Author: Neil Doyle

• 91.5% of patients experienced clinically meaningful reductions in tinnitus after 12 weeks of treatment with Lenire.
• 220 patients were analyzed, making the paper one of the largest real-world analyses of tinnitus patients ever published in a peer-reviewed scientific journal.
• Real-world outcomes in this paper are consistent with the results of Lenire’s large-scale clinical trials.

 
CHICAGO, 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.

Tinnitus afflicts an estimated 25 million American adults and is commonly described as “ringing” in the ears.

Results in the paper titled: “Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting” reported 91.5% of tinnitus patients had a clinically significant reduction in tinnitus. These real-world results are consistent with Lenire’s clinical trial results that were instrumental in Lenire being granted De Novo approval by the FDA in March 2023.

• The paper is available at Nature Communications Medicine: nature.com/articles/s43856-025-00837-3

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 typically use the device at home for two 30-minute sessions daily for an average of 12 weeks.

Real World Lenire Outcomes Consistent with Clinical Trials

The paper, co-authored by audiologist Emily E. McMahan, Au. D., of the Alaska Hearing and Tinnitus Center (AHTC) and Professor Hubert Lim, Ph. D., from the University of Minnesota, analyzed the results of 220 patients with moderate or worse tinnitus who were treated with Lenire at AHTC between May 2023 and June 2024.

This analysis is one of the largest ever conducted of real-world patients following their treatment for tinnitus with a medical device. After an interim check-up after six weeks of treatment with Lenire, 78% had a clinically meaningful reduction in tinnitus. After 12-weeks 91.5% of patients had a clinically meaningful reduction in tinnitus, which demonstrates the effectiveness of a typical treatment protocol with Lenire in a real-world clinical setting.^[1,5,6]

AHTC’s results are the first of a series of planned, real-world evidence publications that have been compiled with a base of thousands of patients treated with Lenire.

“Publication of this data in Nature Communications Medicine underscores how effective Lenire can be for tinnitus patients when they receive guidance from an experienced tinnitus care professional,” said audiologist and AHTC founder, Emily E. McMahan, Au. D. “I am confident we have entered an important new era of tinnitus care”.

Lenire FDA De Novo FDA Approval

FDA Approval in March 2023 was facilitated by Lenire’s controlled, TENT-A3 clinical trial. The results were published in Nature Communications, a journal from the same portfolio. The paper remains in the 99th percentile of more than 250,000 tracked Nature articles.^[2]

TENT-A3 included 112 trial participants and demonstrated Lenire’s clinical superiority to sound-only therapy, a widely used treatment for tinnitus.^[2,5] Nearly 89 percent of trial participants said they would recommend Lenire as a tinnitus treatment.^[2]

“To achieve real-world positive results that are better than what were observed in our previous controlled clinical trial that led to FDA authorization for the Lenire treatment is a major advancement for the tinnitus field,” said Neuromod Chief Scientific Officer and University of Minnesota Professor, Hubert Lim, Ph.D. “Publication of Lenire’s real-world data in a top-tier scientific journal further validates Lenire’s bimodal neuromodulation as a treatment option for tinnitus patients.”

According to Neuromod Devices founder and CEO, Dr. Ross O’Neill, who was Lenire’s principal inventor, “Fifteen percent of the global adult population experiences tinnitus, with many seeking better treatment options. These results show Lenire is successful treating tinnitus in real-world clinical settings”.

“As scientists and medical professionals, we are committed to evidence-based technology. Part of our DNA at Neuromod is working closely with a passionate network of tinnitus care experts. We train and qualify clinicians and provide ongoing support to help continuously improve clinical best practices and patient outcomes.”

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. Mc Mahan, E., and Lim, H., Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting Commun Med (2025). doi.org/10.1038/s43856-025-00837-3
2. 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)
3. nidcd.nih.gov/health/tinnitus
4. US VA Benefits Report Fiscal Year 2024: benefits.va.gov/REPORTS/abr
5. As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories.
6. Clinically meaningful reduction in tinnitus is defined as at least 7-points of improvement on the THI scale for the paper.

About Neuromod

Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. Neuromod specializes in the design and development of neuromodulation technologies 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, where 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 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.

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

For more information visit www.lenire.com.

About Tinnitus

Tinnitus, which is commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans are currently living with tinnitus.³ Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 3.2 million veterans compensated in 2024.^[4]

About Audiologist Emily E. McMahan Au. D.

Audiologist Emily E. McMahan, Au. D. the owner of Alaska Hearing and Tinnitus Center. Dr. McMahan specializes in Diagnostic Hearing & Hearing Management as well as Tinnitus and Tinnitus Management.

Dr. McMahan holds Board Certification in Audiology through the American Board of Audiology. She is a Fellow of the American Academy of Audiology and the Academy of Doctors of Audiology.

Dr. McMahan is past-President of Audiology Practice Standards Organization (APSO) which is a nationwide group dedicated to creating a national standard of care for the profession of Audiology.

Lenire, the first and only FDA Approved tinnitus treatment device of its kind, is proud to sponsor the 10th Annual LexCare Hearing Foundation Hearoes Tour. This sponsorship will raise awareness of, and access to, hearing and tinnitus care options for US Veterans.

The Hearoes Tour brings free hearing health resources, screenings, and guidance directly to veteran communities across America.

Hosting over 200 events annually, The Hearoes Tour removes accessibility barriers to hearing and tinnitus care. This is achieved by simplifying the process, addressing affordability, raising awareness of untreated hearing loss side effects, and increasing care access. To date, the Hearoes tour has conducted over 33,000 hearing screenings and hosted more than 1,000 free hearing health events.

“Nearly 40% of the veterans we’ve served through the Hearoes Tour have reported experiencing tinnitus and yet, for years, we had no real solution to offer them.” said Jaime Motes, Founder/Director, The LexCare Hearing Foundation.

“It’s personal for me — my daughter has cochlear implants because she was born deaf. She has an answer. Every veteran deserves an answer, too. Now, we finally do. Thanks to our partnership with Lenire we are finally able to connect veterans with real life-changing tinnitus treatment option after years of advocacy, awareness, and outreach.”

“This partnership is a milestone in our mission to eliminate the barriers to hearing and tinnitus care. Together, we are providing real hope and real solutions for those who have sacrificed so much.”

Tinnitus: The #1 Service-Connected Disability

Tinnitus is the number one service-connected disability compensated for by the VA since 1955. Veterans received an estimated $6.6 billion in service-connected compensation for tinnitus in 2024.1 63% of all auditory Veteran Compensation Claims were for tinnitus.¹

Neuromod, the medical device company behind Lenire, was awarded a FSS 65 II Medical Equipment & Supply Contract, making Lenire a treatment option for 3.2 million Veterans living with tinnitus through the Department of Veterans Affairs.¹

Lenire is the first bimodal neuromodulation device for tinnitus to receive a Federal Supply Schedule (FSS) Contract. 50 USVA facilities provide treatment with Lenire with more scheduled for training in 2025.

“Sponsoring the 10th Annual Hearoes Tour, and supporting the invaluable services The Lexcare Hearing Foundation provides, advances our commitment to veterans by increasing awareness and accessibility of life-changing hearing and tinnitus care treatment options.” said Eric Timm, Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations.

A New Category for Tinnitus Care

Positive results for thousands of tinnitus patients successfully treated with Lenire at independent USA-based clinics has been collected. This is part of a growing body of real-world evidence.

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. ²

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. These results led to De Novo US FDA approval and featured as the cover-story in peer-reviewed journal, Nature Communications. This article is in the 99th percentile of more than 250,000 tracked Nature articles.

About Neuromod

Neuromod is a medical technology company with headquarters in Dublin, Ireland. Neuromod specializes in the design, development, and commercialisation 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.
 

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 population.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire works by delivering mild pulses to the tongue, through an intra-oral component called the ‘Tonguetip®’, combined with auditory stimulation through headphones. This combination drives changes in the brain to treat tinnitus. 700 patients have participated in Lenire’s clinical trials.

Lenire has CE-mark certification for the treatment of tinnitus under the supervision of a qualified healthcare professional in Europe and has received a De Novo grant of approval by the US FDA. Further details about Lenire and Clinical Providers at www.lenire.com.

References

1. 1. https://www.benefits.va.gov/REPORTS/abr/docs/2024-abr.pdf
2. 2. https://doi.org/10.1101/2024.08.22.24312175

• FDA approval for the groundbreaking tinnitus treatment device, Lenire, was granted in March 2023 based on the success of the device’s large-scale controlled clinical trial, TENT-A3.¹
• TENT-A3 demonstrated that Lenire is more effective at providing relief from bothersome tinnitus than sound therapy alone, which was the trial’s control.
• No device-related serious adverse events were detected during TENT-A3.¹
• 88.6% of participants stated they would recommend Lenire to treat tinnitus.¹
• Lenire is available through specialized clinics in the United States of America and Europe. Further details about Lenire® can be found at www.lenire.com.

Chicago, Illinois, August 20, 2024: Nature Communications has published the peer-reviewed results of Neuromod Devices’ TENT-A3 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3) clinical trial for the first and only FDA-Approved bimodal tinnitus treatment device, Lenire.

The results published in the clinical trial paper titled: Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial, were central to Lenire’s successful De Novo US FDA Grant approval.

• Published Paper: Nature Communications

Lenire is a bimodal neuromodulation device which has been shown to provide relief from tinnitus that can sustain for at least 12-months after treatment in large-scale clinical trials.2,3 Lenire’s bimodal neuromodulation pairs mild electrical pulses to the tongue through an intra-oral component called the Tonguetip® with auditory stimulation through headphones.

TENT-A3 Lenire Controlled Clinical Trial Design

TENT-A3, Neuromod’s third large-scale clinical trial for Lenire was a controlled trial. The trial was conducted as part of Lenire’s De Novo US FDA submission at three independent sites. TENT-A3 took palce between March and October 2022 with 112 enrolled participants.

TENT-A3 compared Lenire’s bimodal neuromodulation mechanism to sound therapy. The trial was designed and executed with guidance from the US FDA. Participants were given six weeks of sound-only stimulation as a control condition, followed by six weeks of bimodal treatment where tongue stimulation was added to the sound component.

As part of Lenire’s successful De Novo submission, Neuromod was required to demonstrate that Lenire’s bimodal neuromodulation provided additional clinically significant benefit for tinnitus when compared to sound-only stimulation. TENT-A3 demonstrated that Lenire is clinically superior to sound-only stimulation for the majority of patients with moderate or worse tinnitus.

TENT-A3: Controlled Clinical Trail Results

Clinical trial data from Lenire’s De Novo submission further showed that 70.5% of participants with moderate or worse tinnitus who experienced no clinically meaningful improvement from six weeks of sound-only stimulation reported clinically significant improvement in their tinnitus severity following six weeks of treatment with Lenire.^5,7

The majority of participants with moderate or worse tinnitus who underwent six weeks of sound-only stimulation also reported that a further six weeks of treatment with Lenire provided additional benefit for their tinnitus.^1,5

Tinnitus, commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated at least 25 million Americans6 are currently living with the condition. Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA). More than 2.9 million veterans compensated in 2023.⁴

“Tinnitus is the largest unmet need in hearing healthcare,” said Neuromod Founding CEO, Dr. Ross O’Neill Ph.D., “Historically, tinnitus patients have been disappointed and frustrated by products that are neither backed by compelling clinical evidence, nor cleared by regulatory authorities. With the success of TENT-A3 and the first-of-its-kind De Novo FDA-Approval, Lenire is the only tinnitus treatment backed by multiple large-scale clinical trials and approved by the US Food and Drug Administration.”

Lenire: A Category Defining Tinnitus Intervention

In addition to the majority of participants benefitting from bimodal neuromodulation, 82.4% were compliant to bimodal treatment. 88.6% responded that they would recommend Lenire as a tinnitus treatment.¹

“Lenire’s FDA Approval combined with the rigorous design of the device’s controlled clinical trial were compelling factors when choosing to add Lenire to the treatment options at my clinic.” said Prof. Gail Whitelaw Ph.D., Clinic Director, Department of Speech and Hearing Science, The Ohio State University. “Lenire has been a landmark addition to my tinnitus toolbox and my patients have seen the benefits of overwhelmingly positive results.”

The positive efficacy, compliance, and safety findings for TENT-A3 were highly consistent with the real-world evidence from 204 patients included in Lenire’s successful De Novo submission to the US FDA. Across TENT-A3 and the Real-World Evidence, Lenire proved to be inherently safe with zero device-related serious adverse events1. These results build upon the success of two previous landmark clinical trials of Lenire that included more than 500 patients.^2,3

“The TENT-A3 controlled clinical trial was properly designed with expert guidance from the US FDA.” said Neuromod Chief Scientific Officer and University of Minnesota Professor, Prof. Hubert Lim, Ph.D., “This interactive collaboration enabled the success of Lenire’s De Novo FDA approval, which has further established Lenire as a category-defining tinnitus intervention.”

About Neuromod

Neuromod Devices is a global medical technology company with offices in Ireland and the United States of America. Neuromod specialises in the design and development of neuromodulation technologies. These 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. This is where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive technology. For more information visit Neuromod.

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. Lenire consists of wireless (Bluetooth®) headphones that deliver sequences of audio tones to both ears. This is 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. These include an Audiologist or ENT Surgeon, after an assessment for suitability. Treatment can be completed from home in between follow-up appointments with their clinician.

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 Approval Grant by the US FDA.

Lenire is available in more than 100 specialized clinics across the United States of America, Europe and the United Kingdom. Further details about Lenire® including a list of providers can be found at Lenire.com.

References and Notes

• 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)
• Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
• 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)
• US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/
• As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories. https://www.nidcd.nih.gov/health/tinnitus
• Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (20a23)

• Lenire, the first and only tinnitus treatment device of its kind approved by the FDA, is now an option for 2.9 million veterans living with tinnitus through Veterans Affairs.⁵
• Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government.
• The General Services Administration Federal Supply Schedule 65 II Medical Equipment and Supply Contract will also make Lenire an option for patients receiving care through the Department of Defense (DoD), the Bureau of Prisons, Indian Health Services, and Public Health Services.

Chicago, Illinois, June 17th, 2024: Neuromod USA Inc. has been awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making the Lenire tinnitus device a treatment option for the 2.9 million US Veterans living with tinnitus⁵ through the Department of Veterans Affairs (VA).

The General Services Administration FSS Contract will also make Lenire an option for patients receiving care from the Department of Defense (DoD), Bureau of Prisons, Indian Health Services, and Public Health Services.

Lenire is the first bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) Contract. It can be prescribed when appropriate by a trained healthcare clinician for the treatment of tinnitus.

General Services Administration’s decision to award the FSS contract was based on Neuromod Devices’ clinical trial success, commercial sales practices, financial performance, and additional clinical capability factors.

Tinnitus, which is commonly known as “ringing in the ears,” is a complex neurological condition afflicting an estimated ten percent of all adults.⁴ It causes a perception of sound when there is no external source. If left untreated, tinnitus severity can have a significant impact on a person’s quality of life.

Tinnitus has been the number one service-connected disability compensated for by the VA since 1955. More than 2.9 million veterans received more than $5 billion in compensation in 2023.⁵ Sixty-three percent of all auditory Veteran Compensation Claims were for tinnitus.⁵

“Tinnitus is the number one service-connected disability,” said Eric Timm, Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations.

“The number of veterans with tinnitus is growing at a double-digit rate annually. Neuromod’s FSS Contract ensures that current and future veterans have access to clinically proven tinnitus treatment technology. Everyone at Neuromod is privileged to be serving our veterans by doing our part for tinnitus care.”

Lenire’s bimodal neuromodulation works by pairing specially designed tones heard through wireless headphones with mild electrical pulses that stimulate the tongue through a component called the Tonguetip®.

In March 2023, Lenire became the first tinnitus treatment device to be awarded FDA Approval through the De Novo framework. FDA Approval was granted based on the success of Lenire’s controlled large-scale clinical trial, TENT-A3.

That trial confirmed Lenire was clinically superior to sound-only stimulation. 70.5% patients with moderate or worse tinnitus who did not report clinically significant improvement in their tinnitus from six weeks of sound-only, reported clinically significant tinnitus improvement following six weeks of treatment with Lenire.³

The majority of patients with moderate or worse tinnitus who benefitted from six weeks of sound-only stimulation experienced additional benefit from a further six weeks of treatment with Lenire.^{3, 6}

Nearly 89 percent of clinical trial participants would recommend Lenire to treat tinnitus.⁶

About Neuromod Devices

Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. Neuromod specialises in the design and development of neuromodulation technologies 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, where 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 shown to soothe and relieve tinnitus in large-scale clinical trials.^1,2,6

Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has 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 & Notes

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, https://www.nature.com/articles/s41598-022-13875-x (2022)
3. Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (2023)
4. https://www.nidcd.nih.gov/health/tinnitus
5. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/
6. TENT-A3 trial data in preparation for publication: https://clinicaltrials.gov/study/NCT05227365?intr=lenire&rank=1

DUBLIN, Ireland, June 03, 2024 — Neuromod Devices Ltd. (Neuromod), the global medical technology business that created the first and only FDA Approved tinnitus treatment device, Lenire, has today announced the appointment of Tom Maher as General Counsel, effective July 5, 2024.

Mr. Maher most recently served as Chief of Operations, Corporate Counsel and Company Secretary for Amarin Pharmaceuticals Ireland, and has a successful track record in three C-Suite positions for publicly traded companies.

“I am pleased to announce the appointment of Tom as Neuromod Devices’ General Counsel. Tom’s extensive background in international business and corporate operations in the life sciences industry will be an invaluable asset to Neuromod Devices as we continue to redefine tinnitus care on a global scale.” said Dr. Ross O’Neil, Neuromod Devices Founding CEO.

Tom Maher joins Neuromod Devices Ltd. with more than twenty-five years of corporate legal and business experience in the international life sciences industry, including biopharma, biotech, and medtech.

Tom Maher as General Counsel

In the role of General Counsel, Tom will be responsible for legal and contractual affairs, corporate transactions, governance, and corporate compliance for Neuromod.

Commenting on his appointment, Tom said: “I am excited to join the Neuromod leadership team as the company advances the commercialization of Lenire. I look forward to working with Ross and the broader team to drive the execution of Neuromod’s ambitious strategic plans in 2024 and beyond.”

Mr. Maher’s appointment comes as Neuromod continues to expand the global availability of Lenire. Earlier this year, the organisation increased the number of hearing and tinnitus care practices it partners with in the United States of America to more than 80. Neuromod also increased the availability of Lenire in Europe by establishing partnerships with additional practices in Spain, Italy, and the Principality of Monaco.

About Neuromod Devices

Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. Neuromod specializes in the design and development of neuromodulation technologies 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, where 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 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 and has 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.

Neuromod also increased the availability of Lenire in Europe by establishing partnerships with additional practices in Spain, Italy, and the Principality of Monaco.

Dublin, Ireland, January 23, 2024: Neuromod Devices Ltd., developer of the first and only FDA approved bimodal neuromodulation tinnitus treatment device, Lenire^®, has announced reorganisation of the company’s finance responsibilities within its Senior Management Team.

The reorganisation sees Chief Financial Officer, Derek Madden assume the role of Vice President of Finance and Corporate Governance. Neuromod’s current Chief of Strategy & Corporate Development, Florian Elsaesser, will succeed Mr. Madden as the company’s new Chief Financial Officer.

Neuromod was granted FDA approval for its first-of-a-kind tinnitus treatment device, Lenire, in 2023, which saw the technology company successfully launch in the United States of America resulting in exponential commercial growth.

The commercial growth combined with the company’s continuous expansion of US and European availability of Lenire, as well as an increase in corporate finance activity, prompted the organisation to ensure its financial organisation is best resourced and structured for continued growth. The reorganisation combines the strengths, skills, and experience of Mr. Elsaesser and Mr. Madden as Neuromod Devices enters a critical growth phase.

“The reorganisation ensures Mr. Elsaesser’s previous experience is fully utilised to deliver on our corporate development plans, which in turn, empowers Mr. Madden to focus his considerable expertise leading a medical device manufacturer on maintaining Neuromod’s financial operational excellence as we continue our global expansion.” – Dr. Ross O’Neill, Neuromod Devices Founding CEO.

Neuromod Finance Leadership Reorganisation

Florian Elsaesser gained extensive experience at a private equity-backed hearing instrument company as CFO of International Sales at Siemens Audiology Group, which was acquired from Siemens by EQT VI for €2.15bn. His appointment as Neuromod’s CFO allows the company to leverage his knowledge and provide dedicated resource to deliver on its strategic corporate development plan.

Derek Madden, Neuromod’s CFO for over a decade, has led the organisation through significant commercial growth and financing milestones including a €30 million Series B extension in 2023 which included the participation of the European Investment Bank.

Madden’s appointment as Vice President of Finance and Corporate Governance ensures that Neuromod will continue to support its commercial success in 2024 and beyond through the continued development of the financial operations required of a rapidly growing company.

Neuromod Devices’ bimodal neuromodulation tinnitus treatment device, Lenire, is the first device of its kind to receive FDA approval and CE-mark certification. Lenire has one of the largest evidence bases in existence for a tinnitus treatment device, having been proven safe and effective in three large-scale clinical trials that involved over 600 patients.^1,2,3

About Neuromod Devices

Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland and USA. Neuromod specialises in the design and development of neuromodulation technologies 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, where 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 granted approval by the US FDA after being 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 and has 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

• Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
• 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)
• TENT-A3 clinical trial data in preparation for publication. https://clinicaltrials.gov/ct2/show/NCT05227365