Academy lists device in new guidance
The American Academy of Otolaryngology – Head and Neck Surgery Foundation has included Lenire, a bimodal neuromodulation device made by Neuromod Devices, as a treatment option in the academy's new Clinical Practice Guidelines for Tinnitus. The academy's guidance is used by ear, nose and throat specialists across the United States to assess and manage tinnitus in everyday care.
Only new recommendation since 2014
Bimodal neuromodulation is the only new treatment recommendation added to the guidelines since they were established in 2014, the company said.
How the treatment works
Lenire pairs sound stimulation with mild electrical stimulation applied to the surface of the tongue. According to the company, it is the first and only bimodal neuromodulation device to receive FDA approval, granted in March 2023.
Evidence cited and where it is sold
Neuromod said the device has been studied in three large clinical trials and in real-world analyses, including a peer-reviewed paper reporting that 91.5% of tinnitus patients had a clinically significant reduction in symptoms and a second retrospective analysis reporting 81.8%. Ross O'Neill, the company's founder, said the guideline inclusion means more than 12,000 practicing ENTs in the United States can now recommend a new treatment. Lenire is available through qualified healthcare professionals in the United States, Canada, Europe and Australia, and as a treatment option through the US Veterans Affairs system, the company said.
