Lenire Tinnitus Device Joins U.S. ENT Guidelines as an Option Doctors May Offer for Bothersome Ringing

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The guideline, from the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF), was published Oct. 12 in the journal Otolaryngology-Head and Neck Surgery.

The academy’s patient flowchart says clinicians “may recommend bimodal neuromodulation” for adults with persistent, bothersome tinnitus. The guideline grades it an “option,” its lowest level of positive recommendation, below “recommendation” and “strong recommendation,” according to a summary of the guideline’s key action statements. That signals a choice for some patients, not a first-line treatment for everyone.

More than 50 million people in the United States have reported experiencing tinnitus, according to the academy. For them, the change adds a device-based choice to a short list of evidence-backed approaches. It does not replace hearing evaluations, counseling, or cognitive behavioral therapy.

Neuromod Devices, the Irish company that makes Lenire, announced the inclusion Oct. 16 in a news release. The company described Lenire as “the only new treatment recommendation” the academy has added since its tinnitus guideline was established in 2014. Separately, the release called the device “a new standard of care,” a description it tied to Lenire’s 2023 FDA authorization rather than to the guideline.

The guideline materials support a narrower reading. Bimodal neuromodulation is one of five new topics in the update, alongside self-harm screening, somatosensory tinnitus, cochlear implantation, and follow-up. The update also added a recommendation to refer some patients for cochlear implant evaluation, which complicates the company’s framing. The academy’s materials do not use the phrase “standard of care.”

“This is another historic first for our company, our technology and for the field of tinnitus treatment,” Neuromod founder Ross O’Neill said in the release.

The update replaces the academy’s 2014 guideline and contains 16 key action statements for adults whose tinnitus has lasted six months or longer and affects quality of life. It was led by Dr. Meredith E. Adams, chair of the guideline update group.

“Every patient with tinnitus should receive a comprehensive hearing evaluation,” Adams said, News-Medical reported from the academy’s announcement. She also urged clinicians to ask directly about emotional distress and thoughts of self-harm.

The guideline supports patient education and counseling, hearing aid evaluation for people with hearing loss, sound enrichment and cognitive behavioral therapy. It recommends against routinely using medications, dietary supplements, or repetitive transcranial magnetic stimulation for tinnitus, and limits imaging to patients with concerning features such as tinnitus in one ear or a pulsing sound.

Lenire received FDA authorization in March 2023. Its main study, TENT-A3, published in Nature Communications in 2024, enrolled 112 adults at three sites, according to The Hearing Review.

Participants first used sound-only therapy for six weeks, then sound plus tongue stimulation for six weeks. Among people with moderate or worse tinnitus who did not improve meaningfully with sound alone, 70.5% reported clinically significant improvement after six weeks of combined treatment, The Hearing Review reported. No device-related serious adverse events were reported.

The trial had no separate placebo or sham group running at the same time, and Neuromod sponsored it. Because every participant received sound therapy first and the device second, some improvement could reflect time, attention, or the natural tendency of symptoms to ease, factors a randomized sham-controlled design is built to rule out.

Long-term durability is also uncertain. “How durable are the effects? We don’t really know yet,” said audiologist Marc Fagelson, chair of the American Tinnitus Association’s scientific advisory committee, in a 2024 interview with NPR. The American Tinnitus Association is one of the groups that endorsed the new guideline.

One patient told NPR she paid about $4,000 for Lenire and that insurance did not cover it. The device is available through trained audiologists and ENT clinics, and the company says it is also offered through the Department of Veterans Affairs. Tinnitus is the most common service-connected disability among veterans, according to the academy’s announcement of the updated guideline.

Treatment involves daily hour-long sessions over several weeks with a mouthpiece and headphones, plus fitting and follow-up visits with a trained clinician. That commitment may suit some people but not others, especially those with limited time, dental or jaw problems, or difficulty using devices.

Anyone with new or worsening tinnitus should start with a clinician visit and a full hearing test. Tinnitus in only one ear, pulsing that matches the heartbeat, sudden hearing loss, dizziness, or facial weakness need prompt medical evaluation, since these can signal a different underlying problem.

People already living with persistent tinnitus can ask an ENT or audiologist which options fit them, including hearing aids, sound therapy, and cognitive behavioral therapy. Before buying Lenire, patients can ask about total cost, refund policies, follow-up visits, and what improvement to expect.

Tinnitus can affect sleep and mood, and up to one-third of patients may have significant depressive symptoms, according to the academy. Anyone having thoughts of self-harm can call or text the 988 Suicide and Crisis Lifeline. Independent trials with sham controls and longer follow-up would help show how much of Lenire’s benefit comes from the device itself and how long it lasts.

The AAO-HNSF updated its tinnitus guideline Oct. 12, 2026. It grades bimodal neuromodulation, the technology used by Lenire, as an option clinicians may offer.

The company uses that phrase, but the guideline grades the treatment as an option, its lowest level of positive recommendation, which signals a choice for some patients rather than a first-line treatment.

It plays sounds through headphones while a mouthpiece delivers mild electrical stimulation to the tongue, usually in daily hour-long sessions.

In a 112-person company-sponsored trial, 70.5% of patients with moderate or worse tinnitus who did not improve with sound alone reported meaningful improvement after six weeks of combined treatment. There was no concurrent sham group.

One patient told NPR she paid about $4,000 without insurance coverage. The company says it is also available through the VA.

What other tinnitus treatments does the guideline support?

Hearing evaluations, counseling, hearing aids for people with hearing loss, sound enrichment, and cognitive behavioral therapy.