Neuromod

Revolutionising Tinnitus Care

Neuromod is a global medical technology company with offices in Ireland, Germany and the United States of America. Neuromod is the standard bearer for scientifically proven tinnitus treatment.

Through the development of innovative technology, investment in clinical research, and collaboration with leading hearing and tinnitus care professionals, Neuromod is redefining tinnitus care.

Lenire Tinnitus Treatment Device

Lenire is a non-invasive, at-home bimodal neuromodulation tinnitus treatment device that has been proven in large-scale clinical trials and with real world patients.

Lenire® combines mild pulses to the tongue, through an intraoral Tonguetip®, with auditory stimulation through headphones to drive relief from tinnitus. This combination of stimuli is known as bimodal neuromodulation.

In 2023, Lenire became the first device of its kind approved for the treatment of tinnitus in the USA following a De Novo grant from the US FDA. Lenire also has CE-mark certification and is available under the supervision of a qualified healthcare professional throughout Europe and the USA.

How Does Lenire Work?

Lenire’s bimodal neuromodulation stimulates the auditory and somatosensory nerves at once. This dual stimulation leverages the brain’s neuroplasticity to reduce focus on tinnitus.

Lenire’s proprietary audio plays through bluetooth headphones to stimulate the auditory nerve and this is combined with mild pulses to the surface of the tongue using a small intra-oral Tonguetip®.

Lenire is used for two 30-minute sessions per day for a period of time recommended by a hearing healthcare professional. Patients are guided through the process by a tinnitus expert.

Patients attend regular follow-up appointments to benchmark their tinnitus as they use Lenire.This has been proven to provide significant relief from tinnitus.^1,2,3,4

Lenire: Evidence Based Tinnitus Treatment Technology

Lenire has the largest volume of evidence for a tinnitus treatment device in existence. Lenire has been subject to three large-scale clinical trials and has had real world evidence peer-reviewed and published in prestigious scientific journals.

Both clinical trial and real world evidence supports Lenire as an effective tinnitus treatment. Here are some key takeaways from Lenire’s research:

TENT-A1 Clinical Trial: 86% of patients reported a reduction in tinnitus severity, 80.1% of whom reported relief that sustained for at least 12 months post-treatment.  This was the cover story in Science Translational Medicine.
TENT-A2 Clinical Trial: 95% of TENT-A3 participants reported tinnitus improvement, 91% of whom had relief that sustained for at least 12-months. Nature – Scientific Reports peer-reviewed and published TENT-A2.
TENT-A3 Controlled Clinical Trial: 70% of patients with moderate or worse tinnitus had clinically meaningful relief from tinnitus with Lenire. This is compared with negligible improvement from sound-therapy, the trial’s control. TENT-A3 was pivotal in Lenire being awarded a De Novo Approval Grant from the US FDA. Nature Communications peer-reviewed and published TENT-A3.
Peer Reviewed Real World Data: 91.5% of 220 real world patients treated with Lenire reported significant relief from tinnitus. Nature Communications Medicine peer-reviewed and published this real world evidence.

Visit lenire.com/clinical-trials to learn more about Neuromod’s commitment to advancing the science of neuromodulation for tinnitus treatment.

Neuromod Scientific Advisory Board

Neuromod Devices assembled a Science Advisory Board of opinion leading scientists in the field of tinnitus research to provide guidance on the company’s research. This Scientific Advisory Board includes Professor Berthold Langguth, Prof. Sven Vanneste, and Prof. Deborah Hall.

Where Can Tinnitus Patients Access Lenire?

Lenire is available exclusively through the following qualified tinnitus care providers in Europe and the United States of America. Patients must attend a tinnitus assessment to see if Lenire is the right fit for their tinnitus.

You can find an expert tinnitus clinic near you by visiting lenire.com/find-a-clinic.

How Can Hearing Healthcare Professionals Provide Lenire?

Hearing care professionals interested in providing the Lenire tinnitus treatment device can register their interest, and a member of the team will be in touch.

Neuromod helps Lenire Providers position their practice as a leader in tinnitus care, and ensure tinnitus patient outcome excellence with Neuromod Clinical Support

Lenire Onboarding: Comprehensive onboarding, and an online tinnitus and Lenire learning platform.
Lenire Network: Access a global network of tinnitus experts, KOLs, and referring healthcare providers.
Lenire Support: Our dedicated clinical affairs and technical support allows you to focus on patient care.

Neuromod is a partner in tinnitus care excellence ensuring that Lenire can help you serve your tinnitus patients, and grow your clinic.

Journal
Resources

News

Tinnitus UK Rates Lenire as Most Effective Treatment Option
November 5, 2025 Lenire by Neuromod is now the highest rated available tinnitus treatment option for safety and effectiveness

Neuromod Launches Online Tinnitus Masterclass
October 21, 2025 Neuromod 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.

Neuromod Advance Multiple Regulatory Approvals to Expedite Global Availability of Lenire
September 23, 2025 Lenire made regulatory history in 2023 by becoming the first and only FDA-approved bimodal neuromodulation tinnitus treatment device.

Neuromod Expands Availability of Lenire Tinnitus Treatment Device in Europe with 19 New Clinical Partnerships
September 16, 2025 Neuromod Devices announced 19 new clinical partnerships to expand the availability of the Lenire tinnitus treatment device in Europe.

Nature Communications Medicine Publishes Positive, Real World Data for Tinnitus Patients Treated with Unique, FDA Approved Stimulation Device
April 28, 2025 Nature Communications Medicine has published the first peer reviewed, real-world analysis of U.S. patients treated with Lenire, the only FDA approved tinnitus treatment device of its kind.

Lenire Supports Veterans by Sponsoring Hearoes Tour
April 7, 2025 Lenire proudly sponsors the 10th Annual LexCare Hearing Foundation Hearoes Tour. Lenire is a treatment option for 3.2m veterans living with tinnitus.

Neuromod Closes €10 Million Financing to Accelerate Commercialization
March 11, 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.

UK Clinics Providing Lenire Tinnitus Treatment Device Double in Latest Expansion
February 11, 2025 Neuromod Devices, the medical device company that specialises in tinnitus treatment, has announced they are partnering with 4 UK clinics to expand the availability of Lenire®, the clinically proven tinnitus treatment device.

Real World Data Supports Lenire Tinnitus Treatment Effectiveness Shown in Large-Scale Clinical Trials
September 4, 2024 The first real-world analysis of tinnitus patients treated with Lenire in the United States has been submitted to a journal for peer-review and is now available on an online pre-print server for health services, medRxiv.

Neuromod Partners with 14 New US Tinnitus Clinics to Expand Availability of FDA Approved Lenire
June 27, 2024 The number of practice partners providing Lenire across the USA has increased to more than 80 in Lenire’s second US expansion of 2024.Lenire will be expanding the number of clinics in California, Texas, Illinois, and Florida to address signific

FDA-Approved Lenire Tinnitus Device Now a Treatment Option for 2.9 Million US Veterans Through Veterans Affairs
June 17, 2024 Neuromod USA Inc. has been awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government

Breakthrough Tinnitus Treatment Device Lenire Expands Clinics in Spain
April 5, 2024 The breakthrough tinnitus treatment device, Lenire, is now available in four clinics in Spain – Barcelona, Malaga, Seville, and Granada. In Lenire’s second clinical trial, TENT-A2, 91% of patients reported long-term relief from tinnitus that sustained for at least 12 months. Lenire has been proven to be more effective than sound-alone for patients with moderate or worse tinnitus in a controlled large-scale clinical trial. Additionally, 88% of over 500 clinical trial patients would recommend Lenire to treat tinnitus. Lenire is the only tinnitus treatment device of its kind to be awarded a CE-Mark in Europe and FDA Approval in the United States of America.

FDA Approved Lenire Expands Number of US Clinics
February 29, 2024 Neuromod Devices, the medical technology company that developed tinnitus treatment device, Lenire, has partnered with an additional 24 new US clinics to address the significant demand for the FDA-approved tinnitus treatment device.

Lenire Now Available in Monaco Through Otoneuro
February 22, 2024 Neuromod Devices, the medical technology business behind tinnitus treatment device, Lenire, has partnered with state-of-the-art hearing and balance centre, Otoneuro, to make Lenire available in Monaco.

Neuromod Expands Lenire’s US Availability to More Than 50 Providers
October 10, 2023 Neuromod Devices has completed the training and onboarding of additional healthcare professionals in the USA to treat tinnitus patients with Lenire, its bimodal neuromodulation device.

Neuromod Devices Closes €30 Million Financing to Expand Availability of Tinnitus Treatment Device Lenire®
April 13, 2023 Neuromod Devices Ltd, an Irish medical device company specialising in neuromodulation, has successfully closed a €30 million financing to further commercialise its tinnitus treatment device, Lenire.

FDA Grants Lenire® Tinnitus Treatment Device De Novo Approval
March 7, 2023 Neuromod Devices Ltd. announced today that the US Food and Drug Administration (FDA) has granted De Novo approval to Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.

Neuromod Publishes Results of Second Large Scale Clinical Trial for Tinnitus in Top-Tier Scientific Journal, Shows Greater Improvement of Symptoms
June 30, 2022 Neuromod Devices Limited has published the results of the company’s TENT-A2 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A2) clinical trial in the highly regarded scientific journal, Nature.

Lenire®, the Treatment Device Shown to Reduce Tinnitus Symptoms in 86.2% Of Patients, Is Now Available in Norway
May 20, 2022 Lenire®, the treatment device shown to reduce tinnitus symptoms in 86.2% of patients, is now available in Norway.

Neuromod Establishes Global Commercial Leadership Team
April 7, 2022 Neuromod Devices Ltd. has announced the formation of a global commercial leadership team to direct the commercialization of its Lenire tinnitus treatment device through key partnerships.

Articles

Back from the Brink: A Case Report on Lenire® for Persistent Catastrophic Tinnitus in a Post-Stapedectomy Patient
October 6, 2025 Emily E. McMahan, AuD, ABA Certified, CH-AP, CH-TM As Lenire gains traction in clinical practice, real-world cases like this help clarify its role in managing complex tinnitus presentations, particularly following surgical interventions.

Resources

Hearing Aid Users Received Additional Benefit in Their Tinnitus Journey with Lenire® Bimodal Neuromodulation Treatment

Tinnitus, commonly known as ringing in the ears, is the phantom auditory sensation that affects 10–15% of the adult population.

January 28, 2025

Clinical Experience with Lenire - Case Report of a Patient with Catastrophic Symptom Severity

This real world case study details how Lenire helped a catastrophic tinnitus patient lower their THI score from 94 to 27.

December 20, 2023

Clinical Experience with Lenire®- Case Report of a Patient whose Vestibular Symptoms Improved

This real world case study details how a patient with tinnitus and vestibular condition lowered his tinnitus from 55 THI to 16 THI. As an unexpected side benefit, this patient also gained improved balance.

December 20, 2023

Psychotherapy Case Study of Patient attending Tinnitus Therapy (Otologie – Dublin)

A combination of cognitive behaviour therapy and Lenire helped a real-world patient lower their THI score from 66 to 14.

December 20, 2023

Contact Information

Neuromod

Revolutionising Tinnitus Care

Lenire Tinnitus Treatment Device

How Does Lenire Work?

Lenire: Evidence Based Tinnitus Treatment Technology

Neuromod Scientific Advisory Board

Where Can Tinnitus Patients Access Lenire?

How Can Hearing Healthcare Professionals Provide Lenire?

News

Articles

Resources