AAO-HNSF adds Lenire to tinnitus guidelines, the only new recommendation since 2014

The American Academy of Otolaryngology–Head and Neck Surgery Foundation has included Lenire as a treatment option in its new Clinical Practice Guidelines for Tinnitus.¹ The announcement characterizes bimodal neuromodulation as the sole new treatment recommendation added to the guidelines since they were established in 2014.¹ That description makes the change specific: it is an addition to the guideline’s treatment options, rather than a claim that tinnitus care as a whole has been replaced.¹ The announcement is dated October 16, 2026, and carries a Dublin dateline.¹

The guidelines are intended to help ear, nose and throat specialists in the United States assess and manage tinnitus in routine clinical practice.¹ They highlight interventions and therapies regarded as beneficial, while advising ENTs to avoid options described as burdensome in time or cost, difficult to access, and ineffective.¹ Lenire’s inclusion therefore places it among the options considered in this guidance for clinicians, according to the announcement.¹ The release says U.S. ENTs may recommend the device following consideration by the Academy’s panel of tinnitus experts.¹

Neuromod founder Ross O’Neill said the addition gives more than 12,000 practicing ENTs in the United States a further treatment they can recommend to Americans with tinnitus.¹ The figure refers to practicing U.S. ENTs, not to the number of patients treated or to an estimate of people who will use Lenire.¹ The announcement also says tens of thousands of American patients have received Lenire in U.S. clinics since FDA approval.¹ That patient count describes treatment already reported by the company, while the ENT figure describes clinicians who could recommend the device under the guidelines.¹

Lenire uses two forms of stimulation: sound and mild electrical input delivered to the tongue’s surface.¹ The release also describes it as non-invasive and identifies Tonguetip as the device used to provide stimulation at the tongue.¹ These descriptions explain what the announcement means by bimodal neuromodulation: the treatment pairs audio with tongue stimulation.¹ The release says a qualified professional, including an ENT or audiologist, prescribes Lenire after a comprehensive audiological examination, and patients carry out treatment at home as advised.¹

The announcement says the FDA approved Lenire in 2023 and describes it as the first and only bimodal neuromodulation device to receive that approval.¹ It specifies that the approval came in March 2023 and rested on the controlled TENT-A3 clinical trial together with confirmatory evidence from real-world use.¹ The release says Lenire has also undergone three large-scale clinical trials and evaluation through real-world clinical outcomes.¹ The guideline addition thus follows the approval and reported testing described in the announcement; it is not presented there as the date Lenire first became available.¹

TENT-A3 results appeared in Nature Communications, according to the release, which says Nature ranked the article in the 99th percentile for views among tracked articles.¹ The announcement also cites a first peer-reviewed paper based on real-world clinical use, reporting a clinically significant tinnitus reduction for 91.5% of patients.¹ A second retrospective analysis reported that 81.8% of patients described as having bothersome tinnitus experienced a clinically significant reduction.¹ Those two percentages are reported for separate studies and patient descriptions, so the announcement does not present them as one pooled result.¹

Neuromod says it intends to help clinicians publish additional real-world evidence about Lenire.¹ The company’s chief scientific officer said inclusion in the guidelines strengthens the case made by the clinical evidence and that Neuromod plans to broaden the evidence base.¹ The release lists five studies, extending from TENT-A1 in 2020 to an analysis published in the American Journal of Audiology in 2026.¹ The release’s account therefore includes both earlier trial work and later research, while also describing further evidence publication as a company plan.¹

Lenire is available through qualified healthcare professionals in the United States, Canada, Europe and Australia, the release says.¹ It also identifies the device as a treatment option through Veterans Affairs in the United States.¹ The release says Lenire holds CE-mark certification as well as a De Novo Approval Grant from the U.S. FDA, and repeats its description of the device as the first and only of its bimodal type to receive FDA authorization.¹ Availability across several regions and through Veterans Affairs describes routes named in the announcement; it does not change the clinical examination and prescription process it sets out.¹

Neuromod Devices says it operates internationally, with offices in Ireland and North America, and develops neuromodulation technologies for tinnitus patients.¹ The announcement was distributed through PR Newswire, and a second numbered source repeats the same guideline inclusion and claims about clinical evidence and availability.¹ That repetition does not supply a separate guideline decision or a second set of clinical results; the second source reproduces the same announcement’s account.¹ The central change reported is the guideline recognition of Lenire as an option, alongside an existing approval, reported clinical evidence, and a clinician-led route to treatment.¹