus has been the most common service-connected disability compensated by the VA. More than 2.9 million veterans have received over $5 billion as compensation in 2023⁵ Sixty-three percent of all veterans compensation claims were for tinnitus.⁵

“Tinnitus is the most common service-connected disability.” he said Eric TimmNeuromod USA CEO and President of Global Commercial Operations for Neuromod Devices.

“The number of veterans suffering from tinnitus is growing at a double-digit rate each year. Neuromod’s FSS contract provides current and future veterans with access to clinically proven tinnitus treatment technology. Everyone at Neuromod is honored to serve our veterans by doing our part to treat tinnitus.”

Lenire bimodal neuromodulation combines specially designed sounds heard through wireless headphones with gentle electrical impulses that stimulate the tongue through an element called the tongue tip^®.

IN March 2023, Lenire became the first tinnitus treatment device to receive FDA approval under the De Novo program. The FDA approval was based on the success of Lenire’s large-scale controlled clinical trial, TENT-A3.

This study confirmed that Lenire is clinically more effective than sound-only stimulation. 70.5% of patients with moderate or more severe tinnitus who reported no clinically significant improvement in their tinnitus after six weeks of sound-only treatment reported clinically significant improvement in their tinnitus after six weeks of treatment with Lenire.³ Most patients with moderate or more severe tinnitus who benefited from six weeks of sound-only stimulation experienced additional benefit after another six weeks of treatment with Lenire.^{3, 6}

Nearly 89 percent of clinical trial participants would recommend Lenire for treating tinnitus.⁶

About Neuromod devices

Founded in 2010, Neuromod Devices is a global medical technology company with offices in IrelandAND United States of America. Neuromod specializes in the design and development of neuromodulation technologies to meet the clinical needs of underserved patient populations suffering from chronic and debilitating diseases.

The leading application of Neuromod’s technology is in tinnitus, where Neuromod has completed extensive clinical trials to confirm the effectiveness of its non-invasive neuromodulation platform in the treatment of this common disorder.

for more information visit www.neuromoddevices.com.

About Lenire®

Lenir^® is the first non-invasive tinnitus treatment device using bimodal neuromodulation that has been shown to alleviate and soothe tinnitus in large-scale clinical trials.^1,2,6

Lenir^® is CE certified for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional Europe and received De Novo approval from the US FDA.

More details about Lenire®, including a list of suppliers, can be found on the website www.lenire.com.

References and notes

Conlon et al., Sci. Translator. Med. 12, eabb2830 (2020)
Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)
Neuromod Devices Ltd., Lenire (CR-201) Physician Manual, (2023)
https://www.nidcd.nih.gov/health/tinnitus
US VA Benefits Report for Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/
Data from the TENT-A3 study being prepared for publication: https://clinicaltrials.gov/study/NCT05227365?intr=lenire&rank=1

Photo – https://mma.prnewswire.com/media/2439154/Lenire_Neuromod_Devices.jpg