Salute e Benessere
Real World Data Supports Lenire Tinnitus Treatment Effectiveness Shown in Large-Scale Clinical Trials
The paper is available at: https://doi.org/10.1101/2024.08.22.24312175
Tinnitus, which is commonly known as , is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans are currently living with tinnitus . Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 2.9 million veterans compensated in 2023 .
The paper, authored by Dr. Emily McMahan , Au. D., of the Alaska Hearing & Tinnitus Center (AHTC) and Professor Hubert Lim , Ph. D. from the University of Minnesota , analyzed the results of patients with moderate or worse tinnitus who treated their tinnitus at AHTC with Lenire between May 2023 and June 2024 .
The analysis of individuals is one of the largest ever conducted of real-world patients following their treatment for tinnitus with a medical device. The retrospective analysis of real-world patients revealed that of patients experienced clinically meaningful reduction in tinnitus after 12-weeks of treatment with Lenire. experienced clinically meaningful reduction in tinnitus after 6-weeks of treatment with Lenire .
of patients said they benefited from treatment with Lenire , where of patients completed 12-weeks of treatment with Lenire .
said Mike McGaughey , Tinnitus Patient at AHTC.
These positive results and high level of patient satisfaction in the real-world patient environment are consistent with clinical trial results and give new hope to the chronically underserved tinnitus patient population.
said AHTC founder, Dr. Emily E. McMahan , Au. D.
Lenire is the first and only tinnitus treatment device of its kind approved by the US FDA following the success of the device's controlled clinical trial, TENT-A3. TENT-A3's results were recently published in Nature Communications.
TENT-A3 included 112 clinical trial participants. 70.5% of those with moderate or worse tinnitus had a clinically meaningful reduction in tinnitus after 6 weeks of using Lenire when sound-alone had no clinically meaningful benefit .
Over the entire TENT-A3 clinical trial, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment .
said Neuromod Chief Scientific Officer and University of Minnesota Professor, Prof. Hubert Lim , Ph.D.
Lenire's real world success is a combination of scientifically proven technology and the expertise of a robust network of leading tinnitus experts. Neuromod, creators of Lenire, train and qualify partner clinics in person and supplement this education with the Lenire Academy learning platform and ongoing clinical affairs support to ensure positive patient outcomes.
Lenire is available in specialized tinnitus clinics in the United States of America and Europe . Lenire is also a treatment option through Veterans Affairs.
Kevin Knight
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+1 (214) 732-9392
Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland , and the United States of America . Neuromod specializes in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions.
The lead application of Neuromod's technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromoddevices.com.
Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials.
Bimodal neuromodulation is the stimulation of nerves with two paired stimuli for therapeutic purposes. The tinnitus treatment device that was used in the study, known as Lenire was developed by Neuromod. It consists of wireless (Bluetooth ) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device trademarked as Tonguetip . The device's settings can be configured to provide treatment with different combinations of audio and electrical stimuli.
The timing, intensity and delivery of the stimuli are controlled by an easy-to-use handheld controller that each participant is trained to use prior to continuing treatment from home. Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an Audiologist or ENT Surgeon, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.
Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received a De Novo Approval Grant by the US FDA.
Dr. Emily E. McMahan , Au. D. is an audiologist who specializes in Diagnostic Hearing & Hearing Management as well as Tinnitus and Tinnitus Management.
Dr. McMahan attended the University of Cincinnati where she received her Bachelor of Science degree in Communication Sciences and Disorders. She furthered her professional education by obtaining her Doctorate of Audiology from Salus University in Philadelphia . She completed her residency in Anchorage and has been applying her expertise to her patients in the Pacific Northwest.
Dr. McMahan holds Board Certification in Audiology through the American Board of Audiology. She is a Fellow of the American Academy of Audiology and the Academy of Doctors of Audiology.
Dr. McMahan was recently elected to a board position and is the Treasurer for Audiology Practice Standards Organization (APSO) which is a group dedicated to creating a national standard of care for the profession of Audiology.
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