- Lenire, the first and only tinnitus treatment device of its
kind approved by the FDA, is now an option for 2.9 million veterans
living with tinnitus through Veterans Affairs.5
- Lenire is the first and only bimodal neuromodulation device to
be awarded a Federal Supply Schedule (FSS) Contract from the US
Government.
- 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 (DoD), the Bureau of Prisons, Indian Health Services, and
Public Health Services.
CHICAGO,
June 17,
2024 /PRNewswire/ -- 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.
Lenire 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
About Neuromod Devices
Founded in 2010, Neuromod Devices is a global medical technology
company with offices in Ireland,
and the United States of America.
Neuromod specialises in the design and development of
neuromodulation technologies to address the clinical needs of
underserved patient populations who live with chronic and
debilitating conditions.
The lead application of Neuromod's technology is in the field of
tinnitus, where Neuromod has completed extensive clinical trials to
confirm the efficacy of its non-invasive neuromodulation platform
in this common disorder.
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.1,2,6
Lenire® has CE-mark certification for the treatment
of tinnitus under the supervision of an appropriately 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,
https://www.nature.com/articles/s41598-022-13875-x (2022)
- Neuromod Devices Ltd., Lenire (CR-201) Clinician's Manual,
(2023)
- https://www.nidcd.nih.gov/health/tinnitus
- US VA Benefits Report Fiscal Year
2023: https://www.benefits.va.gov/REPORTS/abr/
- TENT-A3 trial data in preparation for
publication: https://clinicaltrials.gov/study/NCT05227365?intr=lenire&rank=1
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