The groundbreaking tinnitus treatment device, Lenire, has garnered significant attention following the publication of its pivotal clinical trial results in Nature Communications. This development marks a major milestone for Neuromod Devices, the creators of Lenire, as the device becomes the first and only bimodal neuromodulation therapy for tinnitus to receive approval from the US Food and Drug Administration (FDA).
Tinnitus, commonly referred to as ‘ringing in the ears,’ is a complex neurological condition characterised by the perception of sound without an external source. Affecting an estimated 25 million Americans, it remains the most prevalent service-connected disability compensated by the US Veterans Administration, with over 2.9 million veterans receiving compensation for the condition in 2023.
Lenire’s journey to FDA approval was anchored by the success of the TENT-A3 clinical trial (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3), which was crucial to the device’s De Novo FDA submission. The trial, conducted between March and October 2022 across three independent sites, involved 112 participants with moderate or severe tinnitus. The study compared Lenire’s innovative bimodal neuromodulation treatment, which combines sound therapy with mild electrical stimulation of the tongue, to sound therapy alone.
The trial was meticulously designed and executed with guidance from the FDA, ensuring the robustness of the findings. Participants initially underwent six weeks of sound-only stimulation as a control condition. This was followed by six weeks of treatment using Lenire’s bimodal neuromodulation, where tongue stimulation was added to the auditory component. The results were compelling: 70.5% of participants who had not experienced meaningful improvement from sound-only therapy reported clinically significant relief from tinnitus after using Lenire.
Moreover, the majority of participants who received six weeks of sound-only therapy reported additional benefits after undergoing the combined bimodal treatment. The trial also demonstrated that Lenire is not only more effective than sound therapy alone but also inherently safe, with no device-related serious adverse events recorded.
Dr. Ross O’Neill, Founding CEO of Neuromod, highlighted the significance of these findings. “Tinnitus has long been an unmet need in hearing healthcare,” he said. “Patients have often been left disappointed by treatments lacking strong clinical evidence or regulatory approval. Lenire, with its success in the TENT-A3 trial and subsequent De Novo FDA approval, stands out as the only tinnitus treatment supported by multiple large-scale clinical trials and endorsed by the FDA.”
Lenire’s bimodal neuromodulation approach involves delivering mild electrical pulses to the tongue via an intra-oral component known as the Tonguetip®, while simultaneously providing auditory stimulation through headphones. This method has shown not only to provide significant relief from tinnitus but also to sustain these effects for at least 12 months post-treatment, according to large-scale clinical trials.
The publication of the TENT-A3 trial results in Nature Communications is a significant achievement for Neuromod Devices, further cementing Lenire’s status as a category-defining intervention for tinnitus. The paper, titled Combining Sound with Tongue Stimulation for the Treatment of Tinnitus: A Multi-site Single arm Controlled Pivotal Trial, offers detailed insights into the trial’s methodology and outcomes, reinforcing the scientific rigour behind Lenire’s development.
Clinical experts have also voiced their support for Lenire. Professor Gail Whitelaw, Clinic Director at The Ohio State University’s Department of Speech and Hearing Science, noted the impact of Lenire’s FDA approval on her practice. “The rigorous design of Lenire’s controlled clinical trial, coupled with its FDA approval, were compelling factors in my decision to offer this treatment. It has become a landmark addition to my tinnitus treatment options, and my patients have benefitted greatly from the overwhelmingly positive results,” she said.
Compliance with Lenire’s treatment protocol has been high, with 82.4% of participants adhering to the bimodal therapy. Additionally, 88.6% of participants stated that they would recommend Lenire to others seeking relief from tinnitus.
As Neuromod Devices continues to advance the field of tinnitus treatment, Lenire’s approval represents a significant breakthrough, offering new hope to millions affected by this debilitating condition. With its proven efficacy, safety, and positive patient feedback, Lenire is poised to redefine the landscape of tinnitus management.