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• Equity investment led by Panakès Partners with venture debt provided by European Investment Bank
• Financing round follows recent US FDA granting of De Novo approval to Neuromod’s Lenire tinnitus treatment device

Dublin, Ireland, 13th April 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.

Tinnitus, commonly referred to as ‘ringing in the ears’, is the perception of sound without an external source and affects 10-15% of the global adult population¹. Lenire has shown in large scale clinical trials to reduce tinnitus severity.^2,3,4 The device has recently been granted De Novo approval from the US Food and Drug Administration (FDA) and is available throughout Europe.

As part of the overall financing, a €15m expansion of the Series B was led by Panakès Partners with participation from existing investor Fountain Healthcare Partners. An additional €15m in venture debt was provided by the European Investment Bank.

Proceeds from the financing will be used to launch Lenire in the USA and pursue opportunities in the US Departments of Defense and Veteran Affairs following the device’s recent FDA De Novo approval. The first US patients will start treatment for their tinnitus in April 2023.

Neuromod will also expand the availability of Lenire to additional European countries, including Italy, the Netherlands, Portugal, and Sweden, and further next generation product development.

Neuromod Closes €30 Million Financing

Since Neuromod’s previous round of funding in October 2020, the organisation has made significant progress commercialising Lenire, expanding the device’s availability throughout Europe, establishing a wholly owned US subsidiary, Neuromod USA Inc, and securing US market approval from the FDA.

Commenting on the news, Dr. Ross O’Neill, Founder & CEO of Neuromod said “We are delighted to announce the successful completion of our Series B2 financing and to welcome new investors Panakès and the European Investment Bank. Europe has a long history in leading the world in hearing innovation. We are proud to add to that tradition by bringing our landmark tinnitus treatment Lenire to the millions of sufferers in Europe and the USA. This investment will help us to expand availability of Lenire in Europe, launch the product in the US and pursue opportunities in the USVA and DoD following our recent De Novo grant from the FDA.”

“There are more people in the world with tinnitus than with hearing loss. Tinnitus is one of the largest unmet clinical needs globally and is the number one cause of service-connected disability among US veterans and military personnel. Despite this, there has been practically no innovation in the tinnitus area. This financial support will ensure that, once again, Europe leads the way as Neuromod addresses this huge unmet need in the hearing area.” Dr. O’Neill continued.

Thomas Östros, Vice President of the European Investment Bank, commented, “Tinnitus impacts the lives of millions of people and investment to develop new treatments is essential. The European Investment Bank supports cutting edge world class medtech companies and is pleased to provide €15 million venture debt financing to enable Neuromod to commercialise and expand access to tinnitus treatment technology.”

The management of tinnitus continues to pose a significant burden on healthcare systems. A recent study estimated the socioeconomic costs of tinnitus in Germany at €21.9 billion per annumvi. In the USA, tinnitus was the most prevalent service-connected disability compensated for by the US Veterans Benefits Administration with more than 2.7 million veterans compensated in 2022.⁷ It’s also estimated the Veterans Benefits Administration paid out more than $4.9 billion through its Veterans Compensation benefits program for tinnitus alone in 2022⁸.

Alessio Beverina, Managing Partner of Panakès, who will join Neuromod’s board, said, “Tinnitus remains a significant problem for patients around the world and an important cost for healthcare systems globally. Panakès is proud to support Neuromod’s continued work to meet this challenge with their ground-breaking product Lenire; I’m particularly excited at the possibility to improve the life of tinnitus patients and looking forward to working closely with Neuromod’s team.”

Dr. Manus Rogan, Chairman of Neuromod and Managing Partner of Fountain Healthcare Partners commented, “We’re proud to continue to support Neuromod as the organisation takes the next step forwards in their mission to improve quality of life for millions of people living with tinnitus. I’m delighted to welcome Alessio Beverina to Neuromod’s board at an exciting time for the company as they work towards making Lenire more widely available.”

What is Lenire?

Lenire is a bimodal neuromodulation device which works by delivering mild electrical pulses to the tongue, through an intra-oral component called the ‘Tonguetip^®’, combined with auditory stimulation through headphones to drive long-term changes in the brain to treat tinnitus. To date, the device has been used in large-scale clinical trials with over 700 patients.

The first of these trials, TENT-A1, represents one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field and was the cover story for the scientific journal Science Translational Medicine in October 2020. The trial enrolled 326 participants and 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptom severity after a 12-week treatment period.^3,4

In June 2022, the results of the second large-scale clinical trial, TENT-A2, were published in the highly-regarded journal Nature – Scientific Reports. TENT-A2 showed that changing the stimuli patients received after six weeks of treatment could result in a further clinically significant reduction in their tinnitus severity.^3,4

95% of treatment-compliant participants reported an improvement in their tinnitus symptom severity after 12 weeks of treatment[iii],[iv]. When followed up with 12 months after treatment had ended, 91% of treatment-compliant participants reported sustained improvement in their tinnitus severity.^3,4

A third large-scale clinical trial, TENT-A3, was designed to meet the FDA’s rigorous De Novo requirements and carried out from March to October 2022 at three independent sitesix. 70.5% of patients with moderate or worse tinnitus reported a clinically significant improvement in their tinnitus severity following six weeks of treatment with Lenire, after six weeks of sound-only treatment provided clinically insignificant improvement. Further results from the trial are currently in preparation for peer-review and publication in a scientific journal.

About Neuromod Devices Ltd

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. 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 a large-scale clinical trial. 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 grant of approval by the US FDA. Further details about Lenire including a list of providers can be found at www.lenire.com.

About Panakès Partners

Panakès Partners is a Venture Capital firm, based in Milan, which invests in the most ambitious companies and teams, developing revolutionary technologies and products, in the field of life sciences, aiming to improve the lives of people around the world. Panakès, founded in 2015 by Fabrizio Landi, Alessio Beverina and Diana Saraceni, has €250 million under management. www.panakes.it.

About Fountain Healthcare Partners

Fountain Healthcare Partners is a life science venture capital fund with offices in Dublin and New York. Founded in 2008, Fountain is Ireland’s largest dedicated life science venture capital fund with more than €300 million under management.
Fountain invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit and a defined pathway to commercialisation, value enhancement and exit. Fountain typically leads or co-leads its investments and has sourced private and public deals from start-ups, corporate spin-outs and turnaround situations. For more information please visit: www.fh-partners.com.

Connect with Neuromod

LinkedIn: linkedin.com/neuromod
Twitter: twitter.com/NeuromodDevices
Website: www.neuromod.com

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. As measured by THI. THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.
• 5. R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021), doi.org/10.1016/j.lanepe.2021.100250
• 6. 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.
• 7. US VA Benefits Report Fiscal Year 2022: benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf
• 8. According to va.gov/disability/compensation-rates/veteran-rates/past-rates-2022 the 2022 10% disability rate was $152.64 per month. 2,703,665 veterans benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf receiving 12 payments of $152.64 for tinnitus results in $4.952 billion. The VA assigns a 10% disability rating to tinnitus: benefits.com/veterans-disability/tinnitus-most-common-va-disability
• 9. clinicaltrials.gov/ct2/show/NCT05227365

• Neuromod Devices’ non-invasive device, Lenire, is the first of its kind granted approval to treat tinnitus in the US market.
• At least 25,000,000 Americans are suffering from tinnitus, 2,700,000 are veterans.
• FDA approval based on results of 112-patient pivotal TENT-A3 clinical trial supported by confirmatory Real-World Evidence from 204 patients.
• TENT-A3 primary endpoint analysis showed that patients at least moderately impacted by tinnitus¹ achieved a clinically meaningful improvement following the bimodal phase of the trial. This was consistent with what was observed in the Real-World Evidence submitted to the FDA.
• Over the entire trial, 79.4% of patients experienced a clinically significant improvement. 82.4% were compliant to bimodal treatment and 88.6% would recommend Lenire as a tinnitus treatment.
• When compared to sound therapy alone, patients at least moderately impacted by tinnitus_¹ were significantly more likely to achieve a clinically meaningful improvement using Lenire’s bimodal stimulation.
• Treatment with Lenire to be available for Americans with tinnitus from April 2023.

Chicago, Illinois, 7th March 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.

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 Americans² are currently suffering from tinnitus.

Tinnitus is a silent burden on the USA’s national healthcare system. The condition costs an estimated $660 per patient per year for visits to clinics alone³. Tinnitus is also the most prevalent and fastest-growing service-connected disability compensated for by The US Veterans Administration (VA). More than 2.7 million veterans were compensated in 2022⁴ and 12% year-on-year growth⁵. An estimated $4.9+ billion was paid through Veterans Affairs’ Compensation Benefits Program for tinnitus alone in 2022⁶ with further undisclosed expenditure on treatments, such as hearing aids, sound therapy and counselling, which deliver varying levels of success.

“Lenire’s approval not only means that millions of Americans living with tinnitus can get the treatment they need but further validates over a decade of research and development that resulted in a safe solution that provides relief for tinnitus patients. Lenire is the first bimodal neuromodulation device to go through the rigors of the FDA’s De Novo process. For patients that are at least moderately impacted by their tinnitus⁴, Lenire has now been shown to be more effective than sound therapy, which is one of the current clinical standards of treatment.” said Ross O’Neill, Neuromod Devices’ Founding CEO.

FDA Grants Lenire De Novo Approval Following TENT-A3 Clinical Trial

The FDA’s De Novo approval is based on the success of Lenire’s third large-scale clinical trial, TENT-A3. This was supported by Real-World Evidence from 204 patients. Over the entire trial, 79.4% of the patients experienced a clinically significant improvement. 82.4% were compliant to bimodal treatment. 88.6% responded that they would recommend Lenire as a tinnitus treatment⁷.

The TENT-A3 primary endpoint analysis showed that patients that were at least moderately bothered by tinnitus, including patients in the moderate, severe and catastrophic categories as defined by the Tinnitus Handicap Inventory (THI)¹, achieved a clinically meaningful improvement in tinnitus following the bimodal treatment phase of the trial.

The analysis showed that this patient group were more likely to achieve a clinically meaningful improvement using Lenire’s bimodal sound and tongue stimulation than sound therapy alone⁷. TENT-A3 also demonstrated that Lenire is inherently safe with zero serious adverse events⁷. These efficacy, compliance and safety findings were highly consistent with the Real-World Evidence from 204 patients included in the De Novo submission.

TENT-A3 Trial Design

TENT-A3 was a controlled clinical trial. The trial was designed by Neuromod to meet the FDA’s requirements, that compared the effects of 6 weeks of bimodal neuromodulation with 6 weeks of sound therapy alone. The trial was conducted at three independent sites from March to October 2022 with 112 enrolled participants⁸.

The De Novo approval of Lenire is significant. The approval acknowledges Lenire as a technological and clinical pioneer for tinnitus treatment. This approval establishes a new regulatory category for medical devices in the USA.

“With this FDA approval of the Lenire device, it will provide me and tinnitus specialists across the United States with an exciting new tinnitus treatment option for our clinical toolbox,” explained Dr. Jason Leyendecker (AuD). “Many tinnitus patients are not availing of currently available options, such as hearing aids and counseling, and success with these options is varied. What is especially encouraging about this new bimodal treatment is that it can deliver clinical benefits in as short as 6 weeks of treatment, which can greatly improve our capacity issues since more patients can be helped in a shorter period of time.” Dr. Leyendecker is a leading tinnitus specialist and owner of The Tinnitus and Hyperacusis Clinic of Minnesota. He is the past President of Minnesota Academy of Audiology and President Elect of Academy of Doctors of Audiology.

Neuromod’s Expansive Tinnitus Research

The TENT-A3 trial builds upon the success of two previous landmark clinical trials that included more than 500 patients.

TENT-A1

TENT-A1 was one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field.

The study was the cover story for the prestigious scientific journal Science – Translational Medicine in October 2020. TENT-A1 was a double-blind randomized trial involving 326 patients. These patients were evaluated over a 12-week treatment period and a 12-month post-treatment phase⁹.

86.2% of those who completed the 12 weeks of treatment reported improvement in their tinnitus severity⁹. These therapeutic improvements continued for 12 months after cessation of treatment. 83.7% of patients were treatment compliant and there were zero serious adverse events in the trial.⁹

TENT-A2

The results of Lenire’s second large-scale clinical trial, TENT-A2, were published in the highly regarded scientific journal Nature – Scientific Reports. TENT-A2 was a double-blind randomized trial involving 192-patients. TENT-A2 showed that changing stimuli midway through treatment enhanced the effectiveness of bimodal neuromodulation. 95% of patients that completed 12 weeks of treatment reported improvement in their tinnitus severity¹⁰. These therapeutic effects were sustained up to 12 months after treatment ended¹⁰. 83.8% of patients were treatment compliant and there were zero serious adverse events in the trial¹⁰.

“What is most remarkable is the consistency of the efficacy, safety and compliance data across our TENT-A1, TENT-A2 and TENT-A3 clinical trials. Taken together, we have demonstrated the effectiveness and inherent safety of Lenire in over 600 clinical trial patients. De Novo approval from the FDA is another significant achievement in what has been an exciting journey for our bimodal stimulation technology,” said Prof. Hubert Lim, Chief Scientific Officer at Neuromod Devices.

Lenire Availability

Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional. This includes an Audiologist or ENT Surgeon. After an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.

“FDA approval of the Lenire Tinnitus Treatment System is a quantum leap forward in the caring of patients with bothersome tinnitus. The otolaryngologist now has access to innovative Lenire technology and can prescribe it to patients who are at least moderately impacted by their tinnitus. The majority of these tinnitus patients are either inadequately relieved or are opting not to pursue existing options, such as hearing aids. These patients can now move forward with this impressive treatment system.” expressed Dr. Steven W. Cheung, Professor of Otolaryngology-Head and Neck Surgery at the University of California, San Francisco. Dr. Cheung is also Staff Otorhinolaryngologist at the Veterans Affairs San Francisco Healthcare System.

Driving Tinnitus Treatment Transformation

Neuromod Devices was founded by Dr. Ross O’Neill in 2010 to develop bimodal neuromodulation technologies for tinnitus. Neuromod is supported by venture capital firms Fountain Healthcare Partners and Panakes Partners. In 2021, Neuromod established Neuromod USA Inc. as a wholly owned subsidiary. This was to prepare for the market entry of Lenire in the USA pending FDA approval.

Since then, Neuromod USA has convened a clinical advisory board of specialist tinnitus clinicians from across the US. These clinical experts will advise on and ensure that patients who will use Lenire receive unrivalled care throughout their treatment.

Following the FDA’s granting of approval, Neuromod will train Audiologists and ENT Surgeons specialising in tinnitus care with the intention of treating the first tinnitus patients based in the USA as soon as April 2023.

References & Notes

• [1] 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.
• [2] nidcd.nih.gov/health/tinnitus
• [3] Goldstein E., Ho C.X., Hanna R., Elinger C., Yaremchuk K.L., Seidman M.D., Jesse M.T. Cost of care for subjective tinnitus in relation to patient satisfaction. Otolaryngol. Head Neck Surg. 2015;152:518–523. doi: 10.1177/0194599814566179.
• [4] US VA Benefits Report Fiscal Year 2022: benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf
• [5] Calculated based on average annual increase in tinnitus benefit recipients from 2008 to 2022: benefits.va.gov/REPORTS/abr/archive.asp
• [6] According to https://www.va.gov/disability/compensation-rates/veteran-rates/past-rates-2022/ the 2022 10% disability rate was $152.64 per month. 2,703,665 veterans benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf receiving 12 payments of $152.64 for tinnitus results in $4.952 billion. The VA assigns a 10% disability rating to tinnitus: benefits.com/veterans-disability/tinnitus-most-common-va-disability
• [7] TENT-A3 clinical trial data in preparation for publication
• [8] clinicaltrials.gov/ct2/show/NCT05227365
• [9] Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
• [10] 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

About Neuromod Devices Ltd

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of bimodal neuromodulation technologies. These technologies to address the clinical needs of patients suffering from chronic and debilitating tinnitus. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe. Lenire also has received a granting of De Novo approval from the FDA in the USA. For more information visit neuromoddevices.com.

About Lenire

Lenire is a combined acoustic and electrical intraoral stimulation device for the relief of tinnitus. The device’s novel bimodal neuromodulation technology includes three parts. Bluetooth® headphones, which play custom sounds to the ear to activate the auditory nerve. A Tonguetip®, which is a proprietary intraoral device that also activates nerves by sending mild electrical stimulation to the surface of the tongue. A Controller that allows patients to adjust the duration and treatment intensity.

The custom sounds and tongue stimulation work together to reduce patients’ tinnitus severity. It is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to relieve tinnitus in three large-scale clinical trials.

Lenire has been granted De Novo approval for the treatment of tinnitus in the USA by the FDA. Lenire is CE-marked in Europe. Further details about Lenire including a list of providers can be found at lenire.com.

Connect with Neuromod Devices Ltd

LinkedIn: linkedin.com/company/neuromod
Twitter: twitter.com/NeuromodDevices
Website: neuromoddevices.com

• More than 1 million Hungarians are living with tinnitus.
• Tinnitus Klinika’s 3 clinics will provide Lenire throughout Hungary
• Availability in Hungary follows publication of second large-scale clinical trial results, showing greater improvement in tinnitus symptoms.

Budapest, Hungary, 29th September 2022: Irish medical device company, Neuromod Devices Ltd., which specialises in the treatment of tinnitus, has reached an agreement with Tinnitus Klinika kft, a provider of specialist tinnitus care, to make its Lenire device available in Hungary.

Lenire is a bimodal neuromodulation device which has shown in analysis of real-world patients and multiple large-scale clinical trials to reduce the severity of tinnitus symptoms. Tinnitus, commonly known as “ringing in the ears”, is a complex neurological condition resulting in the perception of sound without an external source.

Landmark research into the prevalence of tinnitus in Europe was published in renowned scientific journal, The Lancet, in late 2021. It found that prevalence of any tinnitus was 14.7%² which could mean that 1.4 million Hungarians experience the condition.

Lenire Now Available in Hungary

Through this distribution agreement, Tinnitus Klinika’s specialist team has exclusive licence from Neuromod to provide Lenire throughout Hungary to suitable patients for the treatment of their tinnitus.

“I’m delighted to work with Tinnitus Klinika to make Lenire available to people living with tinnitus in Hungary. Tinnitus is globally recognised as a significant healthcare challenge and many people living with the condition have unmet clinical needs. Tinnitus specialists like Tinnitus Klinika deeply understand the needs of tinnitus patients and we’re proud to be able to support them in improving therapeutic outcomes for their patients,” explains Dr Ross O’Neill, Founder and CEO of Neuromod Devices.

In the last 12 months Neuromod has expanded availability of Lenire in Europe, launching it in Denmark, Norway, Spain, Switzerland, and the UK. Earlier in 2022 the results of an independent real-world analysis were published in the peer-reviewed scientific journal, Brain Stimulation, demonstrating the safety and efficacy of the Lenire device for improving symptoms in tinnitus patients. The study found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms, as measured by THI[ii], following six to 12 weeks of treatment using Lenire³.

Lenire Clinical Trials

The device has also been used in large-scale clinical trials with over 500 patients. In June, the results of Lenire’s second large-scale clinical trial were published in the highly regarded scientific journal, Nature – Scientific Reports. They showed a significant further breakthrough for improving tinnitus symptoms severity with Lenire[iv].

By changing the stimuli patients received halfway through their treatment plan, a clinically significant greater average improvement in tinnitus symptom severity was demonstratediv. 95% of treatment-compliant participants reported an improvement in their tinnitus symptoms, as measured by THI[ii],[iv]. 91% of treatment-compliant participants reported an improvement which sustained at least up to 12 months after treatment had ended[iv].

Tinnitus Klinika’s team have been providing specialist care for people living with tinnitus since it was founded in 2008 by Tamás Nagy, who holds a degree in Audiology from Oxford-Brookes University. The organisation operates 3 clinics in Hungary at Czeizel Institute in Budapest, Hallomás Center in Veszprém, and at Debrecen University in partnership with the University’s Medical school. Tinnitus Klinika offers a suite of therapeutic interventions for people with tinnitus, which now includes Lenire, and has facilitated research of these interventions in their clinical practices under the guidance of the organisation’s Advisory Board.

“Tinnitus Klinika’s partnership with Neuromod is a significant step forward for our tinnitus patients. I’m delighted to be able to provide an evidence-based treatment option that has seen encouraging patient outcomes in large-scale clinical trials and in the real world as part our suite of services for people living with the condition. I’m looking forward to working closely with Neuromod’s team to achieve the best possible patient outcomes in our clinics,” explains Tamás Nagy, CEO at Tinnitus Klinika.

What is Lenire?

Lenire is a bimodal neuromodulation device which combines mild electrical pulses to the tongue with sound stimulation to drive neuroplasticity in the brain which reduces the symptoms of tinnitus. It has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional and is currently available throughout Europe.

The device consists of Bluetooth® headphones which play customised sounds to activate the auditory nerve, a proprietary intra-oral device which provides mild electrical stimulation to the surface of the tongue, known as a Tonguetip®, and a controller which controls the duration and intensity of treatment with the device.

The device’s sound and electrical stimuli can be calibrated to suit a patient’s tinnitus after an initial assessment of their condition which includes an audiological exam. The supervising healthcare professional demonstrates how to use the device and provides the patient with instructions for use. Subsequently, patients use Lenire for 60 minutes per day typically for at least 10 weeks. Follow-up visits with the healthcare professional occur during treatment to monitor patients’ progress.

At the end of the prescribed treatment plan, the healthcare professional advises the patient about their continued use of Lenire.

About Neuromod

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of bimodal neuromodulation technologies to address the clinical needs of patients suffering from chronic and debilitating tinnitus. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe and has received a granting of De Novo approval from the FDA in the USA. For more information visit neuromoddevices.com.

About Lenire

Lenire is a combined acoustic and electrical intraoral stimulation device for the relief of tinnitus. The device’s novel bimodal neuromodulation technology includes three parts. Bluetooth® headphones, which play custom sounds to the ear to activate the auditory nerve, a Tonguetip®, which is a proprietary intraoral device that also activates nerves by sending mild electrical stimulation to the surface of the tongue, and a controller that allows patients to adjust the duration and treatment intensity.

The custom sounds and tongue stimulation work together to reduce patients’ tinnitus severity. It is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to relieve tinnitus in three large-scale clinical trials.

Lenire has been granted De Novo approval for the treatment of tinnitus in the USA by the FDA and CE-mark certification in Europe. Further details about Lenire including a list of providers can be found at lenire.com.

Connect with Neuromod Devices Ltd

LinkedIn: linkedin.com/company/neuromod
Twitter: twitter.com/NeuromodDevices
Website: neuromoddevices.com

References

[i] 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  

[ii] THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.

[iii] Buechner A, Lesinski-Schiedat A, Becker P, Lenarz T, Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus – A case series, Brain Stimulation (2022), doi: https://doi.org/10.1016/j.brs.2022.01.022.

[iv] Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://doi.org/10.1038/s41598-022-13875-x (2022)

• Specialklinikken Borgå to host a series of tinnitus seminars throughout Denmark after exclusive distribution deal.
• Lenire’s availability in Denmark follows publication of second large-scale clinical trial results, showing greater improvement in tinnitus symptoms.

Irish medical device company, Neuromod Devices Ltd., which specialises in the treatment of tinnitus has reached an agreement with Specialklinikken Borgå ApS, Denmark’s longest established provider of private care for tinnitus, to make its Lenire device available in Denmark.

Lenire is a bimodal neuromodulation device which has shown in clinical trials to reduce the symptoms of tinnitus. Tinnitus, commonly known as “ringing in the ears”, is a complex neurological condition resulting in the perception of sound without an external source. It’s thought to affect 10-15% of the adult population globally[1].

Landmark research into the prevalence of tinnitus in Europe was published in renowned scientific journal, The Lancet, in late 2021. It found that prevalence significantly increased with increasing age and worsening of hearing status. It also found that healthcare resource use for tinnitus increased with increasing tinnitus symptom severity[2]. These findings were consistent with The Danish National Health Authority’s 2017 National Health Report which found the prevalence of tinnitus in the country to be 12.7%, a 25% increase from 10.1% in 2010, and that prevalence increased with increasing age[3].

Through this distribution agreement, Specialklinikken Borgå’s specialist team has exclusive licence from Neuromod to provide Lenire, throughout Denmark, to suitable patients for the treatment of their tinnitus.

“I’m proud that by working with Specialklinikken Borgå we can make Lenire available to people living with tinnitus in Denmark. Tinnitus is globally recognised as a significant healthcare challenge and many people living with the condition have unmet clinical needs. By partnering with tinnitus specialists like Specialklinikken Borgå we’re aiming to improve therapeutic outcomes for these people,” explains Dr Ross O’Neill, Founder and CEO of Neuromod Devices.

The agreement comes following Lenire’s launches in Norway and Spain earlier in 2022 and the publication of an independent real-world study demonstrating the safety and efficacy of the Lenire device for improving symptoms in tinnitus patients. The study found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms, as measured by THI[4], following six to 12 weeks of treatment using Lenire[5]. The results were recently published in the highly ranked scientific journal, Brain Stimulation.

The device has also been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the internationally renowned journal Science Translational Medicine and reported improvements in patients’ tinnitus symptoms. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms, measured by THI, after a 12-week treatment periodvi. When followed up with 12 months post treatment, 80.1% of treatment-compliant participants had sustained the improvements[6]. This study represents one of the largest and longest followed-up clinical trials ever conducted in the field of tinnitus devices.

In June 2022, the results of a second large-scale clinical trial of Lenire were published in Nature – Scientific Reports reporting greater average improvement in tinnitus symptoms than the first trial due to optimised treatment plans for participants[7]. 95% of treatment-compliant participants reported an improvement in their tinnitus symptoms[7].

Tinnitus Seminars Roadshow

To coincide with the introduction of Lenire to the Danish market, Specialklinikken Borgå ApS is hosting a roadshow of tinnitus seminars throughout Denmark for people living with tinnitus. The roadshow begins in Aarhus with further events in Middlefart, Skive, Odense, Copenhagen, Aalborg, and Esbjerg throughout July and August. Further details about each seminar and tickets are available at https://borgaa.com/.

“I’m delighted that Specialklinikken Borgå are partnering with Neuromod so we can provide an evidence-based treatment option that has seen encouraging patient outcomes in large-scale clinical trials and in the real world. I’m especially looking forward to our roadshow of tinnitus seminars to provide people with tinnitus an opportunity to discuss the breakthrough Lenire treatment,” explains Thomas Borgå, CEO at Specialklinikken Borgå.

Lenire is a bimodal neuromodulation device which combines mild electrical pulses to the tongue with sound stimulation to drive neuroplasticity in the brain which reduces the symptoms of tinnitus. It has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional and is currently available throughout Europe.

The device consists of Bluetooth® headphones which play customised sounds to activate the auditory nerve, a proprietary intra-oral device which provides mild electrical stimulation to the surface of the tongue, known as a Tonguetip®, and a controller which controls the duration and intensity of treatment with the device.

The device’s sound and electrical stimuli can be calibrated to suit a patient’s tinnitus after an initial assessment of their condition which includes an audiological exam. The supervising healthcare professional demonstrates how to use the device and provides the patient with instructions for use. Subsequently, patients use Lenire for 60 minutes per day typically for at least 10 weeks. Follow-up visits with the healthcare professional occur during treatment to monitor patients’ progress.

At the end of the prescribed treatment plan, the healthcare professional advises the patient about their continued use of Lenire.

About Specialklinikken Borgå ApS

Specialklinikken Borgå, founded in 2001, is Denmark’s longest established treatment centre for private tinnitus care. The centre is based in Skive, offers in-patient and telehealth services, and provides a number of treatment interventions across a range of health conditions.

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

References

[1] Baguely et al., Tinnitus, The Lancet (2013), https://www.sciencedirect.com/science/article/pii/S0140673613601427

[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] Danskernes Sundhed – Den Nationale Sundhedsprofil, Danish Health Authority, www.sst.dk

[4] THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.

[5] Buechner A, Lesinski-Schiedat A, Becker P, Lenarz T, Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus – A case series, Brain Stimulation (2022), doi: https://doi.org/10.1016/j.brs.2022.01.022.

[6] Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

[7] Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://doi.org/10.1038/s41598-022-13875-x (2022)

• Second large-scale trial shows greater reduction in tinnitus symptom severity using bimodal neuromodulation device, Lenire
• 91% of treatment compliant participants experienced improvement in tinnitus symptoms that sustained 12 months after treatment
• 87.8% said they would recommend treatment to others with tinnitus

Dublin, Ireland, June 30 2022 – Neuromod Devices Limited, the Irish medical device company specialising in the treatment of tinnitus, 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 – Scientific Reports in a paper titled: ‘Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial’.

The full paper is available here: TENT-A2 results[1].

Tinnitus, commonly referred to as ‘ringing in the ears’ is thought to affect between 10 – 15% of the global adult population[2,3]. The TENT-A2 trial, which included 191 participants, is the company’s second large-scale clinical trial and sought to replicate and further enhance the results demonstrated in the company’s TENT-A1 trial, a study that evaluated the safety and efficacy of Lenire®, the company’s non-invasive bimodal neuromodulation device in 326 participants.

The publication of the TENT-A2 results in Nature – Scientific Reports follows on from the publication of the TENT-A1 results as the cover story in Science – Translational Medicine in 2020 (the full TENT-A1 results paper is available here: TENT-A1 results)[4]. This second major publication continues Neuromod’s strategy to establish the clinical credibility of bimodal neuromodulation through publishing large-scale clinical trials in top-tier peer-reviewed journals.

The TENT-A2 study investigated if changing treatment stimuli after six weeks of treatment would result in greater improvement in tinnitus symptoms than observed in the TENT-A1 study, during which participants were treated with the same stimuli for the entire 12-week treatment period.

In the TENT-A1 study, treatment compliant participants demonstrated a mean improvement that was more than twice the published clinically important improvement. In the TENT-A2 study, 95% of treatment compliant participants achieved a greater average improvement in symptoms compared to TENT-A1[1,4,5] and almost three times the published clinically important improvement. 91% of treatment compliant participants achieved an improvement that sustained 12 months after treatment concluded[1,5].

TENT-A2 is the second large-scale clinical trial validating the safety, with high patient satisfaction and tolerability, of bimodal neuromodulation as a treatment for tinnitus while also demonstrating greater efficacy in reducing tinnitus symptoms through optimised treatment regimens compared to the first large-scale trial.

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 and available commercially throughout Europe, was developed by Neuromod. 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. Before using the treatment for the first time, the device is configured to the patient’s hearing profile and optimised to the patient’s sensitivity level for tongue stimulation.

Similarly to TENT-A1, participants in the TENT-A2 trial were instructed to use Lenire for 60 minutes each day for 12 weeks. However, after an initial six weeks of treatment, the timing and delivery of the audio and tongue stimuli were changed for participants of the TENT-A2 trial for their remaining six weeks of treatment. In TENT-A1, the stimulation setting remained the same for the full 12 weeks of treatment. This change in treatment regimen resulted in a greater average reduction in tinnitus symptom severity achieved by treatment compliant participants[1,4,5].

The study was conducted at the Wellcome Trust-HRB Clinical Research Facility, St. James’s Hospital, Dublin, Ireland with no treatment-related Serious Adverse Events (SAEs) reported and a high treatment compliance. Out of 191 enrolled participants, 83.8% used the device at or above the minimum compliance level over the 12-week treatment period[1].

When treatment was completed, participants returned their devices and were assessed at three follow-up appointments up to 12 months. 70.3% of the 172 participants who filled out the exit survey said they had benefited from using the treatment and 87.8% said they would recommend other people with tinnitus to try the treatment[1].

Participants were screened and selected based on a pre-defined list of inclusion and exclusion criteria that enrolled a representative sample of the wider tinnitus population. Further information about the criteria can be found using identifier NCT03530306 at clinicaltrials.gov.

Speaking on the news, Dr Ross O’Neill, Founding CEO of Neuromod said, “We’re delighted to announce the publication of positive results from the TENT-A2 clinical trial which show greater improvement in tinnitus symptoms from treatment with Lenire. Tinnitus remains one of the largest unmet clinical needs globally and I’m proud that Neuromod is at the forefront of developing bimodal neuromodulation technology to treat chronic tinnitus. Publishing two large-scale clinical trials in internationally-recognised peer-reviewed journals with positive results for a tinnitus treatment device is a historic milestone, and we’re committed to continuing our research in this area to further improve patient outcomes”.

Hubert Lim, Chief Scientific Officer at Neuromod, commented, “I am proud of our company’s ability to build on our prior research by enrolling 191 participants in another large-scale clinical trial that showed even greater improvements in tinnitus symptoms compared to our previous large-scale study when adjusting the stimulation regimen over time. The successful completion of two large-scale trials is a major milestone in our continuing work to develop a treatment to help as many people living with tinnitus and in further demonstrating bimodal neuromodulation as a safe and effective intervention for people living with the condition”.

ENDS

For more information please contact: 
Neil Doyle 
Global Director of Marketing 
Neuromod Devices 
neil.doyle@neuromoddevices.com 

 
About Neuromod Devices Ltd 
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. 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. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe. 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 a large-scale clinical trial4. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details about Lenire including a list of providers can be found at www.lenire.com.

About Nature – Scientific Reports
Scientific Reports is an open access journal publishing original research from across all areas of the natural sciences, psychology, medicine and engineering and a member of the Nature family of research journals. Scientific Reports is the 6th most-cited journal in the world, with more than 540,000 citations in 20206, and receives widespread attention in policy documents and the media.

Connect with Neuromod Devices Ltd 
LinkedIn: linkedin.com/company/neuromod
Twitter: twitter.com/NeuromodDevices
Neuromod Devices website: neuromoddevices.com
Lenire website: lenire.com

References
[1] 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)
[2] Baguely et al., Tinnitus, The Lancet (2013), https://www.sciencedirect.com/science/article/pii/S0140673613601427
[3] McCormack, A., Edmondson-Jones, M., Somerset, S. & Hall, D. A systematic review of the reporting of tinnitus prevalence and severity. Hear Res. 337, 70–79. https://doi.org/10.1016/j.heares.2016.05.009 (2016).
[4] Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
[5] As measured by Tinnitus Handicap Inventory (THI)
[6] 2020 Journal Citation Reports® Science Edition (Clarivate Analytics, 2021)

Oslo, Norway, 20th May 2022: Irish medical device company, Neuromod Devices Ltd., which specialises in the treatment of tinnitus has reached an agreement with HØR AS, Norway’s largest private provider of hearing and tinnitus care, to make its Lenire tinnitus treatment device available in Norway.

Lenire is a bimodal neuromodulation device which has shown in clinical trials to reduce the symptoms of tinnitus. Tinnitus, commonly known as “ringing in the ears”, is a complex neurological condition resulting in the perception of sound without an external source. It’s thought to affect 10-15% of the adult population globally(i) which could mean up to 650,000 Norwegians are living with the condition.

Landmark research into the prevalence of tinnitus in Europe was published in renowned scientific journal, The Lancet, in late 2021. It found that prevalence significantly increased with increasing age and worsening of hearing status. It also found that healthcare resource use for tinnitus increased with increasing tinnitus symptom severity(ii).

Through this agreement, HØR’s specialist audiology team has licence from Neuromod to provide Lenire for the treatment of tinnitus to suitable patients in their chain of private clinics throughout Norway. HØR’s flagship clinic is at Ullevål Stadion, with an additional inhouse clinic at Aleris Frogner. The organisation is expanding with two more clinics in Trondheim and Vestfold opening in the coming months.

“I’m delighted that by working with HØR we can make Lenire available to people living with tinnitus in Norway. Tinnitus remains a significant healthcare challenge but by partnering with clinical specialists like the team at HØR we can improve patient outcomes for people living with the condition,” explains Dr Ross O’Neill, Founder and CEO of Neuromod Devices.

The agreement comes following Lenire’s launch in Spain in early 2022 and the publication of an independent real-world study demonstrating the safety and efficacy of the Lenire device for improving symptoms in tinnitus patients. The study found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms, as measured by THI(iii), following six to 12 weeks of treatment using Lenire(iv). The results were recently published in the highly ranked scientific journal, Brain Stimulation.

The device has also been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the internationally renowned journal Science Translational Medicine and reported improvements in patients’ tinnitus symptoms. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms, measured by THI, after a 12-week treatment period(v). When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements(v). This study represents one of the largest and longest followed-up clinical trials ever conducted in the field of tinnitus devices.

“I’m delighted that HØR are partnering with Lenire so we can provide an evidence-based treatment option that has seen encouraging patient outcomes in large-scale clinical trials and in the real world. I’m looking forward to working with Neuromod closely as we open our new clinics in Trondheim and Vestfold so we can provide care to more people who are living with tinnitus,” explains Janne Hallset Mykkelbost, CEO at HØR.

Lenire is a bimodal neuromodulation device which combines mild electrical pulses to the tongue with sound stimulation to drive neuroplasticity in the brain which reduces the symptoms of tinnitus. It has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe.

The device consists of Bluetooth® headphones which play customised sounds to activate the auditory nerve, a proprietary intra-oral device which provides mild electrical stimulation to the surface of the tongue, known as a Tonguetip®, and a controller which controls the duration and intensity of treatment with the device.

The device’s sound and electrical stimuli can be calibrated to suit a patient’s tinnitus after an initial assessment of their condition which includes an audiological exam. The supervising healthcare professional demonstrates how to use the device and provides the patient with instructions for use. Subsequently, patients use Lenire for 60 minutes per day typically for at least 10 weeks. Follow-up visits with the healthcare professional occur during treatment to monitor patients’ progress.
At the end of the prescribed treatment plan, the healthcare professional advises the patient about their continued use of Lenire.

ENDS

For more information please contact:
Neil Doyle
Global Director of Marketing,
Neuromod Devices
neil.doyle@neuromoddevices.com

Notes to Editor:

About Neuromod Devices Ltd
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. 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. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe. For more information visit www.neuromoddevices.com.

About HØR
HØR is Norway’s largest private treatment centre for hearing healthcare and tinnitus. Founded in 2017, HØR’s team of audiological specialists provide care for hearing, hearing aids, tinnitus, reduced sound tolerance and moulded earplugs. The organisation has two private clinics in Norway with a further two clinics opening in 2022.

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

References
(i) Baguely et al., Tinnitus, The Lancet (2013), https://www.sciencedirect.com/science/article/pii/S0140673613601427

(ii) 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

(iii) THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.

(iv) Buechner A, Lesinski-Schiedat A, Becker P, Lenarz T, Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus – A case series, Brain Stimulation (2022), doi: https://doi.org/10.1016/j.brs.2022.01.022.

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

• Cross-functional team will further support key clinical partners providing Lenire®.
• Eric Timm appointed President, Global Commercial Operations.
• Florian Elsaesser appointed Chief Strategy and Corporate Development Officer.

Dublin, Ireland, April 6th 2022: Neuromod Devices Ltd. has announced the formation of a global commercial leadership team to direct the commercialisation of its Lenire tinnitus treatment device through key partnerships.

The establishment of the team sees the organisation’s U.S. leadership executives Tish Ramirez, Holly Dean, and Stephanie Glowacki join its existing commercial leadership to establish a cross-functional group with significant sales, marketing, finance, and clinical experience in the hearing healthcare industry. The cross-functional team’s strategy will support existing clinical partners to continue achieving successful treatment outcomes through further clinical and commercial initiatives while partnering with key specialist clinicians to introduce Lenire in new markets.

In addition to his role as CEO of Neuromod USA Inc., Neuromod’s wholly owned U.S. subsidiary, Eric Timm has been appointed President, Global Commercial Operations to head the newly formed team with global responsibility for the organisation’s commercial strategy.

“Since bringing Lenire to market we’ve achieved significant success by expanding its availability across Europe. Building on that success I am delighted to announce the formation of our global commercial leadership team to further support our healthcare partners in achieving positive outcomes for their tinnitus patients and introduce Lenire to new markets through key partnerships”, says Ross O’Neill, Founder and CEO, Neuromod Devices Ltd.

Mr. Timm has more than 35 years’ experience holding leadership positions in medical devices and hearing aid companies. He joined Neuromod as CEO of Neuromod USA in 2021 from WS Audiology, one of the biggest hearing aid manufacturers in the world, where he was President and Chief Executive Officer of the company’s U.S. wholesale business.

Before that, he was CEO of Sivantos USA when it merged with Widex to become WS Audiology. He had previously been Chief Operating Officer of Sivantos USA. In addition, Eric has held general management, sales, marketing, and corporate strategy leadership positions at Phonak, Cardinal Health, Bristol-Myers Squibb and 3M.

“Since joining Neuromod I have seen first-hand the tremendous outcomes tinnitus patients have achieved using Lenire and I’m looking forward to working with our commercial team to make that a reality for more people living with the condition”, says Eric Timm, President, Global Commercial Operations and CEO, Neuromod USA.

The announcement comes following the launch of Lenire into the Spanish market in March as Neuromod continues to expand availability of the device throughout Europe. Earlier in the year the organisation launched Ótologie, its clinical service dedicated to tinnitus care.

Florian Elsaesser has been appointed Chief Strategy and Corporate Development Officer, assuming responsibility for the execution of Neuromod’s corporate strategy agenda.

Prior to joining Neuromod in 2020, Mr. Elsaesser held various executive positions for Sivantos and Siemens Audiology. Prior to Siemens Audiology’s acquisition by Private Equity fund EQT, Florian held senior financial roles managing global functions in finance and controlling. After the acquisition, Florian went on to hold senior business development and marketing roles in the newly rebranded Sivantos. In these roles, he managed the acquisition and integration of companies and coordinated global sales and marketing functions.

“Florian has been instrumental in our success so far to bring Lenire to as many people with tinnitus as possible and holds critical experience in corporate development that he will bring to our strategic ambitions. I’m delighted to be working with him closely as we look to further support underserved patient populations through our planned corporate agenda”, says Ross O’Neill.

“I’m looking forward to working with our dedicated global teams to progress our corporate development agenda to further support patient populations through best-in-class treatment interventions”, says Florian Elsaesser, Chief Strategy and Corporate Development Officer.

Lenire is a bimodal neuromodulation device which has shown in large-scale clinical trials to reduce the symptoms of tinnitus by combining mild electrical pulses to the tongue with sound stimulation(i). It’s currently available in eight countries in Europe through prescription by qualified healthcare professionals.

ENDS

For more information please contact:
Neil Doyle
Global Director of Marketing,
Neuromod Devices
neil.doyle@neuromoddevices.com

About Neuromod Devices Ltd
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. 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. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe. 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 a large-scale clinical triali. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details about Lenire including a list of providers can be found at www.lenire.com.

Connect with Neuromod Devices Ltd
LinkedIn: linkedin.com/company/neuromod
Twitter: twitter.com/NeuromodDevices
Website: neuromoddevices.com

References

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

• Lenire stimulates the brain to reduce the symptoms of tinnitus

• Neuromod agrees exclusive distribution deal with TRUSBIN to make Lenire initially available in Barcelona

• Renowned otorhinolaryngologist Dr Jordi Coromina, practicing at Teknon Clinic in Barcelona, will prescribe and supervise treatment of tinnitus patients with the Lenire device.

Barcelona, Spain, 29th March 2022: Irish medical device company, Neuromod Devices Ltd., which specialises in the treatment of tinnitus has reached a distribution agreement with TRUSBIN to make its Lenire tinnitus treatment device available in Spain.

Lenire is a bimodal neuromodulation device which has shown in clinical trials to reduce the symptoms of tinnitus. Tinnitus, commonly known as “ringing in the ears”, is a complex neurological condition resulting in the perception of sound without an external source. It’s thought to affect 10-15% of the adult population globally(i).

Through this agreement, TRUSBIN’s multidisciplinary team has licence from Neuromod and necessary training to distribute Lenire in Spain. Initially Lenire will be available in Barcelona with plans to expand availability of the device.

TRUSBIN have reached an agreement with the renowned otorhinolaryngologist Dr Jordi Coromina of the Teknon Clinic in Barcelona to be the first clinician in Spain providing treatment with the device.

“I’m delighted that by working with TRUSBIN we can make Lenire available to people living with tinnitus in Spain. We consider Barcelona to be an ideal starting point due to its tradition in the medical field and its concentration of clinical expertise and we’re looking forward to continually expanding the availability of Lenire throughout the country,” explains Dr Ross O’Neill, Founder and CEO of Neuromod Devices.

The agreement comes following the publication of an independent real-world study demonstrating the safety and efficacy of the Lenire device for improving symptoms in tinnitus patients. The study found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms, as measured by THI(ii), following six to 12 weeks of treatment using Lenire(iii). The results were recently published in the highly ranked scientific journal, Brain Stimulation.

The device has also been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the internationally renowned journal Science Translational Medicine and reported improvements in patients’ tinnitus symptoms. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms, measured by THI, after a 12-week treatment period(iv). When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements(iv). This study represents one of the largest and longest followed-up clinical trials ever conducted in the field of tinnitus devices.

“After suffering from tinnitus for years and trying different treatments with unsuccessful results, I discovered Lenire. The treatment was such a resounding success that it encouraged me to bring it to Spain through TRUSBIN, which has a medical and multidisciplinary team suitable to offering the treatment,” explains Xavier Cirera, founder of TRUSBIN.

Lenire is a bimodal neuromodulation device which combines mild electrical pulses to the tongue with sound stimulation to drive neuroplasticity in the brain which reduces the symptoms of tinnitus. It has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe.

The device consists of Bluetooth® headphones which play customised sounds to activate the auditory nerve, a proprietary intra-oral device which provides mild electrical stimulation to the surface of the tongue, known as a TongueTip®, and a controller which controls the duration and intensity of treatment with the device.

The device’s sound and electrical stimuli can be calibrated to suit a patient’s tinnitus after an initial assessment of their condition which includes an audiological exam. The supervising healthcare professional demonstrates how to use the device and provides the patient with instructions for use. Subsequently, patients use Lenire for 60 minutes per day typically for at least 10 weeks. Follow-up visits with the healthcare professional occur during treatment to monitor patients’ progress.

At the end of the prescribed treatment plan, the healthcare professional advises the patient about their continued use of Lenire.

ENDS

About Neuromod Devices Ltd
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. 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. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe. For more information visit www.neuromoddevices.com.

About Trusbin
TRUSBIN is a medical distribution company made up of a multidisciplinary team of commercial and medical professionals. The organisation is Neuromod’s partner in Spain, holding a licence to distribute the Lenire device.

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

References
(i) Baguely et al., Tinnitus, The Lancet (2013), sciencedirect.com/science/article/pii/S0140673613601427

(ii) THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.

(iii) Buechner A, Lesinski-Schiedat A, Becker P, Lenarz T, Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus – A case series, Brain Stimulation (2022), doi: doi.org/10.1016/j.brs.2022.01.022.

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

Irish medical device company, Neuromod Devices Ltd. (Neuromod), has welcomed the findings of an independent study performed at the German Hearing Center (DHZ) at Hannover Medical School, which found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms (based on the Tinnitus Handicap Inventory(i) score across 20 patients) when using the Lenire treatment device.

This study showed that six to 12 weeks of treatment using Lenire, a bimodal neuromodulation device developed by Neuromod that provides sound and electrical stimulation of the tongue, can safely achieve clinically meaningful improvements in tinnitus symptom severity in a real-world clinical setting.

The study was led by Drs. Thomas Lenarz, Anke Lesinski-Schiedat, and Andreas Buechner from the Department of Otolaryngology at the Hannover Medical School, Germany.

These results were (link: https://www.brainstimjrnl.com/article/S1935-861X(2200028-6/fulltext text: recently published in the highly ranked scientific journal, Brain Stimulation)(ii).

The real-world data are consistent with the outcomes of Neuromod’s large-scale clinical trial (TENT-A1), which included 326 participants. The TENT-A1 trial, the results of which were published in October 2020(iii), showed that 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week period using Lenire.

The Hannover study involved shorter durations of treatment (6-12 weeks) and observed a mean improvement (reduction) in THI score of 10.4 points, which exceeds the clinically meaningful difference of 7 points. This real-world data from the Hannover study is in line with the TENT-A1 study, which observed similar improvements after 6 weeks of treatment and achieved a total of 14.6 points improvement after a full 12 weeks of treatment. Furthermore, there were no reported treatment-related adverse events.

Commenting on the publication of this new analysis, Dr Ross O’Neill, CEO and Founder of Neuromod said: “Results from real-world studies can turn out to be different from those of clinical trials, for a variety of reasons, so it is really encouraging to see that the study performed by Professor Lenarz’s team showed similar levels of efficacy and safety for the Lenire device as in our own large-scale TENT-A1 clinical study, which was published as the cover story in Science Translational Medicine just over a year ago. The Hannover study involved shorter-term use than our studies but we saw similar levels of improvement after 6 weeks of use in the TENT-A1 study. Furthermore, there were no reported treatment-related adverse events with Lenire, confirming the device’s safety in a real-world setting. We are committed to contributing to the body of evidence of using bimodal neuromodulation to treat tinnitus and we were encouraged to see Lenire perform well on studies conducted by eminent Otolaryngology clinicians and researchers, such as Professor Thomas Lenarz and his team in Hannover.”

Lenire works by delivering mild electrical pulses to the tongue, through an intra-oral component called the ‘Tonguetip’, combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.

The TENT-A1 clinical trial, which involved 326 participants across Ireland and Germany, demonstrated Lenire’s efficacy in improving participant’s tinnitus symptoms. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period(iv). When followed up 12 months post treatment, 80.1% of treatment-compliant participants had sustained improvements in their tinnitus symptoms.

The TENT-A1 study represents one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field and was the cover story for the scientific journal Science Translational Medicine in October 2020.

Neuromod specialises in non-invasive neuromodulation technologies and has designed and developed Lenire, which has been used to treat tinnitus patients since 2019.

To date Neuromod has raised significant venture equity and debt financing to fund ongoing expansion of the availability of Lenire in Europe and the organisation’s FDA submission process in the US. This funding has been led by Fountain Healthcare Partners; an international life science focussed venture capital fund.

References

(i) Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.

(ii) Buechner A, Lesinski-Schiedat A, Becker P, Lenarz T, Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus – A case series, Brain Stimulation (2022), doi: https://doi.org/10.1016/j.brs.2022.01.022.

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

(iv) As measured by Tinnitus Handicap Inventory score