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CHICAGO, March 7, 2023 /PRNewswire/ — Neuromod Devices Ltd. today announced that the US Food and Drug Administration (FDA) has granted De Novo approval for Lenire, the first bimodal neuromodulation device from this type approved by the FDA for the treatment of tinnitus.

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 suffer from tinnitus today.

Tinnitus is a silent burden to the US national healthcare system, costing an estimated $660 per patient per year for clinic visits alone3. Tinnitus is also the most prevalent and fastest-growing service-connected disability compensated by the US Veterans Administration (VA), with more than 2.7 million compensated veterans in 20224 and 12 year-over-year growth %5. The VA is estimated to have paid more than $4.9 billion for tinnitus alone through its VA compensation program in 20226, with other undisclosed spending on treatments such as hearing aids, sound therapy, and counseling, which offer varying levels of of success.

“Lenire’s approval not only means millions of Americans suffering from tinnitus can get the treatment they need, it also validates more than a decade of research and development that has resulted in a safe solution that provides relief for tinnitus patients.” Lenire is the first bimodal neuromodulation device to have passed the rigors of the FDA De Novo process Lenire has been shown to be more effective than sound therapy, which is one of the current clinical standards of treatment, for patients who experience at least moderate impact from tinnitus1,” said Ross O’Neill, Founding CEO of Neuromod Devices.

The FDA’s De Novo approval builds on the success of Lenire’s third large-scale clinical trial, TENT-A3, supported by actual evidence from 204 patients. Throughout the trial, 79.4% of patients experienced clinically significant improvement, 82.4% were compliant with bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment7. Analysis of the primary endpoint of TENT-A3 showed that patients experiencing at least moderate tinnitus discomfort, including patients in the moderate, severe, and catastrophic categories as defined by the Tinnitus Handicap Inventory (THI)1 , achieved a clinically significant improvement in tinnitus after the bimodal treatment phase of the trial. Analysis demonstrated that this group of patients was more likely to achieve clinically significant improvement using Lenire’s bimodal stimulation with sound and tongue than sound therapy alone7. TENT-A3 also demonstrated that Lenire is intrinsically safe, with zero serious adverse events7. These efficacy, compliance and safety results were highly consistent with actual evidence from 204 patients included in the De Novo presentation.

TENT-A3 was a controlled clinical trial, designed by Neuromod to meet FDA requirements, comparing the effects of 6 weeks of bimodal neuromodulation with 6 weeks of sound therapy alone. The trial was conducted at three independent centers from March to October 2022 with 112 enrolled participants8. Lenire’s De Novo approval is significant as it recognizes Lenire as a technological and clinical pioneer for the treatment of tinnitus. This approval establishes a new regulatory category for medical devices in the US.

“With this FDA approval, the Lenire device will provide me and tinnitus specialists across the United States with an exciting new tinnitus treatment option for our clinical toolbox,” explained Jason Leyendecker, MD (AuD). . “Many tinnitus patients do not take advantage of currently available options such as hearing aids and counselling, and success with these options is mixed. What is especially encouraging about this new bimodal treatment is that it can provide clinical benefits in as little as 6 weeks of treatment, which can greatly improve our capacity issues as more patients can be helped in a shorter period of time.” Dr. Leyendecker is a leading Tinnitus specialist and owner of The Tinnitus and Hyperacusis Clinic of Minnesota. He was president of the Minnesota Academy of Audiology and president-elect of the Academy of Audiology Doctors.

The TENT-A3 trial builds on the success of two previous landmark clinical trials involving more than 500 patients. TENT-A1 was one of the largest and longest-followed clinical trials ever conducted in the field of tinnitus. The study was on the cover of the prestigious scientific journal Science – Translational Medicine in October 2020. TENT-A1 was a double-blind randomized trial involving 326 patients who were evaluated during a 12-week treatment period and a post-treatment phase of 12 months9. 86.2% of those who completed 12 weeks of treatment reported an improvement in the severity of their tinnitus9. These therapeutic improvements continued for 12 months after cessation of treatment. 83.7% of the patients complied with the treatment and there were no serious adverse effects in the trial9.

The results of Lenire’s second large-scale clinical trial, TENT-A2, have been published in the prestigious scientific journal Nature – Scientific Reports. The results of this randomized, double-blind trial with 192 patients demonstrated that mid-treatment stimulus switching increased the efficacy of bimodal neuromodulation. 95% of patients who completed 12 weeks of treatment reported an improvement in tinnitus severity10. These therapeutic effects were maintained up to 12 months after the end of treatment9. 83.8% of the patients complied with the treatment and there were no serious adverse effects in the trial10.

“Most remarkable is the consistency of efficacy, safety and compliance data across our TENT-A1, TENT-A2 and TENT-A3 clinical trials. Collectively, we have demonstrated the inherent efficacy and safety of Lenire in more than 600 patients. of clinical trials. The FDA’s De Novo approval is another significant achievement in what has been an exciting journey for our bimodal stimulation technology,” said Prof. Hubert Lim, Chief Scientific Officer of Neuromod Devices.

Tinnitus patients are prescribed Lenire by an appropriately qualified healthcare professional, such as an audiologist or otolaryngologist, after a suitability assessment, and can complete treatment at home between follow-up appointments with their doctor.

“The FDA approval of the Lenire system for the treatment of tinnitus marks a major step forward in the care of patients with bothersome tinnitus. The otolaryngologist now has access to the innovative Lenire technology and can prescribe it to patients suffering from at least one impact of their tinnitus. Most of these tinnitus patients do not feel enough relief or choose not to pursue existing options such as hearing aids. These patients can now move forward with this impressive treatment system,” said Dr. Steven W. Cheung, professor of otolaryngology and head and neck surgery at the University of California, San Francisco and a staff otolaryngologist with the Veterans Affairs San Francisco Healthcare System.

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 incorporated Neuromod USA Inc. as a 100% subsidiary to prepare Lenire for market entry in the United States, pending FDA approval. Since then, Neuromod USA has convened a clinical advisory board of tinnitus physicians from across the United States. These clinical experts will advise and ensure that patients using the Lenire receive unrivaled care throughout their treatment.

Following FDA approval, Neuromod will train tinnitus audiologists and ENT specialists with the intent to treat the first tinnitus patients in the US in April 2023.

References and notes

1. Measured using the Tinnitus Handicap Inventory (THI). The THI is the most widely used clinical standard for measuring the impact of tinnitus on a person’s daily life. The THI is a validated instrument that is measured on a scale of 100; the higher the score, the greater the impact of tinnitus. THI scores are classified into five severity levels: mild, light, moderate, severe, and catastrophic. Patients who are at least moderately affected by tinnitus have a THI score of 38 or greater and fall into the moderate, severe, and catastrophic categories.2. https://www.nidcd.nih.gov/health/tinnitu…3. Goldstein E., Ho C.X., Hanna R., Elinger C., Yaremchuk K.L., Seidman M.D., Jesse M.T. Cost of care for subjective tinnitus in relation to patient satisfaction. Otolaryngol. Head Neck Surg. 2015;152:518–523. doi: 10.1177/0194599814566179.4. FY 2022 US VA Benefits Report: https://www.benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf 5. Calculation based on average annual increase of tinnitus benefit recipients from 2008 to 2022: https://www.benefits.va.gov/REPORTS/abr/… 6. According to https://www.va.gov/disability/compensation-rates/veteran -rates/past-rates-2022/ The 10% disability rate in 2022 was $152.64 per month. 2,703,665 veterans ( https://www.benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf) receiving 12 payments of $152.64 for tinnitus equals $4.952 million. VA assigns a 10% disability rating to tinnitus: https://www.benefits.com/veterans-disability/tinnitus-most-common-va-disability 7. Data from the TENT-A3 clinical trial in preparation for publication 8 https://clinicaltrials.gov/ct2/show/NCT0…9. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)10. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)

For more information Joe RocheHead of CommunicationsNeuromod Devicesjoe.roche@neuromoddevices.com 353 87 416 0138

About Neuromod Devices Ltd

Founded in 2010, Neuromod Devices Ltd. is a medical technology company based in Dublin, Ireland. Neuromod specializes in the design and development of bimodal neuromodulation technologies to address the clinical needs of patients suffering from chronic and debilitating tinnitus. Neuromod’s Lenire device for the treatment of tinnitus is currently available throughout Europe and has received De Novo FDA approval in the United States. For more information, visit www.neuromoddevices.com.

About Lenire

Lenire is a combined intraoral acoustic and electrical stimulation device for the relief of tinnitus. The device’s novel bimodal neuromodulation technology consists of three parts. A Bluetooth® headset, which plays personalized sounds into the ear to activate the auditory nerve, a Tonguetip®, a patented intraoral device that also activates nerves by sending mild electrical stimulation to the surface of the tongue, and a controller that allows patients adjust the duration and intensity of treatment.

Personalized sounds and tongue stimulation work together to reduce the severity of patients’ tinnitus. It is the first non-invasive bimodal neuromodulation device for the treatment of tinnitus to be shown to alleviate tinnitus in three large-scale clinical trials.

Lenire has obtained FDA De Novo approval for the treatment of tinnitus in the US and CE Mark certification in Europe. For more information about Lenire, including a list of providers, visit www.lenire.com.

Connect with Neuromod Devices Ltd

LinkedIn: linkedin.com/company/neuromod Twitter: twitter.com/NeuromodDevices Sitio web: neuromoddevices.com

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