The American Academy of Otolaryngology - Head and Neck Surgery Foundation has included Lenire bimodal neuromodulation as a treatment option in its tinnitus clinical practice guidelines for the first time.
Lenire is the only new treatment recommendation added to the guidelines since they were established in 2014.
Lenire from Neuromod Devices is the first and only FDA-approved bimodal neuromodulation device for tinnitus treatment.

PRNewswire -- The American Academy of Otolaryngology-Head and Neck Surgery Foundation has added Lenire bimodal neuromodulation as a treatment option in its new tinnitus clinical practice guidelines.

Bimodal neuromodulation is the sole new treatment recommendation added to the AAO-HNSF guidelines since their creation in 2014. Building on Lenire's historic FDA approval in 2023 as the first and only FDA-cleared bimodal neuromodulation device, Lenire is solidifying its role as a new standard of care for tinnitus in the United States.

The AAO-HNSF guidelines assist US otolaryngologists in evaluating and clinically managing tinnitus in daily practice. These guidelines emphasize interventions and treatments considered beneficial and urge American ENT specialists to avoid lengthy, costly, inaccessible and ineffective treatments.

This marks another historic first for our company, our technology and the tinnitus treatment field, said Neuromod founder Dr. Ross O'Neill. Inclusion of Lenire in the American Academy of Otolaryngology guidelines means that more than 12,000 ENT physicians practicing in the United States 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 Decision on Lenire

US otolaryngologists can now confidently recommend Lenire knowing it has been reviewed by the Academy's expert tinnitus committee.

Lenire pairs sound stimulation with mild electrical stimulation on the tongue surface through bimodal neuromodulation to relieve tinnitus symptoms. Lenire has shown strong efficacy and inherent safety across three large-scale clinical trials and has been validated by a growing body of real-world clinical outcomes.

Lenire's historic FDA approval in March 2023 was based on the pivotal controlled TENT-A3 clinical trial and confirmatory real-world evidence. Results were published in Nature Communications and rank in the 99th percentile of most-viewed articles tracked by Nature.

Since then Lenire has successfully treated tens of thousands of American patients in clinics across the United States. The company plans to help these healthcare professionals continue publishing this expanding body of real-world evidence to firmly establish Lenire as a leading standard of care.

Results from the first peer-reviewed real-world study published in Nature Communications Medicine reported clinically significant tinnitus reduction in 91.5 percent of patients. The second retrospective real-world analysis published in The American Journal of Audiology indicated that 81.8 percent of patients with bothersome tinnitus reported clinically significant tinnitus reduction.

Inclusion of bimodal neuromodulation in the AAO-HNSF tinnitus clinical practice guidelines reinforces the rigorous large-scale clinical evidence for Lenire as a treatment for patients seeking relief from debilitating tinnitus, said Neuromod chief scientific officer Professor Hubert Lim. Neuromod is committed to deepening the extensive evidence base for Lenire to make it more effective and accessible to tinnitus patients worldwide.

Lenire is available from qualified healthcare professionals in the United States, Canada, Europe and Australia. It is also a therapeutic option offered by the US Department of Veterans Affairs.

About Neuromod Devices

Neuromod Devices is an international 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 patients with tinnitus.

Neuromod has completed extensive clinical trials confirming the safety and efficacy of its non-invasive bimodal neuromodulation device Lenire for tinnitus treatment. For more information on 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 deliver significant tinnitus relief.

Lenire combines auditory stimulation and tongue-surface stimulation both delivered via a proprietary Tonguetip device.

Lenire is prescribed by a qualified healthcare professional such as an ENT or audiologist following a comprehensive hearing assessment. Patients then complete treatment as scheduled in the comfort of their home.

Lenire is backed by the largest number of clinical studies dedicated to a tinnitus treatment device. These research efforts have been validated through peer-reviewed analyses published on patients treated with Lenire in independent clinics.

Lenire is CE marked and is the first and only bimodal neuromodulation system to receive FDA De Novo authorization.

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 et Lim, Communications Medicine, 2025
Kasper et al., American Journal of Audiology, 2026