Category: 2026

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.