The American Academy of Otolaryngology - Head and Neck Surgery Foundation has added Lenire (bimodal neuromodulation) as a treatment choice for the first time in their Clinical Practice Guidelines for Tinnitus.
Lenire stands as the sole new treatment suggestion included in the guidelines since they were first set in 2014.
Lenire is the first and only FDA-cleared bimodal neuromodulation device for tinnitus relief.

The American Academy of Otolaryngology - Head and Neck Surgery Foundation (AAO-HNSF) has added Lenire (bimodal neuromodulation) as a treatment choice in the Academy's updated Clinical Practice Guidelines for Tinnitus.

Bimodal neuromodulation represents the only fresh treatment suggestion placed in the AAO-HNSF guidelines since they started in 2014. This builds on the FDA's key clearance of Lenire in 2023 (the first and only bimodal neuromodulation device cleared by the FDA) and further positions Lenire as a fresh standard of care for tinnitus across the U.S.A.

The AAO-HNSF guidelines assist ENTs nationwide in clinically assessing and handling tinnitus during routine care. The guidelines "emphasize interventions and therapies deemed beneficial" and guide American ENTs "to avoid treatments that are time-consuming, costly, inaccessible, and ineffective."

"This marks another historic first for our company, our technology and for the field of tinnitus treatment," said Neuromod Founder, Dr. Ross O'Neill Ph.D. "Lenire being added to the American Academy of Otolaryngology's guidelines means that the 12,000-plus practicing ENTs in the U.S. now have a new safe and effective treatment to recommend to the tens of millions of Americans living with tinnitus."

Strong Evidence Supports American Academy of Otolaryngology Choice on Lenire

US ENTs can now confidently suggest Lenire with the knowledge that it has been examined by the Academy's panel of tinnitus experts.

Lenire pairs sound stimulation with mild electrical stimulation to the tongue surface (bimodal neuromodulation) to ease tinnitus symptoms. Lenire has shown effectiveness and built-in safety in three large clinical trials and gained support from a growing set of real-world clinical results.

Lenire's landmark FDA Clearance in March 2023 rested on the pivotal TENT-A3 controlled clinical trial and supporting real-world data. The outcomes appeared in Nature Communications and rank in the 99th percentile of most-viewed articles tracked by Nature.

Since then, tens of thousands of American patients have received successful treatment with Lenire in clinics nationwide. The company aims to help these clinicians continue publishing this expanding real-world data to firmly position Lenire as a leading standard of care.

Findings in the first peer-reviewed real-world paper published in Nature Communications Medicine showed 91.5 percent of tinnitus patients achieved a clinically meaningful drop in tinnitus. The second real-world retrospective analysis published in The American Journal of Audiology found that 81.8 percent of patients with bothersome tinnitus reported a clinically meaningful drop in tinnitus.

"The addition of bimodal neuromodulation to the AAO-HNSF Clinical Practice Guideline for Tinnitus strengthens the rigorous and large-scale clinical evidence for Lenire as a treatment for patients seeking relief from their bothersome tinnitus" said Neuromod Chief Scientific Officer, Professor Hubert Lim. "Neuromod remains dedicated to further building upon the large evidence base for Lenire to make it more effective and accessible for tinnitus patients worldwide."

Lenire is offered through qualified healthcare professionals in the United States of America, Canada, Europe, and Australia. It also serves as a treatment option through the United States of America Veterans Affairs.

Media Contacts

Europe
Joseph Roche
[email protected]
+353 (87) 416 0138

North America
Kevin Knight
[email protected]
+1 (214) 732-9392

About Neuromod Devices

Neuromod Devices is a global medical technology company with offices in Ireland and North America. The company focuses on the design and development of neuromodulation technologies to meet the clinical needs of tinnitus patients.

Neuromod has finished extensive clinical trials that confirmed the safety and effectiveness of its non-invasive bimodal neuromodulation tinnitus treatment device, Lenire. For more information about Neuromod, visit www.neuromod.com.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device. Bimodal neuromodulation stimulates nerves using two paired stimuli to drive significant relief from tinnitus.

Lenire combines audio stimulation with stimulation to the surface of the tongue that is delivered through a proprietary device trademarked as Tonguetip.

An appropriately qualified healthcare professional, such as an ENT or audiologist, prescribes Lenire following a comprehensive audiological examination. Patients then complete treatment as advised from the comfort of their own home.

Lenire is backed by the largest volume of clinical research for a tinnitus treatment device. This research has been validated in peer-reviewed and published analyses of tinnitus patients treated with Lenire at independent clinics.

Lenire has CE-mark certification and is the first and only bimodal neuromodulation to be awarded a De Novo Approval Grant from the US FDA.

References

Conlon et al., Science Translational Medicine, 2020 (TENT-A1)
Conlon et al., Scientific Reports, 2022 (TENT-A2)
Boedts et al., Nature Communications, 2024 (TENT-A3)
McMahan and Lim, Communications Medicine, 2025
Kasper et al., American Journal of Audiology, 2026