- The American Academy of Otolaryngology – Head and Neck Surgery Foundation has included Lenire (bimodal neuromodulation) as a treatment option for the first time in their Clinical Practice Guidelines for Tinnitus.
- The guidelines have added only one new treatment recommendation since their establishment in 2014: Lenire.
- Lenire is the first and only FDA-approved bimodal neuromodulation tinnitus treatment device.
The American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) has included Lenire (bimodal neuromodulation) as a treatment option in the Academy’s new Clinical Practice Guidelines for Tinnitus.
Since establishing its guidelines in 2014, the AAO-HNSF has added only one new treatment recommendation: bimodal neuromodulation. Building on the FDA’s landmark approval of Lenire (the first and only bimodal neuromodulation device approved by the FDA). AAO-HNSF inclusion further establishes Lenire as a new standard of care for tinnitus in the U.S.A.
The AAO-HNSF guidelines help ENTs across the United States to clinically evaluate and manage tinnitus in everyday care. The guidelines “emphasize interventions and therapies deemed beneficial.” It directs American ENTs “to avoid treatments that are time-consuming, costly, inaccessible, and ineffective”.
“This is 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 included in 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 suffering from tinnitus”.
Lenire Added to AAO-HNSF Guidelines for Tinnitus Based on on Robust Evidence
US ENTs can now confidently recommend Lenire following a review by the Academy’s panel of tinnitus experts.
Lenire combines sound stimulation with mild electrical stimulation to the surface of the tongue (bimodal neuromodulation). This combination soothes and relieves tinnitus. Three large-scale clinical trials¹²³ have demonstrated Lenire’s effectiveness and inherent safety. A growing body of real-world clinical outcomes⁴⁵ continues to validate these findings.
Lenire’s landmark FDA Approval in March 2023 was based on the pivotal TENT-A3 controlled clinical trial and confirmatory real-world evidence. Nature Communications published the results.
Real World Results Support Lenire’s Clinical trial Effectiveness
Tens of thousands of American patients have used Lenire to treat their tinnitus since the U.S. FDA granted the device approval. The company supports these clinicians by publishing this growing body of real-world evidence. This will firmly establish Lenire as a leading standard of care.
Nature Communications Medicine peer-reviewed and published of results of Lenire’s real world evidence paper. The paper demonstrated 91.5% of tinnitus patients had a clinically significant reduction in tinnitus. The American Journal of Audiology published the second real-world retrospective analysis. It reported that 81.8% of patients with bothersome tinnitus reported a clinically significant reduction in tinnitus.
“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” said Neuromod Chief Scientific Officer, Professor Hubert Lim. “Neuromod 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 of America, Canada, Europe, and Australia. It is also a treatment option through the United States of America Veterans Affairs.
About Neuromod Devices
Neuromod Devices is a global medical technology company with offices in Ireland and North America. The company specializes in the design and development of neuromodulation technologies to address the clinical needs of tinnitus patients.
Neuromod has completed 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.
The largest body of clinical research for a tinnitus treatment device supports Lenire. 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 & Lim, Communications Medicine, 2025
- Kasper et al., American Journal of Audiology, 2026
