The American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) has included Lenire (bimodal neuromodulation) as a treatment option in the academy’s new Clinical Practice Guidelines for Tinnitus.
Bimodal neuromodulation is the only new treatment recommendation added to the AAO-HNSF guidelines since their establishment in 2014. Building on the FDA’s landmark approval of Lenire in 2023 (the first and only bimodal neuromodulation device approved by the FDA), further establishes Lenire as a new standard of care for tinnitus in the USA.
The AAO-HNSF guidelines help ENTs across the United States to clinically evaluate and manage tinnitus in everyday care. The guidelines “emphasise interventions and therapies deemed beneficial” and directs American ENTs “to avoid treatments that are time-consuming, costly, inaccessible and ineffective”.
US ENTs can now confidently recommend Lenire knowing that it has been reviewed by the academy’s panel of tinnitus experts.
Lenire combines sound stimulation with mild electrical stimulation to the surface of the tongue (bimodal neuromodulation) to relieve the symptoms of tinnitus. Lenire has been proven effective and inherently safe in three large-scale clinical trials and validated in a growing body of real-world clinical outcomes.
Lenire’s landmark FDA approval in March 2023 was based on the pivotal TENT-A3 controlled clinical trial and confirmatory real-world evidence. The results were published in Nature Communications.
Results in the first peer-reviewed real-world paper published in Nature Communications Medicine reported 91.5% of tinnitus patients had a clinically significant reduction in tinnitus.
The second real-world retrospective analysis published in The American Journal of Audiology reported that 81.8% of patients with bothersome tinnitus reported a clinically significant reduction in tinnitus.
