- 'Textbook of Tinnitus' is a comprehensive textbook
that describes tinnitus, how it is caused, and state-of-the art
interventions such as Lenire.
- Top-ranked tinnitus expert authors of the Textbook of
Tinnitus state that Lenire's clinical trial results are
remarkable and demonstrate results not seen in any other accepted
tinnitus care intervention.
- 91% of patients in Lenire's second large-scale clinic
trial, TENT-A2, reported long-term relief from tinnitus that lasted
at least 12-months.[2]
- Lenire has been proven to be more effective than sound-alone
for patients with moderate or worse tinnitus in Lenire's controlled
large-scale clinical trial, TENT-A3.[3]
- Lenire was awarded a De Novo Grant from the US FDA, making it
the first and only FDA Approved bimodal neuromodulation tinnitus
treatment device.
DUBLIN, April 29, 2024 /PRNewswire/ -- Lenire, the first
and only FDA approved bimodal neuromodulation device for the
treatment of tinnitus, has been included in the seminal
"Textbook of Tinnitus," Second Edition. Inclusion in
the "Textbook of Tinnitus" further validates bimodal
neuromodulation as a tinnitus treatment methodology while
positioning Lenire as the technological standard bearer.
Lenire® is a bimodal neuromodulation device which has been
proven to provide long term relief from tinnitus that lasts for at
least 12-months after treatment in large scale clinical
trials.[1],[3] Lenire's bimodal neuromodulation works by
delivering mild pulses to the tongue, through an intra-oral
component called the Tonguetip®. To treat tinnitus, it works
in concert with auditory stimulation through headphones to promote
long-term changes in the brain.
In Lenire's most recent controlled clinical trial, the device
was shown to be more effective than sound-alone for those with
moderate or worse tinnitus.[3]
Tinnitus, commonly known as "ringing in the
ears," is a complex brain signalling condition that causes
people to perceive sound with no external source. An estimated 15%
of the global adult population is impacted by tinnitus.
"The Textbook of Tinnitus, Second Edition"
is a comprehensive source of knowledge on the subject of tinnitus,
types of tinnitus, causes of tinnitus, and available treatments.
The textbook's Bimodal Neuromodulation chapter is authored by top
ranked tinnitus expert, Berthold
Langguth[5], and third ranked tinnitus expert,
Sven Vanneste[5] per
ExpertScape. The chapter was peer-reviewed by a panel of
leading tinnitus experts, demonstrating expert consensus of Lenire
as the standard bearer for bimodal neuromodulation.
"Innovative medical technology undergoes a journey from
validation through clinical research to becoming a standard of
care. Inclusion in the 'Textbook of Tinnitus' is the latest
indication Lenire is the category defining standard of care for
tinnitus treatment," said Dr. Ross O'Neill, Neuromod's Founding CEO.
"The Textbook of Tinnitus" Bimodal Neuromodulation
chapter cites Lenire's "remarkable" clinical trial results and
compares the data to cognitive behavioural therapy, a preeminent
accepted standard of tinnitus care.
"This is remarkable, as such long-term improvement has not
been demonstrated for any other treatment, not even cognitive
behavioural therapy." Sven Vanneste and Berthold Langguth, "Textbook of
Tinnitus," Chapter 54 on Lenire's Large-Scale Clinical
Trials.
Speaking on Lenire's inclusion in the "Textbook of
Tinnitus," Dr. Gail Whitelaw PhD, Director of the
Speech-Language-Hearing Clinic at the Ohio
State University, said, "The Tinnitus Textbook is a
valuable centralized repository of tinnitus information. Bimodal
neuromodulation's inclusion demonstrates its credibility as a
treatment for tinnitus with Lenire specifically leading the way in
clinical application."
The first of Lenire's clinical trials, TENT-A1, represents one
of the largest and longest followed-up clinical trials ever
conducted in the tinnitus field and was the cover story for the
top-tier peer reviewed scientific journal, Science Translational
Medicine. The trial enrolled 326 participants and 86.2% of
compliant participants reported an improvement in their tinnitus
severity after a 12-week treatment period.[1] When
followed up with 12 months post treatment, 80.1% of compliant
participants had sustained improvement.[1]
Results from Lenire's second large-scale clinical trial,
TENT-A2, were published in the prestigious scientific journal,
Nature – Scientific Reports. TENT-A2 data demonstrated that
modifying stimuli halfway through treatment resulted in a greater
clinically significant improvement in tinnitus
severity.[2] 95% of compliant patients reported a
tinnitus improvement, 91% of whom reported a sustained improvement
for a year after the treatment ended.[2]
Lenire recently became the first device of its kind to be
awarded a De Novo Grant from the US FDA based on the success of the
device's third large-scale clinical trial, TENT-A3. During this
controlled clinical trial, 79.4% of the patients had a clinically
significant reduction in tinnitus severity and 88.6% responded that
they would recommend Lenire®.[3] Importantly, Lenire®
was proven to be more effective than sound-only therapy for 70.5%
of patients with moderate and above tinnitus.[3]
TENT-A3's landmark results are set for publication in an
independent scientific journal in 2024.
Lenire is available through leading hearing and tinnitus care
clinics in the United States of
America, Europe, and the
United Kingdom. Neuromod's
sophisticated practice-enablement approach has ensured the highest
level of patient care at scale that has led to real world results
that closely match clinical trial data.
Lenire's remarkable clinical trial results, category-defining
regulatory approval, strong real world effectiveness at a global
scale, and inclusion in the prestigious Textbook of Tinnitus
positions the bimodal neuromodulation device as the new standard
for tinnitus care.
Learn more about tinnitus, bimodal neuromodulation and the
availability of groundbreaking tinnitus treatment device, Lenire,
at www.lenire.com.
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.
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.
About The Textbook of Tinnitus, Second Edition
The Textbook of Tinnitus, Second Edition describes the
theoretical background of the different forms of tinnitus (ringing
in the ears) and detailed knowledge of state-of-the-art treatments
of tinnitus.
Tinnitus research has dramatically improved since the
publication of the Textbook of Tinnitus, First Edition in 2011. In
view of the substantial increase in knowledge, most chapters in
Textbook of Tinnitus, Second Edition are newly written and a few
original chapters have had major updates.
Textbook of Tinnitus is primarily concerned with equipping
otolaryngologists, neurologists, psychiatrists, neurosurgeons,
primary care clinicians, audiologists and psychologists, and
students with comprehensive and contemporary tinnitus
knowledge.
References and Notes
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. TENT-A3 clinical trial data in preparation for
publication. https://clinicaltrials.gov/ct2/show/NCT05227365 4.
https://www.nidcd.nih.gov/health/tinnitus.
4. R. Biswas et al., Tinnitus prevalence in
Europe: a multi-country
cross-sectional population study, The Lancet Regional Health
(2021), https://doi.org/10.1016/j.lanepe.2021.100250.
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