The US Food and Drug Administration (FDA) has just granted de novo approval to Lenire®, a non-invasive 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.
With Tinnitus being 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% to 25% 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 an estimated $660 per patient per year for visits to clinics alone.
What is Lenire®?
Lenire is a non-invasive 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. 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.
Through three large-scale trials, 83% 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.

Dr. Emily 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 that is 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!
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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