Dublin, Ireland, and Alexandria, Virginia, USA, October 16, 2026
Neuromod Devices has announced that its Lenire® bimodal neuromodulation device has been included as a treatment option in the updated clinical practice guidelines for tinnitus issued by the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF). Published in October 2026, the updated guidelines provide evidence-based recommendations to help healthcare professionals evaluate and manage adults experiencing persistent, bothersome tinnitus. The inclusion represents an important development in medical technology for hearing health, as Lenire is the only new treatment recommendation highlighted by the company since the Academy first established its tinnitus guidelines in 2014. Lenire received U.S. Food and Drug Administration (FDA) De Novo authorization in March 2023, and its addition to the updated guidelines reflects growing clinical interest in non-invasive neuromodulation approaches. The development may help ear, nose and throat specialists and other qualified healthcare professionals consider additional options when discussing tinnitus management with appropriate patients.
Lenire Combines Sound and Tongue Stimulation
Lenire uses bimodal neuromodulation, a treatment approach that combines two forms of stimulation: auditory stimulation delivered through headphones and mild electrical stimulation applied to the surface of the tongue through a proprietary component known as Tonguetip®. The device is designed to help reduce the perceived severity and impact of tinnitus, a condition in which individuals hear sounds such as ringing, buzzing or humming without an external sound source. Tinnitus can interfere with sleep, concentration, emotional well-being and everyday activities, particularly when symptoms persist over extended periods. Unlike medicines that act through systemic pharmacological pathways, Lenire uses paired sensory stimulation to influence neural activity associated with tinnitus. Treatment is prescribed following a comprehensive audiological assessment by a qualified healthcare professional, such as an audiologist or ear, nose and throat specialist. Patients then use the device according to their prescribed treatment plan, typically at home. The inclusion in the updated guidelines gives clinicians another evidence-supported option to consider, although suitability depends on individual symptoms, clinical assessment and the recommendations contained in the full guideline.
Clinical Evidence Supports Tinnitus Treatment Evaluation
The guideline update follows a growing body of clinical research evaluating Lenire’s safety and effectiveness. The device’s FDA authorization in 2023 was supported by evidence from the TENT-A3 clinical trial, alongside earlier research investigating bimodal neuromodulation for tinnitus. Additional real-world studies have examined outcomes among patients treated in clinical practice. One study published in Communications Medicine reported that 91.5% of patients experienced a clinically significant reduction in tinnitus symptoms, while a separate analysis published in the American Journal of Audiology reported clinically significant improvement in 81.8% of patients with bothersome tinnitus. These findings offer further evidence for evaluating the technology in appropriate clinical settings, although results from individual studies should not be interpreted as a guarantee of benefit for every patient. The updated AAO-HNSF guidelines are intended to support evidence-based decisions for adults with persistent, bothersome tinnitus, and clinicians must consider the overall evidence, patient preferences, treatment availability and individual needs when recommending care.
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Guideline Inclusion Expands Options for Hearing Care
The addition of Lenire highlights the evolving role of medical devices and neuromodulation technologies in hearing healthcare. For Neuromod Devices, the guideline inclusion represents a significant milestone in bringing its tinnitus treatment approach to greater attention among U.S. healthcare professionals. The company has stated that the technology is available through qualified providers in the United States and several international markets. Nevertheless, inclusion in a clinical practice guideline does not mean that the device is suitable for every patient or that it replaces other recommended management strategies. Tinnitus care may also involve education, hearing assessment, sound-based approaches and psychological interventions, depending on the patient’s circumstances. The updated guidance provides clinicians with a framework for making informed treatment decisions while identifying areas where further research is needed. Continued evaluation of clinical outcomes, patient experience and accessibility will help clarify the role of bimodal neuromodulation in long-term tinnitus management.
Source: Neuromod Devices press release
