A new paper evaluating Neuromod’s tinnitus treatment system has found that 91.5% of patients experienced clinically meaningful reductions in tinnitus after 12 weeks of treatment with the system.
The company’s Lenire system comprises Bluetooth headphones that deliver customised, paired sound stimuli to the auditory nerve; a handheld control for patients to adjust the length and intensity of treatment; and Tonguetip, an intra-oral device that provides gentle electrical stimulation to the tongue surface to activate nerves.
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The neuromodulation approaches are used simultaneously. Under the care of an audiologist with tinnitus expertise, patients typically use Lenire for two daily 30-minute sessions for an average of 12 weeks.
Co-authored by Emily McMahan, audiologist at the Alaska Hearing and Tinnitus Center (AHTC); and Professor Hubert Lim, professor of biomedical engineering and otolaryngology at the University of Minnesota and published in the journal Nature Communications Medicine, the authors analysed the results of 220 patients treated with Lenire at AHTC who had moderate or worse tinnitus.
Upon an interim check-up following six weeks of treatment, 78% of patients reported experiencing a clinically meaningful reduction in tinnitus. At 12 weeks, the figure rose to 91.5% of patients, besting the 89% of patients involved in a trial that supported Lenire being granted de novo classification by the US Food and Drug Administration (FDA) in 2023, who said they would recommend Lenire as a tinnitus treatment.
According to Neuromod, with the volume of patients analysed, the paper becomes one of the largest real-world analyses of tinnitus patients ever published in a peer-reviewed scientific journal.
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By GlobalDataCommonly described as a ‘ringing in the ears’, research indicates that around 25 million Americans and up to 740 million people globally are affected by tinnitus. With the highest incidence in those aged 65 and above, the condition can lead to complete deafness in some individuals.
McMahan commented: “Publication of this data in Nature Communications Medicine underscores how effective Lenire can be for tinnitus patients when they receive guidance from an experienced tinnitus care professional. I am confident we have entered an important new era of tinnitus care.”
Lenire is purported to be the only tinnitus treatment device of its kind approved by the FDA. Last year, Neuromod signed a Federal Supply Schedule 65 II Medical Equipment and Supply Contract with the US Government, making Lenire an option for veterans through the Department of Veterans Affairs.
