Business Wire

Neuromod Publishes Results of Large-Scale Tinnitus Clinical Trial in Peer-Reviewed Top-Tier Scientific Journal

Share

Neuromod Devices Limited (“Neuromod”), the Irish medical device company specialising in the treatment of chronic tinnitus, commonly described as ‘ringing in the ears’, has published the results of the Company’s TENT A1 (Treatment Evaluation of Neuromodulation for Tinnitus) clinical trial in this week’s edition of Science Translational Medicine in a paper titled: ‘Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study’.

The clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity. The trial investigated the bimodal neuromodulation approach, using Neuromod’s non-invasive stimulation device that delivers sound to the ears and electrical stimulation to the tongue.

The study represents the largest and longest followed-up clinical trial ever conducted in the tinnitus field with 326 enrolled participants, providing evidence regarding the safety, efficacy and patient tolerability of bimodal neuromodulation for the treatment of tinnitus. 86.2% of treatment compliant participants reported an improvement in tinnitus symptom severity when evaluated after 12 weeks of treatment, with many experiencing sustained benefit 12 months post-treatment.

The study was conducted at the Wellcome Trust-HRB Clinical Research Facility, St. James’s Hospital, Dublin, Ireland and the Tinnituszentrum of the University Regensburg, Germany. There were consistent therapeutic outcomes across both clinical sites, with no SAEs Serious Adverse Events (SAEs related to the treatment and a high satisfaction rate across a large cohort of participants. A Medical Research Organization (NAMSA, Minneapolis, Minnesota, USA) guided and assisted the close-out process of Neuromod’s clinical trial.

The tinnitus treatment device, now branded as Lenire®, which was used in the study was developed by Neuromod and consists of wireless (Bluetooth®) headphones that deliver sequences of audio tones layered with wideband noise to both ears, combined with electrical stimulation pulses delivered to 32 electrodes on the tip of the tongue by a proprietary device trademarked as Tonguetip®. The timing, intensity and delivery of the stimuli are controlled by an easy to use handheld controller that each participant is trained to use. 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.

For the trial, participants were instructed to use the Lenire® device for 60 minutes daily for 12 weeks. Out of 326 enrolled participants, 83.7% used the device at or above the minimum compliance level of 36 hours over the 12-week treatment period. For the primary endpoints, participants achieved a statistically and clinically significant reduction in tinnitus symptom severity.

When treatment was completed, participants returned their device and were assessed at three follow-up visits up to 12 months. 66.5% of participants who filled out the exit survey (n=272) affirmed they had benefited from using the device and 77.8% (n=270) said they would recommend the treatment for other people with tinnitus.

Participants in the study were screened and selected based on a pre-defined list of inclusion and exclusion criteria to ensure the trial had a wide distribution sample of the tinnitus population. More information on the criteria can be found on https://www.clinicaltrials.gov/ using the identifier NCT02669069 and the full paper can be accessed here: https://www.neuromoddevices.com/tenta1results.

Dr Ross O’Neill, Founding CEO of Neuromod commented:“We are delighted to announce the publication of positive results from our TENT-A1 clinical trial, which has shown significant improvements in tinnitus symptoms in patients using our unique Lenire® device. There is a globally recognised clinical need for evidence-based treatments for tinnitus, such as Lenire®, due to the lack of effective options for this debilitating condition. Neuromod is proud to be at the cutting edge of efforts to research and develop new solutions that can contribute to solving this chronic condition that affects 10-15% of the population worldwide. We are committed to continuing our research in the field and to advance our unique chronic tinnitus treatment technology”.

Hubert Lim, Chief Scientific Officer of Neuromod commented: “I am truly proud of our Company’s ability to perform such a large-scale randomised clinical trial in two countries, enrolling 326 participants to demonstrate the safety and efficacy of a new solution for tinnitus. This study tracked the post-treatment therapeutic effects for 12 months, which is a first for the tinnitus field in evaluating the long-term outcomes of a medical device approach. The outcomes are very exciting and I look forward to continuing our work to develop a bimodal neuromodulation treatment to help as many tinnitus sufferers as possible.”

About Neuromod Devices Limited

Neuromod Devices Limited (“Neuromod”), headquartered in the Digital Hub, Dublin, Ireland, is a medical technology company, specialising 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 company was founded in 2010, by Dr. Ross O’Neill. 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 which no standard of care has yet been established. Neuromod’s tinnitus treatment device Lenire® has been commercialised in Europe and is available in Ireland, Belgium and Germany. Tinnitus affects between 10 and 15% of the global population, and the lives of at least 1 in every 100 people worldwide are severely compromised because of the incessant nature of the illusory sound that is often described as a ringing or buzzing in the ears.

www.NeuromodDevices.com

About Lenire®

Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment 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 on Lenire® including a list of providers can be found under www.lenire.com.

About Science Translational Medicine

The Science family of journals is published by the American Association for the Advancement of Science (AAAS), the world’s oldest and largest general science organization. The Science magazine has been at the centre of important scientific discovery since its founding in 1880, and continues to publish the very best in research across the sciences, with articles that consistently rank among the most cited in the world. Science Translational Medicine is an essential platform for peer-reviewed, multidisciplinary research driving the latest medical advances to complement the discoveries in the Science magazine.

Contact information

FTI Consulting | Media Relations
Melanie Farrell
Aline Oliveira
T: +353 1 6633686
T: +353 86 401 5250
neuromod@fticonsulting.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

PMI Announces Medicago to Supply Up to 76 Million Doses of Its Plant-Derived COVID-19 Vaccine Candidate23.10.2020 20:00:00 CESTPress release

Since 2008, Philip Morris Investments B.V. (PMIBV), a subsidiary of Philip Morris International (PMI) (NYSE: PM), has been a shareholder of Medicago (in which it currently holds an approximately one-third equity stake) and has supported Medicago’s innovative plant-derived research and development focused on vaccines. The investment is consistent with PMI’s own efforts to leverage science and innovation. Japan-based Mitsubishi Tanabe Pharma Corporation (MTPC) is the majority shareholder and PMIBV’s partner in Medicago. Among other things, PMIBV and MTPC will contribute additional funding to support Medicago’s efforts to develop a COVID-19 vaccine candidate. Medicago, a biopharmaceutical company headquartered in Quebec City, announced that it reached an agreement with Public Services and Procurement Canada (PSPC) to supply up to 76 million doses of its vaccine candidate for COVID-19, subject to Health Canada approval. Innovation, Science & Economic Development (ISED), another department

Fujikura Enters 5G mmWave Infrastructure Market With the Introduction of Industry’s Highest Performance, and Low Power Consumption Phased Array Antenna Module (PAAM)23.10.2020 10:00:00 CESTPress release

Fujikura Ltd. (TOKYO:5803) (President & CEO: Masahiko Ito) today announced the introduction of industry’s most advanced and highly integrated Phased Array Antenna Module (PAAM) for 5G mmWave operating in 3GPP bands n257 (28 GHz), n258 (26 GHz) and n261 (27 GHz). The Fujikura PAAM is the industry’s highest performance PAAM targeting indoor and outdoor applications such as 5G mmWave Fixed Wireless Access (FWA), 5G mmWave Mobile Wireless Access (MWA), 5G mmWave wireless backhaul, and other emerging applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201023005099/en/ Fig.1 Block diagram of Fujikura PAAM. (Graphic: Business Wire) Key Differentiating Features of the Fujikura PAAM The Fujikura PAAM is a high performance phased array antenna module with a novel integrated antenna, and supports concurrent dual polarized beams in both transmission and reception (Fig.1). The PAAM integrates best-in-class mmWave-ICs developed i

VAAST Bikes Now Available in Europe23.10.2020 09:02:00 CESTPress release

VAAST Bikes, a forward-thinking bicycle manufacturer known for its innovative Allite® Super Magnesium™ frames, has signed an agreement with German cycling-specialist retailer giant Internetstores (Fahrrad.de/Brügelmann.de/Bikester). Two of VAAST’s key bicycle models – including the gravel-ready all-road A/1 bike, and the urban U/1 – are now stocked at Internetstores’ eCommerce sites. Both VAAST models will be available to order online for delivery in fourteen locations across Europe via Fahrrad.de/Brügelmann.de in Germany and the partner site Bikester in 13 countries, including the UK, France, the Netherlands, Belgium, Switzerland, Austria, Poland, Denmark, Italy, Sweden, Norway, Finland and Spain. Customers in Germany can benefit from personal service in Fahrrad.de’s five stores and 190 local service partners, while eCommerce customers Europe-wide will be able to receive their new VAAST bicycle within just days of ordering online. VAAST’s unique position as the only bicycle manufactur

Mitsubishi Chemical Holdings Corporation: Notice Regarding Change in Representative Corporate Executive Officers23.10.2020 08:40:00 CESTPress release

Mitsubishi Chemical Holdings Corporation (“MCHC”) (TOKYO: 4188) announced that, at the meeting of its Board of Directors held today, it resolved change of representative corporate executive officers as outlined below. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201022006285/en/ Jean-Marc Gilson (Photo: Business Wire) 1. Change in Representative Corporate Executive Officers (Appointed) Name: Jean-Marc Gilson Title: Representative Corporate Executive Officer President and Chief Executive Officer (Retiring) Name: Hitoshi Ochi Title: Representative Corporate Executive Officer President and Chief Executive Officer 2. Biographical Sketch of New Representative Corporate Executive Officer Refer to the appendix 3. Scheduled Date of Appointment April 1, 2021 4. Reason for the Change MCHC converted to a company with a nominating committee, etc. in June 2015. Since then, the Nominating Committee has carried out preparations to proper

MYAH Wins Prestigious Silmo D’Or Award23.10.2020 07:00:00 CESTPress release

Topcon Healthcare, a leading provider of medical devices and software solutions for the global eye care community, announced today that its MYAH myopia and dry eye management device has won the 2020 Silmo D’Or Award in the Material/Equipment category. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201022005242/en/ Topcon Healthcare announced today that its MYAH myopia and dry eye management device has won the 2020 Silmo D’Or Award. (Photo: Business Wire) The Silmo D’Or Awards are presented each year to recognize creativity in optical product design, innovation and technology. This year marked the 27th annual awards ceremony, which was held virtually and live streamed online on Saturday, October 3rd. The award committee was proud to recognize forward-thinking companies who have continued to launch products and propel the industry forward despite the global pandemic. MYAH came out on top in the Material/Equipment category and

ABB: Q3 2020 Results23.10.2020 06:46:00 CESTPress release

“Third quarter revenues in all business areas were still dampened due to the impact of COVID-19, although a strong recovery in China and ongoing cost mitigation efforts supported a strong underlying performance. On the upside, the integration of GEIS and turnaround of Installation Products in Electrification is starting to bear fruit and Motion is performing robustly. Robotics and Industrial Automation, on the other hand, are taking more time to recover,” said Björn Rosengren, CEO of ABB. “We are pushing ahead with the decentralization of the group and the ongoing review of our portfolio, while carrying out our share buyback program as planned. We look forward to presenting further details on our strategic progress at our Capital Markets Day on November 19.” KEY FIGURES CHANGE CHANGE ($ millions, unless otherwise indicated) Q3 2020 Q3 2019 US$ Comparable 9M 2020 9M 2019 US$ Comparable Orders 6,109 6,688 -9% -8% 19,509 21,702 -10% -7% Revenues 6,582 6,892 -4% -4% 18,952 20,910 -9% -7% I

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom