Lenire Tinnitus Treatment Device Now Available in Canada

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, April 7, 2026 /PRNewswire/ -- 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 with further expansion planned in 2026.

Lenire^® is the first bimodal neuromodulation device that has been proven to provide long-term relief from tinnitus across multiple clinical trials.^2,3 The device combines mild pulses to the surface of the tongue via an intra-oral component called the 'Tonguetip^®', with auditory stimulation to drive changes to the brain and 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 with 37% reporting 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).  

Lenire is Proven to Provide Long-Term Tinnitus Relief in Clinical Trials

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, 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 Following US FDA approval, the Lenire device was approved to the Medical Device Single Audit Program (MDSAP) and 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."

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 treated with Lenire at Alaska Hearing & Tinnitus. 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 treated at New York Hearing Doctors. 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 demonstrated to me that you can solve problems like tinnitus, it has been a miracle that has changed my life, "

Acknowledging the large evidence-based, Lenire has been rated as the top tinnitus treatment option for safety and effectiveness by leading tinnitus charity, Tinnitus UK.

Lenire is available in Canada exclusively through hearing care clinics 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. Neuromod 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 its non-invasive bimodal neuromodulation tinnitus treatment device, Lenire, to treat this common but underserved disorder.

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 that 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, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.

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) 

Photo: https://mma.prnewswire.com/media/2949293/Neuromod_Devices.jpg

View original content to download multimedia:https://www.prnewswire.com/news-releases/lenire-tinnitus-treatment-device-now-available-in-canada-302735534.html

SOURCE Neuromod Devices