Neuromod’s FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus

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 US Veterans living with tinnitus⁵ 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.

The Lenire Device is the first bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) Contract. It can be prescribed when appropriate by a trained healthcare clinician for the treatment of tinnitus.

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.⁴ 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.

Tinnitus has been the number one service-connected disability compensated for by the VA since 1955. More than 2.9 million veterans received more than $5 billion in compensation in 2023.⁵ Sixty-three percent of all auditory Veteran Compensation Claims were for tinnitus.⁵

“Tinnitus is the number one service-connected disability,” said Eric Timm, Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations.

“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 works by pairing specially designed tones heard through wireless headphones with mild electrical pulses that stimulate the tongue through a component called the Tonguetip^®.

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.³ 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.^{3, 6}

Nearly 89 percent of clinical trial participants would recommend Lenire to treat tinnitus.⁶

References 

1. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
2. 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)
3. Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (2023)
4. https://www.nidcd.nih.gov/health/tinnitus
5. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/
6. TENT-A3 trial data in preparation for publication: https://clinicaltrials.gov/study/NCT05227365?intr=lenire&rank=1