Author: Neil Doyle

• 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