CHICAGO, ILLINOIS — 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 2.9 million US Veterans living with tinnitus through the Department of Veterans Affairs (VA).
This contract will also extend the availability of Lenire to patients receiving care from the Department of Defense (DoD), Bureau of Prisons, Indian Health Services, and Public Health Services. Lenire is the first bimodal neuromodulation device to receive such a contract, allowing it to be prescribed by trained healthcare clinicians for tinnitus treatment.
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 capability factors.
Tinnitus, commonly known as “ringing in the ears,” is a complex neurological condition affecting an estimated ten percent of adults. It causes a perception of sound without an external source and can significantly impact quality of life if untreated. Since 1955, tinnitus has been the top service-connected disability compensated by the VA. In 2023, over 2.9 million veterans received more than $5 billion in compensation, with tinnitus accounting for 63 percent of all auditory compensation claims.
“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.”
–Eric Timm, Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations
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
About Neuromod Devices
Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland and the United States. Neuromod specializes in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations with chronic and debilitating conditions. The lead application of Neuromod’s technology is in the field of tinnitus, where extensive clinical trials have confirmed the efficacy of its non-invasive neuromodulation platform.
For more information, visit www.neuromoddevices.com.
About Lenire®
Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials. It has CE-mark certification for the treatment of tinnitus under the supervision of a qualified healthcare professional in Europe and has received a De Novo Approval Grant by the US FDA. Further details about Lenire®, including a list of providers, can be found at www.lenire.com.
References & Notes
- Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
- Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, 2022
- Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (2023)
- NIDCD
- US VA Benefits Report Fiscal Year 2023
- TENT-A3 trial data
