The US Food and Drug Administration (FDA) has just granted De Novo approval for Lenire®, a noninvasive device developed by Neuromod Devices Ltd. to treat tinnitus. This is the first bimodal neuromodulation device of its kind to be approved by the FDA for tinnitus treatment in the US market.
This is BIG news for the 25,000,000 Americans suffering from tinnitus.
Tinnitus is a complex neurological condition that causes a perception of sound when there is no external source, commonly known as “ringing in the ears.” It is estimated that between 8 and 25 percent of Americans are currently suffering from tinnitus, and among them, 2.7 million are veterans.
Tinnitus is a silent burden on the US national healthcare system, estimated to cost $660 per patient per year for visits to clinics alone.
However, with this revolutionary FDA-approved treatment, those dealing with tinnitus can finally see lasting relief from their symptoms.
What is Lenire®, and How Does It Work?
Lenire is a noninvasive medical device that uses bimodal neuromodulation to treat tinnitus. The device delivers mild pulses to the tongue, combined with sound played through headphones, to reduce tinnitus severity. With this revolutionary dual stimulation method, you retrain your brain to focus on other stimuli so it doesn’t focus on the noises associated with tinnitus.
Through a prescribed treatment plan, you use the Lenire controller (a lightweight handheld device) that controls the timing and intensity of the treatment, adjusting the sound volume and tongue stimulation level.
Lenire vs. Other Tinnitus Treatments
Lenire is unique due to the Tonguetip, which delivers the oral stimulation to your tongue, effectively working in tandem with the noise-canceling headphones that play soft, soothing sound therapies.
While other tinnitus treatments, like tinnitus retraining therapy (TRT) or sound therapy, can work for some, the relief can be short lasted. Lenire’s dual stimulation method works to retrain your brain to focus on the sound and oral stimuli instead of the ringing in your ears.
Incredible Results of Lenire—Clinical Trials
Through three large-scale trials, 83 percent of more than 500 trial patients would recommend Lenire to treat tinnitus. The device’s most recent clinical trial was designed to meet the FDA’s rigorous requirements and showed improvements in tinnitus severity consistent with data from real-world patients in Europe.
During these clinical trials, an incredible 95 percent of patients reported improvement when they were evaluated after just 12 weeks of using Lenire’s treatment procedure.
Dr. Emily E. McMahan One of Just 15 Healthcare Professionals to Offer This Revolutionary Treatment Solution
I am proud to announce that I am one of just 15 healthcare professionals in the USA trained and qualified to offer this revolutionary solution for tinnitus treatment. I’m so excited to bring this cutting-edge tinnitus solution to my patients, and the people of Alaska!
Thanks to the remarkable clinical results of Lenire, the hearing healthcare industry can expect to see a huge rise in success for personalized tinnitus treatment. With its painless approach, customizable levels of stimulation, and effective results, Lenire is a game-changer for those dealing with tinnitus.
Where Can I Get Lenire Treatment?
With what is anticipated to be a large demand, if you would like to register your interest in Lenire, then please call us at (907) 522-4357.
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