Lenire Included in New Tinnitus Guidelines

DUBLIN, Oct. 16, 2026 /CourierPR/ -- The American Academy of Otolaryngology, Head and Neck Surgery Foundation (AAO-HNSF) has included Lenire (bimodal neuromodulation) as a treatment option for the first time in their Clinical Practice Guidelines for Tinnitus. Lenire is the only new treatment recommendation added to the guidelines since their establishment in 2014. The AAO-HNSF guidelines, which help ENTs across the United States to clinically evaluate and manage tinnitus in everyday care, emphasize interventions and therapies deemed beneficial and direct American ENTs to avoid treatments that are time-consuming, costly, inaccessible, and ineffective.

This inclusion marks another historic first for Neuromod Devices, the company behind Lenire, and the field of tinnitus treatment. The AAO-HNSF guidelines now recognize Lenire as a new standard of care for tinnitus in the United States, following the landmark FDA approval of the device in March 2023, which was based on the pivotal TENT-A3 controlled clinical trial and confirmatory real-world evidence published in Nature Communications.

The inclusion of bimodal neuromodulation in the AAO-HNSF Clinical Practice Guideline for Tinnitus reinforces the rigorous and large-scale clinical evidence for Lenire as a treatment for patients seeking help for their bothersome tinnitus. The guidelines underscore the effectiveness and safety of Lenire, a non-invasive bimodal neuromodulation tinnitus treatment device that combines sound stimulation with mild electrical stimulation to the surface of the tongue.

Since its FDA approval, tens of thousands of American patients have been successfully treated with Lenire in clinics across the United States. The company plans to support these clinicians in publishing this growing body of real-world evidence to firmly establish Lenire as a leading standard of care. Results from the first peer-reviewed real-world paper published in Nature Communications Medicine reported that 91.5% of tinnitus patients had a clinically significant reduction in their condition. A second real-world retrospective analysis published in The American Journal of Audiology reported that 81.8% of patients with bothersome tinnitus reported a clinically significant reduction in their symptoms.

Neuromod Devices, the company behind Lenire, has completed extensive clinical trials that confirmed the safety and effectiveness of its non-invasive bimodal neuromodulation tinnitus treatment device. The company is committed to further expanding upon the large evidence base for Lenire to make it more effective and accessible for tinnitus patients worldwide. Lenire is available via qualified healthcare professionals in the United States, Canada, Europe, and Australia, and is also a treatment option through the United States of America Veterans Affairs.

The inclusion of bimodal neuromodulation in the AAO-HNSF Clinical Practice Guideline for Tinnitus reinforces the rigorous and large-scale clinical evidence for Lenire as a treatment for patients seeking help for their bothersome tinnitus. The guidelines emphasize interventions and therapies deemed beneficial, directing American ENTs to avoid treatments that are time-consuming, costly, inaccessible, and ineffective. Lenire is the only new treatment recommendation added to the AAO-HNSF guidelines since their establishment in 2014.