Lenire Tinnitus Treatment Device Granted De Novo Approval by FDA

The U.S. Food and Drug Administration (FDA) has granted De Novo approval status to Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for treatment of tinnitus, according to Chicago-based Neuromod Devices Ltd, with world headquarters in Dublin, Ireland. The company reports treatment with Lenire to be available for Americans with tinnitus starting in April 2023.

Lenire is a combined acoustic and electrical intraoral stimulation device for the relief of tinnitus. It consists of three main parts: 1) a wireless consumer headphones which play custom sounds to the ear to activate the auditory nerve; 2) a Tonguetip^® that provides gentle electrical stimulation to the tongue surface, and 3) a controller that allows patients to adjust the duration and treatment intensity. Users are recommended to use the device for 60 minutes daily (e.g., two 30-minute sessions consecutively or at different times of the day).

The custom sounds and tongue stimulation work together to reduce patients' tinnitus severity. It is reportedly the first non-invasive bimodal neuromodulation tinnitus treatment device shown to relieve tinnitus in three large-scale clinical trials (see details below).

Lenire is already commercialized across Europe and available by audiologists or hearing technicians in numerous hearing centers for treating tinnitus. Neuromod has already been granted the CE mark in Europe for use by tinnitus sufferers 18 years of age and older in order to alleviate the symptoms of chronic, subjective tinnitus. Over the past 5 years, the company has completed two large-scale clinical trials evaluating the efficacy of its propriety technology in people with tinnitus.

In a press release announcing the de novo approval, Neuromod Devices Ltd highlighted:

• At least 25,000,000 Americans are suffering from tinnitus, 2,700,000 are veterans
• FDA approval is based on results of 112-patient pivotal TENT-A3 clinical trial supported by confirmatory Real-World Evidence from 204 patients
• TENT-A3 primary endpoint analysis showed that patients at least moderately impacted by tinnitus1 achieved a clinically meaningful improvement following the bimodal phase of the trial—consistent with what was observed in the Real-World Evidence submitted to the FDA
• Over the entire trial, 79.4% of patients experienced a clinically significant improvement: 82.4% were compliant to bimodal treatment and 88.6% would recommend Lenire as a tinnitus treatment
• When compared to sound therapy alone, patients at least moderately impacted by tinnitus¹ were significantly more likely to achieve a clinically meaningful improvement using Lenire's bimodal stimulation

"Lenire's approval not only means that millions of Americans living with tinnitus can get the treatment they need but further validates over a decade of research and development that resulted in a safe solution that provides relief for tinnitus patients,” said Neuromod Devices' Founding CEO Ross O'Neill in a press statement. “Lenire is the first bimodal neuromodulation device to go through the rigors of the FDA's De Novo process. For patients who are at least moderately impacted by their tinnitus,¹ Lenire has now been shown to be more effective than sound therapy, which is one of the current clinical standards of treatment.”

Tinnitus as a silent burden in healthcare

According to the press release from Neuromod, tinnitus—commonly known as “ringing in the ears”—is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans² are currently suffering from tinnitus.

Tinnitus is a silent burden on the U.S. healthcare system, costing an estimated $660 per patient per year for visits to clinics alone.³ Tinnitus is also the most prevalent and fastest-growing service-connected disability compensated for by The US Veterans Administration (VA), with more than 2.7 million veterans compensated in 2022⁴ and 12% year-on-year growth.⁵ It is estimated that the VA paid out more than $4.9 billion through its Veterans Compensation benefits program for tinnitus alone in 2022,⁶ with further undisclosed expenditure on treatments, such as hearing aids, sound therapy and counseling, which deliver varying levels of success.

Evidence for Lenire's approval and use for tinnitus treatment

According to Neuromod, the FDA's De Novo approval is based on the success of Lenire's third large-scale clinical trial, TENT-A3, supported by Real-World Evidence from 204 patients. Over the entire trial, 79.4% of the patients experienced a clinically significant improvement, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment.⁷

The TENT-A3 primary endpoint analysis showed that patients that were at least moderately bothered by tinnitus, which includes patients in the moderate, severe and catastrophic categories as defined by the Tinnitus Handicap Inventory (THI)¹, achieved a clinically meaningful improvement in tinnitus following the bimodal treatment phase of the trial. The analysis showed that this patient group was more likely to achieve a clinically meaningful improvement using Lenire's bimodal sound and tongue stimulation than sound therapy alone.⁷ TENT-A3 also demonstrated that Lenire is inherently safe with zero serious adverse events. These efficacy, compliance, and safety findings were highly consistent with the Real-World Evidence from 204 patients included in the De Novo submission.

TENT-A3 was a controlled clinical trial, designed by Neuromod to meet the FDA's requirements, that compared the effects of 6 weeks of bimodal neuromodulation with 6 weeks of sound therapy alone. The trial was conducted at 3 independent sites from March to October 2022 with 112 enrolled participants.⁸ The De Novo approval of Lenire is significant as it acknowledges Lenire as a technological and clinical pioneer for tinnitus treatment. This approval establishes a new regulatory category for medical devices in the USA.

“With this FDA approval of the Lenire device, it will provide me and tinnitus specialists across the United States with an exciting new tinnitus treatment option for our clinical toolbox,” says Jason Leyendecker, AuD, a leading tinnitus specialist and owner of The Tinnitus and Hyperacusis Clinic of Minnesota. Dr. Leyendecker is the past President of Minnesota Academy of Audiology and President-elect of Academy of Doctors of Audiology (ADA). “Many tinnitus patients are not availing of currently available options, such as hearing aids and counseling, 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 6 weeks of treatment, which can greatly improve our capacity issues since more patients can be helped in a shorter period of time.”

The TENT-A3 trial builds upon the success of two previous landmark clinical trials that included more than 500 patients. TENT-A1 was one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field. The study was the cover story for the journal Science–Translational Medicine in October 2020. TENT-A1 was a double-blind randomized trial involving 326 patients who were evaluated over a 12-week treatment period and a 12-month post-treatment phase.⁹ 86.2% of those who completed the 12 weeks of treatment reported improvement in their tinnitus severity. These therapeutic improvements continued for 12 months after cessation of treatment. 83.7% of patients were treatment compliant and there were zero serious adverse events in the trial.⁹

The results of Lenire's second large-scale clinical trial, TENT-A2, were published in the scientific journal Nature–Scientific Reports.¹⁰ The findings of this 192-patient double-blind randomized trial showed that changing stimuli midway through treatment enhanced the effectiveness of bimodal neuromodulation. 95% of patients that completed 12 weeks of treatment reported improvement in their tinnitus severity. These therapeutic effects were sustained up to 12 months after treatment ended.⁹ 83.8% of patients were treatment compliant and there were zero serious adverse events in the trial.¹⁰

“What is most remarkable is the consistency of the efficacy, safety and compliance data across our TENT-A1, TENT-A2 and TENT-A3 clinical trials,” said Prof. Hubert Lim, Chief Scientific Officer at Neuromod Devices. “Taken together, we have demonstrated the effectiveness and inherent safety of Lenire in over 600 clinical trial patients. De Novo approval from the FDA is another significant achievement in what has been an exciting journey for our bimodal stimulation technology.”

Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an Audiologist or ENT Surgeon, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.

"FDA approval of the Lenire Tinnitus Treatment System is a quantum leap forward in the caring of patients with bothersome tinnitus,” says Dr. Steven W. Cheung, who is a Professor of Otolaryngology-Head and Neck Surgery at the University of California, San Francisco, and Staff Otorhinolaryngologist at the Veterans Affairs San Francisco Healthcare System. “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."

Neuromod ramping up for U.S. training of Audiologists and ENTs

Neuromod Devices was founded by Dr. Ross O'Neill in 2010 to develop bimodal neuromodulation technologies for tinnitus and is supported by venture capital firms Fountain Healthcare Partners and Panakes Partners. In 2021, Neuromod established Neuromod USA Inc. as a wholly owned subsidiary to prepare for the market entry of Lenire in the USA pending FDA approval. Since then, Neuromod USA has convened a clinical advisory board of specialist tinnitus clinicians from across the US. These clinical experts will advise on and ensure that patients who will use Lenire receive unrivaled care throughout their treatment.

Following the FDA's granting of approval, Neuromod will train Audiologists and ENT Surgeons specializing in tinnitus care with the intention of treating the first tinnitus patients based in the USA as soon as April 2023.

More details about Lenire including a list of providers can be found at www.lenire.com.