Author: Joe Roche

Nearly half of all Canadian adults have experienced tinnitus in their lifetime and a new at-home tinnitus treatment device offers chronic sufferers hope.

• Lenire tinnitus treatment device now available in Canada through 21 clinics across Alberta, British Colombia, Manitoba, Ontario, and Québec.
• 43% of Canadians (11.2m) report experiencing tinnitus in their lifetime with 37% of Canadians (9.2m) report experiencing tinnitus in the past year according to data from a Canadian Health Measures Survey (CHMS).¹
• 84% of 517 tinnitus patients across two large-scale clinical trials reported relief from tinnitus that sustained for at least 12-months.^2,3
• 91.5% of tinnitus patients reported significant relief from tinnitus in a peer-reviewed analysis of patients treated with Lenire at an independent clinic.⁴

“Lenire has been a miracle that has changed my life” – Toronto-based tinnitus patient, Jim Gray.

Toronto, Canada – Tuesday, April 7, 2026: Neuromod Devices, the medical technology company that specialises in tinnitus treatment technology, has made the Lenire tinnitus treatment device available in Canada.

Lenire will be exclusively available through hearing care clinics with expertise in tinnitus in Ontario, British Columbia, Alberta, Manitoba, and Québec. Lenire will be available in 21 clinics as part of the device’s initial Canadian launch. Neuromod has planned further expansion in 2026.

Lenire^® is the first bimodal neuromodulation device that has been proven to provide long-term relief from tinnitus. This has been proven across multiple large-scale clinical trials. ^2,3 The device combines mild pulses to the surface of the tongue via the ‘Tonguetip^®’, with auditory stimulation. This dual stimulus drives changes to the brain and can deliver long-term relief from tinnitus.

Tinnitus is commonly known as ringing, hissing, or buzzing in the ears. 43% of Canadians report experiencing tinnitus in their lifetime. 37% report experiencing tinnitus in the past year according to a Canadian Health Measures Survey.¹

“In the last few years, thousands of Canadians living with tinnitus have made contact with Neuromod to ask our team to make Lenire available in Canada. Today, I’m proud to say we have delivered for these people, the millions of others living with tinnitus, and for their healthcare providers,” said Neuromod Founder and CEO, Dr. Ross O’Neill. “A high prevalence of tinnitus in Canada is driving demand for clinically proven treatment options. Neuromod is excited to partner with leading tinnitus care clinics to make Lenire available to the millions of people living with constant noise in Canada.”

Lenire’s availability in Canada follows a comprehensive audit that verified Neuromod’s compliance with the international standard ISO13485 and regulatory requirements in multiple regulatory jurisdictions including Canada (Health Canada).  

Clinical Trials Demonstrate Lenire Sustained Tinnitus Relief

Canada is the latest country to make Lenire^® available in 2026, following successful launches in The Netherlands, Portugal, and further expansion in the USA.

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device that has been proven effective in clinical trials and in real world patient analyses.

In 2023, the United States Food and Drug Administration (US FDA) granted De Novo approval to Lenire, making it the first and only bimodal neuromodulation device to achieve this milestone.

De Novo Approval from the FDA was granted based on the success of Lenire’s TENT-A3 controlled clinical trial. TENT-A3 demonstrated that Lenire was clinically superior for the treatment of tinnitus than sound-therapy. Sound-therapy was the trial’s control. ⁵ The Medical Device Single Audit Program (MDSAP) approved Lenire following the device’s FDA Approval. Lenire secured authorisation from Health Canada in late 2025.

Since then, Neuromod has been training hearing care professionals with tinnitus expertise throughout Canada to provide treatment with Lenire.

Nature – Scientific Reports published results from Lenire’s second large-scale clinical trial, TENT-A2. TENT-A2 showed 95% of compliant patients reported tinnitus improvement. 91% reported long-term relief that sustained for at least a year after treatment ended.¹

“Hearing Solutions has been treating tinnitus patients for more than 25 years, and we are seeing more patients presenting to our clinicians with tinnitus as their primary concern, reflecting increased awareness and demand for care,” said Ron Abish, Founder, President and CEO of Hearing Solutions. “We are excited to expand the treatment options for our tinnitus patients with Lenire, a device that has demonstrated strong clinical trial results and real-world effectiveness.”

Watch: Toronto-based tinnitus patient share how Lenire gave him relief from tinnitus.

Lenire Proven Effective with Tinnitus Patients Treated at Independent Clinics

Results from Lenire’s real world patient analyses are consistent with the bimodal neuromodulation device’s clinical trial patient outcomes.

Nature Communications Medicine peer-reviewed and published the results of real world patients with bothersome tinnitus. The independent clinic, Alaska Hearing & Tinnitus, treated these patients with Lenire. 91.5% of 220 patients reported clinically meaningful reductions in tinnitus after treatment with Lenire.²

The American Journal of Audiology published results of 140 real world patients with bothersome tinnitus. The independent clinic, New York Hearing Doctors, treated these patients with Lenire. 81.8% of 140 patients reported clinically meaningful relief from tinnitus after treatment with Lenire.

“Due to my tinnitus, I had to take medication to get to sleep, which I hated to do and I was worried that it was going to get even worse.” said Toronto-based tinnitus patient, Jim Gray. “Lenire showed me that you can solve problems like tinnitus, it has been a miracle that has changed my life, “

Leading tinnitus charity, Tinnitus UK, rated Lenire as the top treatment option for safety and effectiveness. This rating acknowledges the large and ever-expanding evidence base for Lenire.

Lednire is available in Canada exclusively through hearing care clinics. These clinics are comprehensively trained to administer tinnitus care with Lenire following a suitability assessment. Patients can find a clinic providing Lenire in Canada by visiting www.lenire.com/find-a-clinic/.

About Neuromod Devices

Neuromod Devices is a global medical technology company with offices in Ireland and North America. The company specialises in the design and development of neuromodulation technologies to address the clinical needs of tinnitus patients.

Neuromod has completed extensive clinical trials. These trials aimed to confirm the safety and effectiveness of its non-invasive bimodal neuromodulation tinnitus treatment device, Lenire.

For more information about Neuromod visit www.neuromod.com.

References

1. Ramage-Morin, P.L, Banks, R., Pineault, D., Atrach, M., Health Reports: Tinnitus in Canada, https://www.doi.org/10.25318/82-003-x201900300001-eng (2019)
2. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, nature.com/articles/s41598-022-13875-x (2022)
3. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
4. Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment, Commun Med (2025)
5. Boedts, M., Beuchner, A., Khoo, S.G. et al Combining sound with tongue stimulation for the treatment of tinnitus. A multi-site single-arm controlled pivotal trial. Nature Comms. (2024) 

Lenire Tinnitus Treatment Device Now Available in The Netherlands

• Lenire tinnitus treatment device is now available in HearConsult Utrecht and Mijdrecht.
• 91% of compliant patients reported long lasting relief from tinnitus that sustained for at least 1-year in a large-scale clinical trial.¹
• 91.5% of tinnitus patients reported significant relief from tinnitus in a peer-reviewed analysis of patients treated with Lenire at an independent clinic.²
• Tinnitus affects over 2 million adults in The Netherlands³ with reports suggesting incidences of tinnitus have increased by 33% between 2012 and 2021.⁴
• Expanding Lenire’s availability to The Netherlands is part of Neuromod’s ongoing strategy to expand Lenire’s footprint across Europe.

Tinnitus is on the rise in The Netherlands – but a new proven treatment method now available in The Netherlands offers hope.

Neuromod has partnered with HearConsult to make the Lenire tinnitus treatment device available in The Netherlands.

Lenire^® is a groundbreaking bimodal neuromodulation device that has been proven to provide clinically significant relief from tinnitus across multiple clinical trials and with real world patients.^1,2,5

Tinnitus, commonly known as ringing in the ears, affects over 2 million adults in the Netherlands. A recently published paper reported that tinnitus incidence in the Netherlands increased by 33% from 2012 to 2021. The authors attributed this rise to increased exposure to loud music, noise pollution, and evolving listening habits. They also found that the largest increase occurred among younger adults aged 20–44 years.

Expanding Lenire’s availability to The Netherlands is part of Neuromod’s ongoing strategy to expand Lenire’s footprint across Europe.

Jan van Dam, a Utrecht-based researcher tells his story of using Lenire to relieve his tinnitus.

Lenire Now Available in The Netherlands, Across Europe and the USA

The Netherlands is the latest country to make Lenire^® available. The company launched the device in Denmark, Norway, Spain, Italy, Poland, Sweden, and Switzerland, and later expanded into the United Kingdom.

“There has been a significant increase of people whose primary concern is tinnitus in our clinic and this is common across all Dutch audiology practices,” said Koen Vernooij Au.D., owner of HearConsult. “We have seen the remarkable evidence from clinics across Europe and the United States and we are excited to make this proven treatment option available at our clinic.”

Utrecht-based researcher, Jan van Dam, spoke about his experience living with tinnitus for decades. Jan traveled to Belgium to receive treatment with Lenire before the device became available in the Netherlands.

“As a researcher, I spend quite a lot of time focusing in quiet spaces, and the noise from my tinnitus was very distracting, and it also made socialising difficult,” said Jan van Dam. “I found Lenire’s clinical research compelling and now, after treating my tinnitus with the device, the tinnitus is much quieter, and it no longer annoys me.”

Lenire Proven to Provide Long-term Relief from Tinnitus

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device. Clinical trials and real-world patient analyses have proven the device effective. Lenire combines tongue and auditory stimulation through bimodal neuromodulation. This approach drives long-term changes in the brain and relieves tinnitus severity.

In 2023, Lenire made regulatory history by becoming the first and only bimodal neuromodulation device to be granted De Novo approval by the United States of America Food and Drug Administration (US FDA).

De Novo Approval from the FDA was granted based on the success of Lenire’s TENT-A3 controlled clinical trial. TENT-A3 demonstrated that Lenire was clinically superior for the treatment of tinnitus than sound-therapy, which was the trial’s control.⁵

Nature – Scientific Reports published results from Lenire’s second large-scale clinical trial, TENT-A2. TENT-A2 showed 95% of compliant patients reported tinnitus improvement. 91% reported long-term relief that sustained for at least a year after treatment ended.¹

Nature Communications Medicine recently published the results of 220 tinnitus patients treated with Lenire in a real-world clinical setting. 91.5% of patients reported clinically meaningful reductions in tinnitus after treatment with Lenire.²

Tinnitus UK has rated Lenire as the top tinnitus treatment option for safety and effectiveness, acknowledging the evidence base.

Lenire is available in The Netherlands through HearConsult following a suitability assessment.

Tinnitus and Lenire Information Sessions in Mijdrecht

HearConsult is running 4 information sessions for patients with tinnitus on the 26^th and 27^th of March in Mijdrecht. There will be 2 sessions per day at 14:00 and 20:00. The sessions will cover the causes of tinnitus and the available treatment options. As well this, the session will feature tips for managing your tinnitus.

Attendance is free but places are limited and must be reserved in advance at https://www.hearconsult.nl/ Complimentary parking and refreshments provided.

About Neuromod Devices

Neuromod Devices is a global medical technology company with offices in Ireland and the USA. The company specialises in the design and development of neuromodulation technologies to address the clinical needs of tinnitus patients.

Neuromod has completed extensive clinical trials to confirm the safety and effectiveness of Lenire.

For more information about Neuromod visit www.neuromod.com.

Now Available in The Netherlands – About Lenire

Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials.

Bimodal neuromodulation stimulates nerves with two paired stimuli for therapeutic purposes. Lenire, the tinnitus treatment device used in the study, was developed by Neuromod Devices. The device uses wireless (Bluetooth®) headphones to deliver sequences of audio tones to both ears and delivers electrical stimulation pulses to the surface of the tongue through 32 electrodes on a proprietary device trademarked as Tonguetip. Clinicians can configure the device’s settings to provide treatment with different combinations of audio and electrical stimuli.

The easy-to-use handheld controller controls the timing, intensity, and delivery of the stimuli. Clinicians train each participant to use the controller before the participant continues treatment from home. An appropriately qualified healthcare professional, such as an audiologist or ENT surgeon, prescribes Lenire to patients with tinnitus after assessing their suitability. Patients then complete treatment from home between follow-up appointments with their clinician.

About HearConsult

HearConsult is a specialty tinnitus care clinic with locations in Mijdrecht and Utrecht. Founded by Koen Vernooij, AuD, a practitioner with over 30 years of experience in the hearing care sector, HearConsult focuses on personalised care, honesty, and education for tinnitus patients.

References

1. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, nature.com/articles/s41598-022-13875-x (2022)
2. Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment, Commun Med (2025)
3. R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021)
4. Bes, J. et al, The impact of tinnitus on Dutch GPs: A retrospective study using routine healthcare data, https://doi.org/10.1371/journal.pone.0313630 (2024)
5. Boedts, M., Beuchner, A., Khoo, S.G. et al Combining sound with tongue stimulation for the treatment of tinnitus. A multi-site single-arm controlled pivotal trial. Nature Comms. (2024)

• 81.8% of patients with bothersome tinnitus treated with Lenire at New York Hearing Doctors reported significant improvement in a real-world clinical setting in Lenire real patient analysis.^1,2  

• Patients with bothersome tinnitus reported a 23.8 point mean reduction in tinnitus as measured by the Tinnitus Handicap Inventory, which is greater than three times the threshold for clinical significance.^1,2 

• The majority of patients with bothersome tinnitus reported they were no longer severely impacted by their tinnitus following 12-weeks of Lenire.^1,2  

• This evidence is consistent with the first real world analysis of U.S. tinnitus patients treated with Lenire that was peer-reviewed and published in Nature Communications Medicine.³ 

New York, February 17, 2025: The American Journal of Audiology has peer-reviewed and published the positive outcomes of U.S. tinnitus patients treated with Lenire, the only FDA approved tinnitus treatment device of its kind. 

Results in the paper titled: “Bimodal Neuromodulation for Tinnitus in a Clinical Practice Setting: Clinically Significant Benefit for Patients with Moderate or Worse Symptoms” reported 81.8% of patients with bothersome tinnitus had a clinically significant reduction in tinnitus when treated with Lenire.^1,2  

• Read the paper: https://pubs.asha.org/doi/10.1044/2025_AJA-25-00090

Largest Body of Real World Evidence for a Bimodal Tinnitus Treatment Device

These Lenire real patient anlaysis results are consistent with previously published Lenire treatment outcomes. This shows repeatable success for tinnitus patients in real world clinical settings. 

In addition to being supported by the largest body of clinical trial data in its field, Lenire is now underpinned by the most extensive real-world evidence of safety and effectiveness, following publication of this research in The American Journal of Audiology. 

The paper, authored by Dr. Craig Kasper Au.D of New York Hearing Doctors (NYHD) et al, analyzed the results of 140 tinnitus patients who were fitted with Lenire at NYHD between May 1, 2023, and January 19, 2024. 

Tinnitus is commonly known as ringing in the ears but can manifest as hissing, buzzing, and other persistent sounds. The condition afflicts an estimated 25 million American adults⁴, with an estimated 2.5 million tinnitus patients living in New York alone.⁵ 

American Journal of Audiology Publishes Lenire Real Patient Analysis

Lenire uses bimodal neuromodulation to treat tinnitus. Bimodal neuromodulation is the simultaneous stimulation of two nerves for therapeutic purposes. Lenire plays audio tones via headphones while delivering mild energy pulses to the surface of the tongue to treat tinnitus. Under the care of an audiologist with tinnitus expertise, patients with bothersome tinnitus typically use the device at home for two 30-minute sessions daily for approximately 12 weeks. 

This paper is the second in a series of planned, real-world evidence publications that have been compiled from thousands of U.S. tinnitus patients that have been successfully treated with Lenire.    

The analysis found that at the interim check-up, after six weeks of treatment with Lenire, 72.6 percent of patients with bothersome tinnitus had a clinically meaningful reduction in tinnitus.^1,2 After 12-weeks, 81.8% of patients with bothersome tinnitus had a clinically meaningful reduction.^1,2 

Patients reported a mean reduction of 23.8 points on the Tinnitus Handicap Inventory (THI) after 12-weeks, greater than three times the threshold for clinically significant reduction.^1,2 As a result, the majority of patients with bothersome tinnitus reported they were no longer severely impacted by their tinnitus following 12-weeks of Lenire, according to tinnitus severity grading guidelines.^{1, 2, 11} 

Lenire is“Nothing Less Than a Game-Changer”

“New York Hearing Doctors stay on the cutting-edge of tinnitus care through the introduction of modern technologies like Lenire and leveraging research to consistently refine our treatment methodologies,” said NYHD founder, Dr. Craig Kasper, Au. D. “The combination of our personalized approach to tinnitus care and the remarkable effectiveness of Lenire, we are seeing life-changing treatment outcomes for our patients.” 

“Lenire was nothing less than a game-changer in my life. I went from debilitating, almost catastrophic tinnitus, that required medication to treat the depression and anxiety, to being able to enjoy life again after four months of Lenire.” said Richard Bistrong, tinnitus patient at New York Hearing Doctors, “Three years later, I can enjoy my life and not worry about my tinnitus. This has impacted not only my well-being but my loved ones as well. For anyone that is looking for relief, that is based in science and patient results, I would encourage you to seek your local Lenire Provider as soon as possible to learn more about Lenire.” 

Data Summary from Lenire’s 1st Published RWE Paper.

Lenire Real Patient Analysis Consistent with 1st Peer-Reviewed and Published Paper

The evidence in this paper is consistent with the first peer-reviewed real-world analysis of U.S. tinnitus patients treated with Lenire. It is also consistent with results from Lenire’s large-scale clinical trials.^3,6,7,8 

The first real world analysis of U.S. patients treated with Lenire was peer-reviewed and published in Nature Communications Medicine. It showed that 91.5% of Lenire patients had a clinically significant reduction in tinnitus after 12-weeks. This consistency demonstrates the effectiveness of a typical treatment protocol with Lenire in a real-world clinical setting. 

Lenire’s controlled TENT-A3 clinical trial facilitated FDA approval in March 2023, and Nature Communications published the results. The paper remains in the 99th percentile of more than 250,000 tracked Nature articles. 

TENT-A3 included 112 trial participants. The trial demonstrated Lenire’s clinical superiority to sound-only therapy, a widely used treatment for tinnitus. Nearly 89% of trial participants said they would recommend Lenire as a tinnitus treatment.⁶ 

According to Neuromod Devices founder and CEO, Dr. Ross O’Neill, Lenire’s principal inventor: “The consistency of the real-world outcomes of US tinnitus patients treated with Lenire with our large-scale clinical trials demonstrates the replicability and scalability of Lenire as a tinnitus treatment option for the over 740 million people worldwide living with tinnitus.”  

“By working closely with our network of providers, we are seeing market-surpassing patient outcomes, improving clinical best practices, and a rapidly growing body of robust real-world evidence positioning Lenire and bimodal neuromodulation as a leading tinnitus treatment option.” 

Lenire is available through specialized tinnitus clinics in the United States of America and Europe. Lenire is also a treatment option through the US Department of Veterans Affairs. 

References and Notes 

1. Kasper, C et al. Bimodal Neuromodulation for Tinnitus in a Clinical Practice Setting: Clinically Significant Benefit for Patients with Moderate or Worse Symptoms, American Journal of Audiology, https://doi.org/10.1044/2025_AJA-25-00090 (2025) 

2. As measured by Tinnitus Handicap Inventory (THI).  

3. Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting Commun Med (2025). https://doi.org/10.1038/s43856-025-00837-3 

4. https://www.nidcd.nih.gov/health/tinnitus 

5. https://www.nyc.gov/assets/doh/downloads/pdf/survey/survey-2013noise.pdf 

6. Boedts, M. Beuchner, A. et al. Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial. Nature communications (2024) 

7. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020) 

8. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep. 

9. US VA Benefits Report Fiscal Year 2024: https://www.benefits.va.gov/REPORTS/abr/ 

10. Zeman, F. et al, Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? https://pubmed.ncbi.nlm.nih.gov/21493265/ (2011). 

11. A. McCombe et al., Guidelines for the grading of tinnitus severity, Clin. Otolaryngol. 2001, 26, 388 – 393 

About Neuromod   

Founded in 2010, Neuromod Devices is a global medical technology company. Neuromod has offices in Ireland, and the United States of America. The company specializes in the design and development of neuromodulation technologies. These technologies address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. 

The lead application of Neuromod’s technology is in the field of tinnitus. Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromoddevices.com. 

About Lenire^® 

Lenire^® is the first non-invasive bimodal neuromodulation tinnitus treatment device. The device has demonstrated its ability to soothe and relieve tinnitus in large-scale clinical trials.

Bimodal neuromodulation stimulates nerves using two paired stimuli for therapeutic purposes. Neuromod Devices developed Lenire, the tinnitus treatment device used in the study. Lenire consists of wireless (Bluetooth ®) headphones that deliver sequences of audio tones to both ears. The device delivers electrical stimulation pulses to the surface of the tongue through 32 electrodes, which are part of a proprietary device trademarked as Tonguetip®. Clinicians can configure the device’s settings to deliver treatment using different combinations of audio and electrical stimuli.

An easy-to-use handheld controller controls the timing, intensity, and delivery of the stimuli. Clinicians train each participant to use it before continuing treatment at home. Appropriately qualified healthcare professionals, such as ENTs or audiologists, prescribe Lenire after conducting a suitability assessment. Patients then complete treatment from the comfort of their own home.

Lenire has the largest volume of clinical trial and real world evidence for a bimodal neuromodulation device. 

Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. The US FDA awarded Lenire a De Novo Approval Grant.

About Tinnitus 

Tinnitus, known as ‘ringing in the ears,’ is a neurological condition where a person perceives sound without an external source. Researchers estimate that at least 25 million Americans currently live with tinnitus. The United States Veterans Administration (VA) compensates tinnitus as its most prevalent service-connected disability. More than 3.2 million veterans compensated in 2024.⁹ 

About Dr. Craig Kasper Au. D. 

Dr. Craig Kasper, Au. D. is the founder and managing director of audiology clinic, New York Hearing Doctors & Institute for Hearing and Balance. He is also the owner and found of New York Hearing Doctors | Tinnitus Care, based in New York. 

He earned his Doctorate of Audiology from the University of Florida. Dr. Kasper also holds a master’s degree with clinical honors from the State University of New York at Buffalo. 

Dr. Kasper’s extensive experience includes a Clinical Fellowship and clinical practice. This is held in the Department of Otolaryngology/Head & Neck Surgery at New York-Presbyterian Medical Center. Dr. Kasper is a Distinguished Fellow of the National Academies of Practice. He is also a Fellow of the American Academy of Audiology (AAA), Dr. Kasper is a member of the Academy of Doctors of Audiology (ADA). 

Dr. Kasper’s contributions extend beyond clinical practice; he has authored scholarly articles published in prestigious peer-reviewed journals such as Hearing Research and Laryngoscope and has been an invited presenter for professional conferences since the start of his career. Committed to public health education, he has also frequently served as a resource for the popular media on topics related to hearing health and wellness. 

• Lenire is now Tinnitus UK’s safest and most effective tinnitus treatment option following a review of the charity’s rating system.
• Tinnitus UK’s new rating acknowledges Lenire’s large-scale clinical trials involving 600+ people and the device’s effectiveness in the real world.^1,2,3
• Neuromod’s research for Lenire stands up to serious scrutiny per Tinnitus UK CEO, Alex Brooks-Johnson.

Dublin, Ireland – November 4, 2025: Tinnitus UK, Europe’s leading tinnitus advocacy body, has announced that Lenire by Neuromod is now the highest rated available tinnitus treatment option for safety and effectiveness as part of the charity’s treatment rating review.

Lenire is now considered to be very safe, with a level of efficacy currently matched only by professional cognitive behavioural therapy (CBT) and hearing aids. 

“Neuromod welcomes Tinnitus UK’s decision to recognise Lenire, and bimodal neuromodulation, as a safe and effective standard of care for tinnitus treatment,” said Neuromod founding CEO, Dr. Ross O’Neill. “Millions of people in the UK and across Europe rely on Tinnitus UK for advice about treatment options and we are delighted that Neurmod’s commitment to building compelling evidence is reflected in this new rating for Lenire.”

Lenire Tinnitus UK Reputation Built on Years of Research

Lenire^® is a bimodal neuromodulation device that is proven to provide long lasting relief from tinnitus. Lenire treats tinnitus through a combination of auditory and tongue stimulation that retrains the brain to significantly reduce tinnitus focus.

The device has been proven safe and effective with real world patients and across three large-scale clinical trials featuring more than 600 patients.^1,2,3 Tinnitus UK’s rating acknowledges Lenire’s body of evidence according to Tinnitus UK CEO, Alex-Brooks Johnson.

“Tinnitus UK’s vision is for a world without tinnitus, so new, rigorous research is welcomed with open arms. This change to the charity’s assessment of Lenire recognises years of hard work, building an evidence base that stands up to serious scrutiny.” said Tinnitus UK CEO, Alex Brooks-Johnson. “We hope it encourages other researchers and companies to do the same – to take tinnitus seriously, and give people living with tinnitus the treatment options that they need and deserve.”

Lenire is Proven with Real World Patients and in Clinical Trials

Lenire’s most recent clinical trial, TENT-A3, was a controlled clinical trial that was published in Nature Communications. TENT-A3 found Lenire was clinically superior to sound-only, the trial’s control, for the majority of patients with bothersome tinnitus.³

Nature – Scientific Reports published results from Lenire’s second large-scale clinical trial, TENT-A2. TENT-A2 showed 95% of treatment compliant patients reported tinnitus improvement. ² 91% reported long-term relief that sustained for at least a year after treatment ended.²

Analysis of 220 real world Lenire patients further validated Lenire’s effectiveness as a tinnitus treatment device. The analysis was peer-reviewed and published in Nature Communications Medicine. It showed that 91.5% of patients treated with Lenire had a clinically significant reduction in tinnitus after treatment with Lenire.⁴

“It’s fantastic to have Lenire as a tinnitus relief offering in our clinic, even more so now that it has been recognised by Tinnitus UK,” said owner of Byrom Audiology and Tinnitus UK Advisory Board Member, Peter Byrom. “It stands on years of rigorous research and we have seen life-changing results with our clients.”

Lenire is Available Across the UK, US, and Europe

Lenire is exclusively available through hearing healthcare professionals across the United Kingdom, Europe, and the United States of America. Tinnitus patients who wish to be assessed for Lenire can find a specialised clinic at www.lenire.com/find-a-clinic/. 

About Neuromod

Neuromod is a global medical technology company with offices in Ireland and the USA. The company specializes in the design and development of neuromodulation technologies to address the clinical needs of tinnitus patients. 

Neuromod has completed extensive clinical trials to confirm the safety and effectiveness Lenire. Lenire is its non-invasive bimodal neuromodulation tinnitus treatment device.  

For more information about Neuromod visit www.neuromod.com. 

About Tinnitus UK

Tinnitus UK, an independent charity dedicated to providing information and support for individuals living with tinnitus in the United Kingdom. Tinnitus UK plays a crucial role in enhancing the quality of life for those affected by this condition. 

The charity strives to facilitate improved well-being through a variety of support avenues. These include online and in-person support groups, a helpline featuring a chatbot and live webchat, and an informative website.

Tinnitus UK, receives no direct government funding. Tinnitus UK is committed to educating both medical professionals and the wider community about tinnitus. This includes advocating prevention, and working towards finding a cure.

About Tinnitus 

Tinnitus is commonly known as ‘ringing in the ears’. It is a complex neurological condition that causes a perception of sound when there is no external source. An estimated 15% of the global adult population has tinnitus.⁵

References

1. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)  
2. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, nature.com/articles/s41598-022-13875-x (2022)
3. Boedts, M., Beuchner, A., Khoo, S.G. et al Combining sound with tongue stimulation for the treatment of tinnitus. A multi-site single-arm controlled pivotal trial. Nature communications (2024) 
4. Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment, Commun Med (2025)
5. R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021)

• Neuromod launches Tinnitus Masterclass, an online course that features a blend of medical and commercial tinnitus modules.
• Tinnitus Masterclass is aimed at audiologists and ENTs who wish to offer, or expand, tinnitus care in their clinic.
• Tinnitus Masterclass improves tinnitus care accessibility by providing hearing care professionals with expert knowledge to introduce tinnitus care in their clinic.

Dublin, Ireland, October 21 2025: Neuromod, the medical device company that created the Lenire tinnitus treatment device, has launched Tinnitus Masterclass, an online course that provides hearing care professionals with expert clinical and commercial knowledge to introduce effective and sustainable tinnitus care services in their clinic.

Tinnitus Masterclass is an expert-led online course that blends audiology, neurology, and psychology. The course features short, focused modules that cover tinnitus aetiology, assessment, treatment options, and patient guidance. To support the commercial viability of tinnitus services in clinical practice, Tinnitus Masterclass also features modules on economics of tinnitus, defining service offerings, and marketing specialised tinnitus care.

Tinnitus Masterclass Increases Tinnitus Care Accessibility

Tinnitus, commonly known as ringing in the ears, is a medical condition that impacts 15% of the global adult population¹. Despite this prevalence, nearly half of all tinnitus patients had to wait more than two months or more for specialist tinnitus care per a 2024 Tinnitus UK report².

Neuromod’s Director of Clinical Affairs and Tinnitus Masterclass coordinator, Dr. Jakob Kümmel, believes that Tinnitus Masterclass helps to grow access to tinnitus services:

“Neuromod created the Tinnitus Masterclass to empower hearing-care professionals with the knowledge, confidence, and tools to deliver truly patient-centered tinnitus care,” said Dr. Kümmel. “Our goal is to raise the standard of tinnitus care globally – enabling clinicians to bridge science, evidence, and empathy while developing models of care that are both effective for patients, and viable for their practices.”

A Tinnitus Curriculum Developed by Experts

Tinnitus Masterclass was developed by Neuromod in collaboration with leading tinnitus clinicians, researchers, and business professionals.

Contributors include Dr. Jason Leyendecker AuD, Academy of Doctors of Audiology Past President and Tinnitus & Hyperacusis Clinic owner, Dr. Melissa Wikoff AuD, Peachtree Audiology owner, Dr. Emily E. McMahan, Audiology Practice Standards Organization President and Alaska Hearing & Tinnitus Center owner, Prof. Gail Whitelaw, American Academy of Audiology Past President and Speech-Language-Hearing Clinic Director at The OSU, and Dr. Jennifer Gans PhD, Mindfulness Based Tinnitus Stress Reduction creator.

The access-anywhere course combines expertise from experienced tinnitus practitioners with Neuromod’s experience from delivering tinnitus training to hundreds of hearing healthcare professionals, and conducting extensive research in the field of tinnitus.

Neuromod has conducted three large scale clinical trials for Lenire. Lenire is the first and only FDA approved bimodal neuromodulation tinnitus treatment device. These trials demonstrated the effectiveness and safety of Lenire across more than 600 tinnitus patients.^3,4,5,

Lenire’s real world effectiveness is consistent with outcomes reported in Lenire’s large-scale clinical trials. ⁶ These results are owed to a combination of clinical expertise, and rigorous training delivered by Neuromod.

In addition to successful patient outcomes, practices providing specialised tinnitus care, such as Lenire, have grown their patient-base and commercially matured their business.

“Demand for tinnitus care from expert clinicians is significant. Building the knowledge and confidence of clinicians interested in helping tinnitus patients is critical to serving the global patient population,” said Dr. Ross O’Neill PhD, Neuromod Founding CEO.

“Tinnitus Masterclass delivers this by combining expertise from some of the most experienced tinnitus clinicians practising today with Neuromod’s significant experience training audiology and ENT practices in clear, practical lessons”.

Enrol in Tinnitus Masterclass

Hearing healthcare professionals can register for Tinnitus Masterclass at neuromod.com/tinnitus-masterclass.

Tinnitus Masterclass is accessible via web browser or mobile app on iOS or Android. Tinnitus Masterclass is currently available to European healthcare professionals in English with additional languages and regions in development.

About Neuromod

Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, Germany and America. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations.

The lead application of Neuromod’s technology is in the field of tinnitus. Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromod.com.

Neuromod Launches Tinnitus Masterclass References

1. Tinnitus UK, Struggle for Silence Report, https://tinnitus.org.uk/wp-content/uploads/2024/02/TINNITUS-WEEK-2024-REPORT-V8c.pdf (2024).
2. Global Prevalence and Incidence of Tinnitus. A Systematic Review and Meta-analysis, JAMA (2022).
3. Conlon, B. et al. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Scientific Reports 12, 10845 (2022).
4. Conlon, B. et al. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Science Translational Medicine 12, eabb2830 (2020).
5. Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation clinically improves tinnitus symptoms in a controlled pivotal trial. Nature Communications (2024).
6. Mc Mahan, E., Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting Commun Med (2025). https://doi.org/10.1038/s43856-025-00837-3

• MDSAP certification is an essential milestone towards commercialisation of the Lenire tinnitus treatment device in Australia and Canada. 

• Following MDSAP certification, Neuromod Devices have secured regulatory approval for Lenire from both Australia’s Therapeutic Goods Administration (TGA) and Health Canada. 

• MDR certification supports the continued availability of Lenire in the European market and enables further availability of Lenire beyond Europe. 

• Lenire made regulatory history in 2023 by becoming the first and only FDA Approved bimodal neuromodulation tinnitus treatment device. 

DUBLIN, Ireland — September 24, 2025: Neuromod Devices, the medical device company that created the Lenire^® tinnitus treatment device, has announced approval to the Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulation (MDR) certification. 

MDSAP Creates Pathway for International Commercialisation

Neuromod’s MDSAP certification comes following a comprehensive audit verifying compliance with the international standard ISO13485 and specific regulatory requirements in multiple regulatory jurisdictions including Canada (Health Canada), and Australia (TGA). Following MDSAP certification Neuromod secured both Health Canada and TGA approval to place Lenire on the market in those territories. 

Tinnitus, which is commonly known as ringing in the ears, is a complex neurological condition that affects 15% of the global adult population¹. 

“Neuromod’s commitment to delivering the highest quality of patient care begins with ensuring our quality management systems are best-in-class,” said Dr. Ross O’Neill, Neuromod Founder & CEO. “MDSAP and MDR certification allows Neuromod to continue expanding Lenire’s availability in Europe while positioning the company to commercialize Lenire in new geographies such as Australia, Canada and beyond.” 

Continued Availability of Lenire in Europe

MDR governs the market placement, safety, and performance of medical devices in Europe, replacing Europe’s previous Medical Device Directive (MDD) as the current regulatory framework. MDR introduced significantly more rigorous requirements than MDD to ensure the safety, quality, and reliability of medical devices throughout their lifecycle.

Neuromod’s MDR compliance demonstrates the organisation’s regulatory and product quality standards.

MDR ensures Lenire’s continued European availability, provides a robust regulatory framework for future product development of the device. It also positions Neuromod to further expand the availability of Lenire in markets that use MDR’s CE-mark as a basis for regulatory approvals. 

“Neuromod’s simultaneous approval to MDR and MDSAP assures our healthcare provider partners, and their patients, that Lenire meets the highest safety, quality, and evidence threshold for a tinnitus treatment device,” said Diarmuid Flavin, Neuromod’s Chief Operating Officer. “The transition from MDD to MDR in Europe introduced more rigorous standards for medical device approval. Globally, many non-European markets recognise these standards which paves the way for us to make Lenire available to more people living with tinnitus worldwide.” 

Lenire’s Regulatory Approvals History

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials. In 2023, Lenire made regulatory history. The device became the first and only bimodal neuromodulation device to be granted De Novo approval by the US FDA.  

The De Novo grant was awarded based on the results of TENT-A3. TENT-A3 is a controlled clinical trial of the novel tinnitus treatment device.   

Nature Communications Medicine recently published the results of 220 tinnitus patients treated with Lenire in a real-world clinical setting at Alaska Hearing & Tinnitus Center. 91.5% of patients reported clinically meaningful reductions in tinnitus after treatment with Lenire². These results are consistent with Lenire’s large-scale clinical trials^3,4.   

For more information about Neuromod’s quality and regulatory standards, visit Neuromod’s Quality and Regulatory page. 

About Neuromod 

Neuromod is a global medical technology company with offices in Ireland and the USA. The company specializes in the design and development of neuromodulation technologies to address the clinical needs of tinnitus patients. 

Neuromod has completed extensive clinical trials to confirm the safety and effectiveness of its non-invasive bimodal neuromodulation tinnitus treatment device, Lenire.  

For more information about Neuromod visit www.neuromod.com. 

About Lenire 

Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials. 

Bimodal neuromodulation is the stimulation of nerves with two paired stimuli for therapeutic purposes. The tinnitus treatment device that was used in the study, known as Lenire, was developed by Neuromod Devices. It consists of wireless (Bluetooth ®) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device trademarked as Tonguetip®. The device’s settings can be configured to provide treatment with different combinations of audio and electrical stimuli. 

The timing, intensity and delivery of the stimuli are controlled by an easy-to-use handheld controller. Each participant is trained to use prior to continuing treatment from home. Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an Audiologist or ENT Surgeon. Patients can qualify for Lenire after an asssessment. Treatment is then completed at home in between follow-up appointments with their clinician. 

About Tinnitus 

Tinnitus is commonly known as ‘ringing in the ears’. It 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 Americans are currently living with tinnitus⁵.

Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA). More than 3.2 million veterans compensated in 2024⁶. 

Neuromod Regulatory Approvals References

1. Global Prevalence and Incidence of Tinnitus. A Systematic Review and Meta-analysis, JAMA (2022). 

2. Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting, Commun Med (2025). 

3. Brendan Conlon et al. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study.Sci. Transl. Med.12,eabb2830(2020).DOI:10.1126/scitranslmed.abb2830 

4. Conlon, B., Hamilton, C., Meade, E. et al. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Sci Rep 12, 10845 (2022). https://doi.org/10.1038/s41598-022-13875-x 

5. https://www.nidcd.nih.gov/health/tinnitus 

6. US VA Benefits Report Fiscal Year 2024: https://www.benefits.va.gov/REPORTS/abr/  

• Neuromod has announced 19 new clinical partnerships to increase access to the Lenire^® tinnitus treatment device.
• Partnerships with clinics in Spain, Belgium, Switzerland, Austria, Italy, Ireland, and the UK brings the number of European locations where Lenire is available to 50.
• Lenire^® was proven to provide long-term relief from tinnitus that sustains for at least 12-months after treatment concluded in 91% of patients in its second clinic trial.^3,6
• 91.5% of 220 real world patients treated with tinnitus had a clinically meaningful reduction in tinnitus after treatment with Lenire finds peer-reviewed study.^4,6

Neuromod Devices, the technology company that specialises in medical devices for tinnitus treatment, has announced 19 new clinical partnerships to expand the availability of the Lenire tinnitus treatment device in Europe.

This latest expansion will significantly increase the number of clinics providing Lenire across Europe. Countries include Ireland, Spain, Italy, Belgium, Switzerland, Austria, and the United Kingdom.

“Tinnitus is one of the largest unmet needs in hearing healthcare and the prevalence of tinnitus is growing worldwide,” said Dr. Ross O’Neill, Neuromod Devices Founder and CEO. “These partnerships ensure that European tinnitus patients have access to a proven tinnitus treatment option with guidance from leading tinnitus care professionals.”

Lenire Available in Leading Tinnitus Clinics

Tinnitus, commonly known as “ringing ears,” is a condition that causes the constant perception of noise with no source. Approximately 65 million people are living with tinnitus in Europe.¹

Jordon Thompson, Partner at Harley Street Hearing & Musicians’ Hearing Services, a new clinical partner based in London, spoke about the impact that Lenire has had on the clinic’s tinnitus patients.

 “Harley Street Hearing & Musicians’ Hearing Services has been supporting tinnitus patients for over 25 years,” said Jordon Thompson, Clinical Lead. “We introduced Lenire into our practice nearly a year ago, and with Neuromod’s support our team quickly built confidence in this advanced technology. We are already seeing successful outcomes that are helping patients manage tinnitus more effectively.”

Lenire Proven in Clinical Trials and with Real World Patients

Lenire^® is a bimodal neuromodulation device which has been proven to provide long lasting relief from tinnitus. The device is proven in multiple large-scale clinical trials. Lenire treats tinnitus through a combination of auditory and tongue stimulation that retrains the brain to significantly reduce tinnitus focus.

Lenire has been proven safe and effective in clinical trials in three large-scale clinical trials that featured more than 600 patients.^3,4,5,6,7

Lenire’s most recent clinical trial, TENT-A3, was a controlled clinical trial. TENT-A3 found Lenire was clinically superior to sound-only, the trial’s control, for the majority of patients with bothersome tinnitus. Results from TENT-A3 were published in Nature Communications Medicine.^5,6

Results from Lenire’s second large-scale clinical trial, TENT-A2, were published in Nature – Scientific Reports. TENT-A2 showed 95% of treatment compliant patients reported tinnitus improvement. 91% of whom reported long-term relief that sustained for at least a year after treatment ended.^3,6

Analysis of 220 real world Lenire patients further validated Lenire’s effectiveness as a tinnitus treatment device. The analysis, peer-reviewed and published paper in Nature Communications Medicine, showed that 91.5% of patients treated with Lenire had a clinically significant reduction in tinnitus after 12-weeks of treatment with Lenire.^4,6

Lenire is now available through hearing and tinnitus care clinics across Europe. Tinnitus patients can find a nearby clinic, and book an appointment by visiting www.lenire.com/find-a-clinic.

About Neuromod

Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, Germany and America. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations.

The lead application of Neuromod’s technology is in the field of tinnitus. Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromod.com.

About Lenire^®

Lenire^® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials.

Lenire^® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Lenire has also received a De Novo Approval Grant by the US FDA. Further details about Lenire^® including a list of providers can be found at www.lenire.com.

References

1. Lancet Reg Health Eur.. 2021 Nov 4:12:100250. doi: 10.1016/j.lanepe.2021.100250. eCollection 2022 Jan.
2. R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021), https://doi.org/10.1016/j.lanepe.2021.100250
3. 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)
4. Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting Commun Med (2025). https://doi.org/10.1038/s43856-025-00837-3
5. Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024)
6. As measured by Tinnitus Handicap Inventory (THI).
7. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

• Financing led by existing investors Fountain Healthcare Partners and Panakès Partners
• Neuromod will use funds to accelerate commercialisation in the USA and Europe.

Dublin, Ireland, 11 March 2025: Neuromod Devices Ltd. (Neuromod), an Irish medical device company specialising in tinnitus, has successfully closed a €10 million equity financing to expand the availability of its tinnitus treatment device, Lenire.

Oversubscribed Financing to Drive Commercialisation

Neuromod has raised €10 million of equity in an expansion of its Series B fundraisings. The financing was oversubscribed and was led by existing investors Fountain Healthcare Partners and Panakès Partners, backing Neuromod’s mission to advance tinnitus care for patients globally.

Neuromod has been making Lenire available through audiology and ENT practices throughout the USA and Europe. Proceeds from the financing will be used to meet demand for Lenire through sustainable commercial expansion in the USA and Europe and expand on existing opportunities in the US Department of Veteran Affairs (USVA).

Following FDA approval in March 2023, more than 100 clinics throughout the USA now treat tinnitus patients with Lenire. Availability of Lenire has also expanded in Europe with clinics in 14 countries now using the device. In the last 6 months, the number of clinics in the UK trained to use Lenire has doubled, and it is available to patients in Sweden for the first time.

In June 2024, Neuromod was awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making Lenire a treatment option for the 2.9 million US Veterans living with tinnitus ⁵ through the USVA.

35 USVA facilities have been trained to provide treatment with Lenire with more scheduled for training in 2025.

Real-World Evidence – Substantial Momentum

Positive results for tinnitus patients treated with Lenire in real-world settings at independent USA-based clinics have been compiled with a base of over 1,500 patients that continues to grow.

In what will be the first of a series of planned real-world evidence publications, results from Alaska Hearing & Tinnitus Center showed that 91.5% of 220 patients reported clinically significant improvement in their tinnitus ⁶. This data is consistent with, and in many instances outperforms, data from Lenire’s large-scale clinical trials.

These results followed the publication of Lenire’s pivotal controlled clinical trial results, which led to US FDA approval and featured as the cover-story in peer-reviewed journal, Nature Communications ⁴. This article is in the 99th percentile of more than 250,000 tracked Nature articles.

Neuromod Closes €10m Financing Comments

Commenting on the news, Dr. Ross O’Neill PhD, Founder & CEO of Neuromod said “We are delighted to announce an oversubscribed financing at a pivotal time when we are driving forward with our mission of making Neuromod the category creator for tinnitus globally.”

“Tinnitus is the largest unmet need in hearing healthcare globally and is the number one service-connected disability among US veterans and military personnel. I am proud of the progress Neuromod is making to deliver our market-surpassing treatment to as many tinnitus patients as possible while enabling care providers’ expertise to be commercially rewarded. I am also grateful for the continued support of our investors who share our vision of advancing tinnitus care globally.” Dr. O’Neill continued.

Dr. Manus Rogan, Chairman of Neuromod and Managing Partner of Fountain Healthcare Partners commented, “Recent results from tinnitus patients using Lenire in the real-world show that it represents a new standard of care for tinnitus. The successful closing of this financing ensures more patients will get access to this standard of care as quickly as possible.”

Alessio Beverina, Managing Partner of Panakès Partners said, “Panakès is pleased with the progress of Neuromod since our investment, with significant clinical trial, FDA approval, real-world evidence, and commercial success in both Europe and the USA; and it is proud to continue supporting Neuromod’s work to bring a new standard of care to a historically underserved patient population.”

Emily E. McMahan, Owner of Alaska Hearing and Tinnitus Center and author of the clinic’s Real World Evidence Paper said, “Impressive clinical trial results for Lenire led me to early adoption of the landmark tinnitus treatment technology.”

“In my clinic, and my colleagues’ clinics, we are seeing results that are superior to clinical trial results.” Dr. McMahan continued.

About Neuromod Devices Ltd

Neuromod is a medical technology company with headquarters in Dublin, Ireland. Neuromod specialises in the design, development, and commercialisation of neuromodulation technologies. This is to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions.

The lead application of Neuromod’s technology is in the field of tinnitus. Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromod.com.

About 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. Tinnitus affects an estimated 15% of the global adult population¹.

The management of tinnitus poses significant burden on healthcare systems. A 2021 study estimated the socioeconomic costs of tinnitus in Germany at €21.9 billion per annum⁷. In the USA it’s estimated the Veterans Benefits Administration paid out approximately $5.8 billion through its Veterans Compensation benefits program for tinnitus in 2023⁵.

The American Tinnitus Association, the leading advocacy body in the USA for people living with the condition, has recently revised its estimate that 50 million Americans live with tinnitus upward to 70 million⁸.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to relieve tinnitus in a large-scale clinical trial. Lenire works by delivering mild pulses to the tongue, through a component called the ‘Tonguetip®’. This is combined with auditory stimulation through headphones. This combination drives changes in the brain to treat tinnitus. To date, the device has been used in large-scale clinical trials with over 700 patients^{2, 3 ,4}.

Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Lenire has received a De Novo grant of approval by the US FDA. Further details about Lenire including a list of providers can be found at www.lenire.com.

Connect with Neuromod

• LinkedIn: linkedin.com/neuromod
• X: x.com/NeuromodDevices
• Facebook: facebook.com/neuromoddevices/

References & Notes

• 1. Baguely et al., Tinnitus, The Lancet (2013), sciencedirect.com/science/article/pii/S0140673613601427
• 2. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
• 3. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, doi.org/10.1038/s41598-022-13875-x (2022)
• 4. Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024)
• 5. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/
• 6. McMahan, E.E. and Lim, H.H., 2024. Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in United States. A retrospective chart review. medRxiv., pp.2024-08; doi: https://doi.org/10.1101/2024.08.22.24312175 [preprint]
• 7. Tziridis K, Friedrich J, Brüeggemann P, Mazurek B, Schulze H. Estimation of Tinnitus-Related Socioeconomic Costs in Germany. Int J Environ Res Public Health. 2022 Aug 22;19(16):10455. doi: 10.3390/ijerph191610455. PMID: 36012089; PMCID: PMC9407899.
• 8. https://www.linkedin.com/posts/patrickalynch_tinnitus-activity-7270503831304654848-VbWN/