Neuromod USA has inked a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making its tinnitus treatment device, Lenire, an option for veterans through the Department of Veterans Affairs (VA).
The device, which won de novo approval from the US Food and Drug Administration (FDA) in March 2023, combines acoustic and electrical intraoral stimulation. The device consists of three main components: Bluetooth headphones delivering customised sound stimuli to the auditory nerve; a lightweight handheld controller for adjusting treatment length and intensity; and Toungetip, an intra-oral device that provides gentle electrical stimulation to the tongue to activate nerves.
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The General Services Administration Federal Supply Schedule 65 II Medical Equipment and Supply Contract will also make Lenire an option for patients receiving care through the Department of Defense, the Bureau of Prisons, Indian Health Services and Public Health Services.
Neuromod secured FDA de novo approval following the TENT-A3 clinical trial, which involved 112 enrolled patients and was supported by confirmatory real-world evidence from 204 patients. In the trial, 79.4% of the patients reported a clinically significant improvement, 88.6% would recommend Lenire as a tinnitus treatment and 82.4% were compliant with the bimodal treatment.
Tinnitus is the perception of ringing or other noises in the ears and is often found in military veterans due to frequent exposure to loud noises such as gunfire, explosions and machinery during service. According to Neuromod, there are 2.9 million US veterans living with the condition.
The company received €30m ($33m) in funding in 2023 to support further commercialisation of Lenire in the US. The financing included €15m in an expansion of Series B led by Panakès Partners, while participants also included existing investor Fountain Healthcare Partners. The European Investment Bank provided the remaining €15m in venture debt.
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By GlobalDataEric Timm, Neuromod USA’s CEO, said: “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.”
As well as tinnitus, neuromodulation devices are being developed to treat a variety of neurological disorders including epilepsy, severe migraine, insomnia and depression. In March 2024, Finland-based Sooma Medical raised €5m in venture funding to expand market access for its transcranial direct current stimulation device for at-home treatment of depression.
The global market for neuromodulation devices was worth approximately $6.6bn in 2022 and is expected to reach more than $8.9bn in 2027, as per GlobalData market analysis.
