- The number of audiologists providing Lenire increased to 130 in 70 clinics across the USA and this number is set to grow further throughout 2024.
- Lenire will be expanding the number of clinics in California, Texas, New York, and Florida to address significant demand.
- Tinnitus sufferers in new states such as Oklahoma, North Carolina and many more will now have local access to the groundbreaking tinnitus treatment technology.
- Lenire is the first and only bimodal neuromodulation device approved by the US FDA for the treatment of tinnitus. The device has been proven to be more effective than sound-alone for those with moderate or worse tinnitus in the technology’s pivotal TENT-A3 clinical trial.
Houston, Texas, February 27, 2024: Neuromod Devices, the medical technology company that developed tinnitus treatment device, Lenire, has partnered with an additional 24 new US clinics to address the significant demand for the FDA Approved tinnitus treatment device.
Lenire® is a groundbreaking bimodal neuromodulation device which has been proven to provide clinically significant relief from tinnitus in a clinical trial, and real world settings.1,2,3
Tinnitus, commonly known as “ringing in the ears”, is a complex brain signalling condition that causes people to perceive sound with no external source.
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 Oklahoma, Missouri, North Carolina, and more. As well as this, further clinics will open in states with significant demand such as California, Florida, New York, and Texas.
Founder of Albany, New York-based clinics, Audiologic Solutions, and American Tinnitus Association Board Member, Dr. Erin Walborn Au.D. is excited to offer the FDA Approved device.
"As clinicians, expanding the care we provide to patients within our practice is something we take seriously. Lenire is a fantastic tool to have in our toolbox as tinnitus providers and I am excited to make it available in my practice." said Dr. Walborn, Founder of Audiologic Solutions.
According to the National Institute on Deafness and Other Communication Disorders (NIDCD) approximately 25 million Americans are living with tinnitus,4 2.94 million of whom are Veterans.5 Regardless of the overwhelming prevalence of tinnitus, the condition remains one of the largest unmet clinical needs in the world.
Neuromod Devices aims to change this by working with leading tinnitus care experts in the United States of America and beyond. 130 audiologists in 70 clinics across America will now provide Lenire with further expansion planned through 2024.
"I'm delighted to see more tinnitus experts training to provide treatment with Lenire. Expanding access for patients is important for all of us and we know that putting it in the hands of expert clinicians and training them effectively leads to fantastic outcomes for patients," 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® US FDA’s De Novo Grant was awarded based on the success of Lenire’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 launched in Europe in 2019 on the back of two large-scale clinical trials, TENT-A1 and TENT-A2. These clinical trials represented the largest ever conducted for a tinnitus treatment device and featured the longest follow up timeframe.
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 period1. 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® 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 long term relief from tinnitus.1,2
Lenire is now available in approximately 70 clinics across the US. Tinnitus patients can learn more about Lenire, tinnitus and where to find a clinic nearby 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. 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
5. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/
