Neuromod Devices has announced that the US Food and Drug Administration (FDA) has granted de novo approval to Lenire—the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus, according to a company press release.
“FDA approval of the Lenire tinnitus treatment system is a quantum leap forward in the caring of patients with bothersome tinnitus,” said Steven Cheung (University of California San Francisco [UCSF], San Francisco, USA). “The otolaryngologist now has access to innovative Lenire technology and can prescribe it to patients who are at least moderately impacted by their tinnitus. The majority of these tinnitus patients are either inadequately relieved or are opting not to pursue existing options, such as hearing aids. These patients can now move forward with this impressive treatment system.”
The FDA’s de novo approval of Lenire is “significant”, Neuromod states in a press release, as it acknowledges the device as a technological and clinical pioneer for tinnitus treatment, and also establishes a new regulatory category for medical devices in the USA.
The release details that this approval was based on the success of Lenire’s third large-scale clinical trial, TENT-A3, which compared the effects of six weeks of bimodal neuromodulation versus six weeks of sound therapy alone in 112 enrolled participants. Over the entire trial, 79.4% of patients experienced a clinically significant improvement with Lenire, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment, Neuromod states. TENT-A3 also demonstrated that Lenire is “inherently safe”, with zero serious adverse events being observed.
According to Neuromod, these efficacy, compliance and safety findings were “highly consistent” with real-world evidence from 204 patients included in the recent de novo submission to the FDA. The TENT-A3 trial further built on two prior randomised, double-blind clinical trials including more than 500 patients in total; TENT-A1, which the company claims is one of the largest and longest followed-up trials ever conducted in the tinnitus field, and TENT-A2. Both trials demonstrated sustained therapeutic benefits with Lenire, according to Neuromod, and have been published in the journals Science: Translational Medicine and Nature: Scientific Reports, respectively.
“With this FDA approval of the Lenire device, it will provide me and tinnitus specialists across the USA with an exciting new tinnitus treatment option for our clinical toolbox,” said Jason Leyendecker (The Tinnitus and Hyperacusis Clinic of Minnesota, Edina, USA). “Many tinnitus patients are not availing of currently available options, such as hearing aids and counselling, and success with these options is varied. What is especially encouraging about this new bimodal treatment is that it can deliver clinical benefits in as short as six weeks of treatment, which can greatly improve our capacity issues, since more patients can be helped in a shorter period of time.”
Following the FDA’s granting of approval, Neuromod will train audiologists and ear, nose and throat (ENT) surgeons specialising in tinnitus care, with the intention of treating the first USA-based tinnitus patients as soon as April 2023.