The American Academy of Otolaryngology, Head and Neck Surgery Foundation published an updated tinnitus clinical practice guideline on October 12, as a supplement to the October issue of Otolaryngology, Head and Neck Surgery. It carries new statements on bimodal neuromodulation, cochlear implantation, somatosensory tinnitus, self-harm and follow-up.
Neuromod Devices said October 16 that its Lenire device is named in the guideline, and calls it the first new treatment added since the document was established in 2014.
Lenire pairs sound with mild electrical stimulation of the tongue surface and holds a De Novo grant from March 2023, based on the TENT-A3 trial and real-world follow-up. The Dublin company sells it through prescribing clinicians in the US, Canada, Europe, Australia and the Veterans Affairs system.
Guideline inclusion matters more for payment than for marketing. A named mention in a specialty society document is what coverage reviewers and hospital technology committees read when a device has no established code or benefit category. For a De Novo holder that wrote its own regulation, clearing that step is usually the slower half of the work.