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Neuromod Devices - Your Partner for Tinnitus - September 2021

Neuromod Partners with 14 New US Tinnitus Clinics to Expand Availability of FDA Approved Lenire

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  • The number of practice partners providing Lenire across the USA has increased to more than 80 in Lenire’s second US expansion of 2024.
  • Lenire will be expanding the number of clinics in California, Texas, Illinois, and Florida to address significant demand.
  • Tinnitus sufferers in new states such as Alabama, Arkansas and many more will now have local access to the groundbreaking tinnitus treatment technology.
  • Lenire, the first and only bimodal neuromodulation FDA Approved tinnitus treatment device, has been shown to be more effective than sound-alone for those with moderate or worse tinnitus in the technology’s pivotal TENT-A3 clinical trial.

 

Chicago, Illinois, June 12, 2024. Neuromod Devices, the medical technology company that developed tinnitus treatment device, Lenire, has partnered with 14 new US clinics to address the growing demand for the first and only FDA Approved tinnitus treatment device.

Lenire® is a groundbreaking bimodal neuromodulation device which has been proven to provide clinically significant relief from tinnitus in clinical trial and real-world settings.1,2,3

Tinnitus, commonly known as “ringing in the ears”, is a complex brain signaling condition that causes people to perceive sound with no external source.

Lenire has become the most in-demand tinnitus treatment device in America since the device was awarded a De Novo FDA Approval Grant in 2023. Neuromod Devices, creators of Lenire, is operating a phased expansion to prioritize patient care excellence at scale.

This latest expansion will see the clinically proven tinnitus treatment device become available in new states such as Alabama, Oregon, and North Dakota, and more. As well as this, further clinics will open in states with significant demand such as California, Florida, Illinois, and Texas.

Founder of Alabama Hearing Associates, Dr. Susan Sheehy believes that evidence-based Lenire is a “fantastic opportunity” for her patients to get relief from tinnitus.

“Alabama Hearing Associates has worked with tinnitus patients for over twenty-four years. Our clinic firmly believes in offering evidence-based treatment options when managing a patient’s tinnitus journey. For that reason, we are excited to add FDA-approved Lenire to our list of tinnitus services. This is a fantastic new opportunity to help our patients return to the quality of life they had before tinnitus.” Dr. Susan Sheehy, Au.D., Founder of Alabama Hearing Associates.

Tinnitus, which is 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 that at least 25 million Americans6 are currently living with tinnitus. 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

Neuromod Devices aims to change this by working with leading tinnitus care experts in the United States of America and beyond. 144 audiologists in 87 clinics across America are now providing Lenire with further expansion planned through 2024.

"Neuromod’s mission is to create a new standard of care for tinnitus patients, and this goal is achievable only through collaboration with leading hearing and tinnitus care professionals. We are proud to expand Lenire’s accessibility by establishing partnerships with professionals who share Neuromod’s uncompromising patient-centric approach to tinnitus care." said Eric Timm, Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations.

Lenire’s demand is owed to being the first device of its kind to be awarded a De Novo Grant from the US FDA. Lenire’s landmark FDA Approval was awarded following the success of Lenire’s third large-scale clinical trial, TENT-A3.

Lenire’s De Novo submission demonstrated that 70.5% of patients with moderate or worse tinnitus who experienced no clinically meaningful improvement from six weeks of sound-only therapy reported clinically significant improvement in their tinnitus severity following six weeks of treatment with Lenire.1,5  As well as this, the majority of participants who underwent six weeks of sound-only stimulation reported that a further six weeks of treatment with Lenire provided additional benefit for their tinnitus.1,5  

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 treatment1.

Lenire’s 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 events1. These results build upon the success of two previous landmark clinical trials of Lenire that included more than 500 patients.2,3

Lenire® is a bimodal neuromodulation device which works by delivering mild electrical pulses to the tongue, through an intra-oral component called the ‘Tonguetip®’, combined with auditory stimulation through headphones to drive long-term changes in the brain to treat tinnitus. This dual action stimulus is proven to provide effective relief from tinnitus.1

Tinnitus patients can learn more about Lenire, tinnitus and where to find a clinic near their location by visiting www.lenire.com.

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 specializes 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.

References & Notes

  1. Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (2023)
  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. 
  6. https://www.nidcd.nih.gov/health/tinnitus

 

 

 

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