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
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Celltrion completes enrolment for global Phase II clinical trial with COVID-19 treatment candidate CT-P5925.11.2020 12:13:00 CETPress release

Celltrion Group today announced enrolment completion of 327 patients with mild-to-moderate symptoms of SARS-CoV-2 infection in the global Phase II clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. Celltrion anticipates submission for emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety (MFDS), conditional on results from the global Phase II pivotal trial. The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection. The trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) and Celltrion is set to obtain the results for global Phase II trial. In addition, Celltrion plans to initiate a global Phase III clinical trial in more than 10 countries in order to obtain more

iHeartMedia and Podimo Partner to Translate and Adapt Widely Popular Podcasts For Listeners Globally25.11.2020 12:00:00 CETPress release

iHeartMedia, the No. 1 audio company in America and the No. 1 podcast publisher globally, and European podcast platform Podimo today announced a strategic partnership to translate and adapt popular podcasts across the globe in different languages, introducing these podcasts to hundreds of millions of new listeners. The partnership will kick off with the widely popular true crime podcast “Forgotten: Women of Juárez” (Olvidadas: Muertes de Juárez) about femicides in Mexico’s most dangerous city in three languages: Spanish, German and Danish. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201125005440/en/ In one of 2020’s most intimate and shocking true crime podcasts, “Forgotten: Women of Juárez,” from iHeartMedia and Unusual Productions, hosts Mónica Ortiz Uribe and Oz Woloshyn investigate theories surrounding the disappearance of hundreds of young women along the Mexican border city of Juárez. Some are tragically found with

RIDDLE&CODE Launches Trusted Gateway to Accelerate the Future of the Distributed Energy Market and Enable New Business Models25.11.2020 10:30:00 CETPress release

The shift from the centralised energy system with a small number of dominant bulk producers to a decentralised renewable marketplace with a multiway flow of information requires not only new business models and entities but also a guarantee that the data generated out of them are trusted and immutable. RIDDLE&CODE laid the foundation for accelerating the future of decentralised energy by introducing the Trusted Gateway. At the core of the Trusted Gateway is the Secure Element, a part of RIDDLE&CODE’s “Built for Blockchain” product range, enabling the secure storage of the digital identity (private key) on any device through a combination of hardware and software. By providing secure public/private key infrastructure, the Trusted Gateway solves the problem of machine identity and creates a unique, cryptographically secured digital representation of an object, assigning it with identity, addressability and transaction capabilities. “In the context of the energy system, by giving the digi

BearingPoint: Organizations That Invest in Frontline Managerial Skills Are More Resilient and Adaptable Than Competitors25.11.2020 08:57:00 CETPress release

The Covid-19 pandemic has shown that organizations that invest in frontline managerial skills are more resilient and adaptable than competitors. Frontline managers initiate process improvements and new ways of working. According to a recent study by the BearingPoint Institute, the research arm of management and technology consultancy BearingPoint, company leaders must make frontline managers a driving force for change to ensure transformation success and adapt to market changes. "With transformational pressures exerting themselves on business, frontline managers have never been more crucial to organizations. Our study shows how important it is to develop, empower and unleash the skills, enthusiasm, and innovation of these leaders. It is the only way to get the most out of digitalization and quickly adapt to the continuously changing market. Investing in frontline management will not only mean continuing success, but it will help you identify and hone tomorrow's leaders," says André Est

European Commission Approves Janssen’s TREMFYA ® ▼ (guselkumab), a First-in-Class Treatment for Active Psoriatic Arthritis (PsA)25.11.2020 08:00:00 CETPress release

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved TREMFYA®▼ (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. Guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor. It is already approved for the treatment of patients with moderate to severe plaque psoriasis. IL-23 is an important driver of the progression of inflammatory diseases including psoriasis and PsA, among others.1 PsA is a multifaceted, chronic, immune-mediated inflammatory disease that is progressive and is characterised by debilitating joint damage and inflammation, in addition to enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis

Universal Peace Federation: 70 Years After the Korean War World Leaders Call for Peace at Online Rally of Hope24.11.2020 19:19:00 CETPress release

Millions of viewers tuned into hundreds of broadcast stations and gathered online to call for peace among and between nations at the third Rally of Hope sponsored by the Universal Peace Federation (UPF) in Korea on Sunday, Nov. 22. UPF was founded in 2005 by Rev. Dr. Sun Myung Moon and Dr. Hak Ja Han Moon and is an NGO in General Consultative Status with the United Nations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201124005906/en/ Dr. Hak Ja Han Moon addresses live audience and online participants from all around the world at the Rally of Hope (Photo: Business Wire) Mrs. Moon announced two new projects: to set up Korean War memorials in those nations that do not yet have them and create an online registry of all those who sacrificed in any way to support Korea during its darkest hour. “All around the world, unforeseen and unexpected challenges are erupting in the realms of politics, economy and religion” she said. “We