- FDA approval for the groundbreaking tinnitus treatment device,
Lenire, was granted in March 2023
based on the success of the device's large-scale controlled
clinical trial, TENT-A3.[1]
- TENT-A3 demonstrated that Lenire is more
effective at providing relief from bothersome
tinnitus than sound therapy alone, which was the
trial's control.
- No device-related serious adverse events were detected during
TENT-A3.[1]
- 88.6% of participants stated they would recommend
Lenire to treat
tinnitus.[1]
- Lenire is available through specialized clinics in
the United States of America and
Europe. Further details
about Lenire® can be found
at www.lenire.com.
CHICAGO, Aug. 20,
2024 /PRNewswire/ -- Nature Communications has
published the peer-reviewed results of Neuromod Devices' TENT-A3
(Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3)
clinical trial for the first and only FDA-Approved bimodal tinnitus
treatment device, Lenire.
The results published in the clinical trial paper titled:
Combining sound with tongue stimulation for the treatment of
tinnitus: a multi-site single-arm controlled pivotal trial,
were central to Lenire's successful De Novo US FDA Grant
approval.
The published paper is available at:
https://www.nature.com/articles/s41467-024-50473-z
Lenire is a bimodal neuromodulation device which has been shown
to provide relief from tinnitus that can sustain for at least
12-months after treatment in large-scale clinical
trials.[2],[3] Lenire's bimodal neuromodulation pairs
mild electrical pulses to the tongue through an intra-oral
component called the Tonguetip® with auditory
stimulation through headphones.
TENT-A3, Neuromod's third large-scale clinical trial for Lenire,
was a controlled trial conducted as part of Lenire's De Novo
submission to the US FDA at three independent sites between March
and October 2022 with 112 enrolled
participants.
TENT-A3 compared Lenire's bimodal neuromodulation mechanism to
sound therapy. The trial was designed and executed with guidance
from the US FDA. Participants were given six weeks of sound-only
stimulation as a control condition, followed by six weeks of
bimodal treatment where tongue stimulation was added to the sound
component.
As part of Lenire's successful De Novo submission, Neuromod was
required to demonstrate that Lenire's bimodal neuromodulation
provided additional clinically significant benefit for tinnitus
when compared to sound-only stimulation. TENT-A3 demonstrated that
Lenire is clinically superior to sound-only stimulation for the
majority of patients with moderate or worse tinnitus.
Clinical trial data from Lenire's De Novo submission further
showed that 70.5% of participants with moderate or worse tinnitus
who experienced no clinically meaningful improvement from six weeks
of sound-only stimulation reported clinically significant
improvement in their tinnitus severity following six weeks of
treatment with Lenire.[5],[7]
The majority of participants with moderate or worse tinnitus who
underwent six weeks of sound-only stimulation also reported that a
further six weeks of treatment with Lenire provided additional
benefit for their tinnitus.[1][5]
Tinnitus, commonly known as 'ringing in the ears', is a complex
neurological condition that causes a perception of sound when there
is no external source. It is estimated at least 25 million
Americans[6] are currently living with the condition.
Tinnitus is also the most prevalent service-connected disability
compensated for by The United States Veterans Administration (VA),
with more than 2.9 million veterans compensated in
2023.[4]
"Tinnitus is the largest unmet need in hearing healthcare,"
said Neuromod Founding CEO, Dr. Ross O'Neill Ph.D., "Historically,
tinnitus patients have been disappointed and frustrated by products
that are neither backed by compelling clinical evidence, nor
cleared by regulatory authorities. With the success of TENT-A3 and
the first-of-its-kind De Novo FDA-Approval, Lenire is the only
tinnitus treatment backed by multiple large-scale clinical trials
and approved by the US Food and Drug Administration."
In addition to the majority of participants benefitting from
bimodal neuromodulation, 82.4% were compliant to bimodal treatment
and 88.6% responded that they would recommend Lenire as a tinnitus
treatment[1].
"Lenire's FDA Approval combined with the rigorous design of
the device's controlled clinical trial were compelling factors when
choosing to add Lenire to the treatment options at my clinic.
said Prof. Gail Whitelaw Ph.D., Clinic Director, Department of
Speech and Hearing Science, The Ohio State
University. "Lenire has been a landmark addition to my
tinnitus toolbox and my patients have seen the benefits of
overwhelmingly positive results."
The positive efficacy, compliance, and safety findings for
TENT-A3 were highly consistent with the real-world evidence from
204 patients included in Lenire's successful De Novo submission to
the US FDA. Across TENT-A3 and the Real-World Evidence, Lenire
proved to be inherently safe with zero device-related serious
adverse events[1]. These results build upon the success
of two previous landmark clinical trials of Lenire that included
more than 500 patients.[2],[3]
"The TENT-A3 controlled clinical trial was properly designed
with expert guidance from the US FDA." said Neuromod Chief
Scientific Officer and University of
Minnesota Professor, Prof. Hubert
Lim, Ph.D., "This interactive collaboration enabled the
success of Lenire's De Novo FDA approval, which has further
established Lenire as a category-defining tinnitus
intervention."
Media Contact
Kevin Knight
kknightpr@gmail.com
+1 (214) 732-9392
About Neuromod
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.
Bimodal neuromodulation is the stimulation of nerves with two
paired stimuli for therapeutic purposes. The tinnitus treatment
device that was used in the study, known as Lenire was developed by
Neuromod. It consists of wireless (Bluetooth®)
headphones that deliver sequences of audio tones to both ears,
combined with electrical stimulation pulses delivered to the
surface of the tongue via 32 electrodes on a proprietary device
trademarked as Tonguetip®. The device's settings can be
configured to provide treatment with different combinations of
audio and electrical stimuli.
The timing, intensity and delivery of the stimuli are controlled
by an easy-to-use handheld controller that each participant is
trained to use prior to continuing treatment from home. Patients
with tinnitus are prescribed Lenire by an appropriately qualified
healthcare professional, such as an Audiologist or ENT Surgeon,
after an assessment for suitability and can complete treatment from
home in between follow-up appointments with their clinician.
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. Lenire is
available in more than 100 specialized clinics across the United States of America, Europe and the United Kingdom. Further details about Lenire®
including a list of providers can be found at www.lenire.com.
References and Notes
- Boedts M, B. A., Khoo G, et al. Combining sound with tongue
stimulation for the treatment of tinnitus: a controlled pivotal
trial. Nature communications (2024)
2. Conlon et al., Sci. Transl. Med. 12, eabb2830
(2020)
3. 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)
4. US VA Benefits Report Fiscal Year
2023: https://www.benefits.va.gov/REPORTS/abr/
5. As measured by Tinnitus Handicap Inventory (THI). THI is
the most widely used clinical standard for measuring the impact of
tinnitus on someone's day-to-day life. The THI is a validated
instrument that is measured on a scale of 100, the higher the
score, the greater the impact of tinnitus. THI scores are
categorized into five severity levels: slight, mild, moderate,
severe and catastrophic. Patients that are at least moderately
affected by their tinnitus have a THI score of 38 and above and
fall into the moderate, severe and catastrophic categories.
https://www.nidcd.nih.gov/health/tinnitus
6. https://www.nidcd.nih.gov/health/tinnitus
7. Neuromod Devices Ltd., Lenire (CR-201) Clinician's Manual,
(2023)
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