US Department of Veterans Affairs (District of Columbia)

91.5% of patients experienced clinically meaningful reductions in tinnitus after 12 weeks of treatment with Lenire. 220 patients were analyzed, making the paper one of the largest real-world analyses of tinnitus patients ever published in a peer-reviewed scientific journal. Real-world outcomes in this paper are consistent with the results of Lenire's large-scale clinical trials. CHICAGO, April 28, 2025 /PRNewswire/ -- Nature Communications Medicine has published the first peer reviewed, real-world analysis of U.S. patients treated with Lenire, the only FDA approved tinnitus treatment device of its kind. Tinnitus afflicts an estimated 25 million American adults and is commonly described as "ringing" in the ears. Continue Reading Lenire Real World Evidence Published in Nature Communications Medicine (PRNewsfoto/Neuromod Devices) Results in the paper titled: "Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting" reported 91.5% of tinnitus patients had a clinically significant reduction in tinnitus. These real-world results are consistent with Lenire's clinical trial results that were instrumental in Lenire being granted De Novo approval by the FDA in March 2023 The paper is available at Nature Communications Medicine: Bimodal neuromodulation is the simultaneous stimulation of two nerves for therapeutic purposes. Lenire plays audio tones via headphones while delivering mild energy pulses to the surface of the tongue to treat tinnitus. Under the care of an audiologist with tinnitus expertise, patients typically use the device at home for two 30-minute sessions daily for an average of 12 weeks. Real World Lenire Outcomes Consistent with Clinical Trials The paper, co-authored by audiologist Emily E. McMahan, Au. D., of the Alaska Hearing and Tinnitus Center (AHTC) and Professor Hubert Lim, Ph. D., from the University of Minnesota, analyzed the results of 220 patients with moderate or worse tinnitus who were treated with Lenire at AHTC between May 2023 and June 2024. This analysis is one of the largest ever conducted of real-world patients following their treatment for tinnitus with a medical device. After an interim check-up after six weeks of treatment with Lenire, 78% had a clinically meaningful reduction in tinnitus. After 12-weeks 91.5% of patients had a clinically meaningful reduction in tinnitus, which demonstrates the effectiveness of a typical treatment protocol with Lenire in a real-world clinical setting.1,5,6 AHTC's results are the first of a series of planned, real-world evidence publications that have been compiled with a base of thousands of patients treated with Lenire. "Publication of this data in Nature Communications Medicine underscores how effective Lenire can be for tinnitus patients when they receive guidance from an experienced tinnitus care professional," said audiologist and AHTC founder, Emily E. McMahan, Au. D. "I am confident we have entered an important new era of tinnitus care". FDA Approval in March 2023 was facilitated by Lenire's controlled, TENT-A3 clinical trial. The results were published in Nature Communications, a journal from the same portfolio. The paper remains in the 99th percentile of more than 250,000 tracked Nature articles.2 TENT-A3 included 112 trial participants and demonstrated Lenire's clinical superiority to sound-only therapy, a widely used treatment for tinnitus.2,5 Nearly 89 percent of trial participants said they would recommend Lenire as a tinnitus treatment.2 "To achieve real-world positive results that are better than what were observed in our previous controlled clinical trial that led to FDA authorization for the Lenire treatment is a major advancement for the tinnitus field," said Neuromod Chief Scientific Officer and University of Minnesota Professor, Hubert Lim, Ph.D. "Publication of Lenire's real-world data in a top-tier scientific journal further validates Lenire's bimodal neuromodulation as a treatment option for tinnitus patients." According to Neuromod Devices founder and CEO, Dr. Ross O'Neill, who was Lenire's principal inventor, "Fifteen percent of the global adult population experiences tinnitus, with many seeking better treatment options. These results show Lenire is successful treating tinnitus in real-world clinical settings". "As scientists and medical professionals, we are committed to evidence-based technology. Part of our DNA at Neuromod is working closely with a passionate network of tinnitus care experts. We train and qualify clinicians and provide ongoing support to help continuously improve clinical best practices and patient outcomes." Lenire is available through specialized tinnitus clinics in the United States of America and Europe. Lenire is also a treatment option through the US Department of Veterans Affairs. References and Notes Mc Mahan, E., and Lim, H., Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting Commun Med (2025). Boedts, M. Beuchner, A. et al. Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial. Nature communications (2024) US VA Benefits Report Fiscal Year 2024: 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. Clinically meaningful reduction in tinnitus is defined as at least 7-points of improvement on the THI scale for the paper. About Neuromod 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 . About Lenire® 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 Devices. 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. About 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 Americans are currently living with tinnitus.3 Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 3.2 million veterans compensated in 2024.4 About Audiologist Emily E. McMahan Au. D. Audiologist Emily E. McMahan, Au. D. the owner of Alaska Hearing and Tinnitus Center. Dr. McMahan specializes in Diagnostic Hearing & Hearing Management as well as Tinnitus and Tinnitus Management. 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 is past-President of Audiology Practice Standards Organization (APSO) which is a nationwide group dedicated to creating a national standard of care for the profession of Audiology. SOURCE Neuromod Devices WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The rise in direct-to-patient therapeutics access via online compounding pharmacies and other direct-to-patient sales models has increased the likelihood of patients utilizing medications alongside other therapeutics and with various complex co-morbidities. With the growth of GLP-1 drugs and the associated direct-to-patient prescribing options, this category of drug is well-positioned to leverage real-world data to identify and demonstrate benefit for patients in other therapeutic areas – beyond current approvals in obesity and diabetes. While GLP-1 drugs are at the forefront of a renewed opportunity for real-world study and surveillance, every new drug and pharmaceutical category can benefit from ongoing post-market surveillance and observational research to identify opportunities for label extension and new patient cohorts that are not initially studied in clinical trials. As real-world data has become more available, most new drug applications to the U.S. Food and Drug Administration (FDA) now include real-world data. This is due, in part, to the 21st Century Cures Act, which requires the FDA to assess real-world data in support of new drug indications and label extensions. presented by Health Tech The 5 Best Software to Buy for Managing a Spa Franchise Choosing the right software translates directly into better client management, operational efficiency and growth for your spa franchise. Discover which tool is best for your business. By Meevo Policymakers, regulatory leaders, and clinical development executives should consider new ways that healthcare stakeholders can gain insight into new drug classes to discern their risks and efficacy when used in real-world contexts. Engaging in data sharing, observational cohort research, and deeper analysis of available data to yield further insights can drive improved results for patients, making label and cohort extension faster and more robust. More robust data sharing among providers will ensure that all prescribers have the most up-to-date information on a patient’s health status. The disparate nature of patient data sharing in the American healthcare system poses a major challenge to prescribers, who often lack line of sight into additional medications used by a patient. When prescribed by another physician, or in cases where the patient does not specifically disclose their full prescription history and lineup, prescribers will not have access to the full picture. Especially in the online compounding model of direct-to-patient access, patients may not be required to provide their medical record to the prescriber, who interacts with the patient in a one-time transaction online. Healthcare provider capabilities – such as medicine reconciliation and health information exchanges – can increase the transparency of data among prescribers. This will facilitate real-world insight into off-label use of therapeutics, any adverse events, and the evolving safety and efficacy profile of a specific medication. These capabilities, which are supported by AI and other innovative technologies, are intended to reduce the risk of contraindications in patients and generate new evidence in support of label and cohort extension. While these tools are effective in cases with extensive safety profiling and risk information, they are not adequately equipped for the large-scale and real-time data sharing requirements of the direct-to-patient prescribing scenario. Sponsored Post Tackling Rising Drug Costs and Growing Popularity of GLP-1’s See how Quantum Health is providing the steps to help their members tackle the cost of specialty medications and other drugs. By Quantum Health and MedCity News Direct-to-patient access channels should leverage these data sharing technologies to access more health information about the patients who use them. Another option is to pursue collaborations with electronic health record companies or healthcare provider organizations to gain a more comprehensive understanding of a patient’s health status and prescription history. This year, the Drug Enforcement Agency (DEA) published proposed rules that recommend telehealth providers participate in a special registry that tracks the prescribing of controlled substances. In the proposed rules, the DEA states, “The rise of DTC online telemedicine platforms in recent years has further transformed healthcare delivery, but it has also introduced new challenges and heightened risks of diversion due to the remote nature of care delivery,” demonstrating the need for improved data sharing and transparency across the industry. Observational research can shed new light on drug interaction risks, and benefits not previously understood in real-world use. Observational studies of co-therapeutic drug use can shed light on the potential risks of usage under conditions that might be unethical for randomization. For example, it would be unethical to randomize a pregnant patient into an interventional trial to test the safety of GLP-1 drugs on maternal and fetal health outcomes. Alternatively, retrospective self-report cohort studies can be used to better understand the outcomes associated with GLP-1 use during pregnancy. Observational study design involves researchers collecting data reported by the study participants on their behavior or exposures. While causation cannot generally be proven through observational research methods, statistical methods can be used to normalize the data and identify associations between behaviors and outcomes that can yield insights that inform clinical recommendations and guidelines. Furthermore, a January 2025 publication in Nature Medicine used a cohort of patients with diabetes generated from the US Department of Veterans Affairs databases (n=215,970) to understand the health effects of GLP-1 drugs, compared to an alternative treatment modality. The observational study found reduced and increased health risks in relation to 175 health outcomes assessed, and the authors conclude that “the results provide insights into the benefits and risks of GLP-1 [drugs] and may be useful for informing clinical care and guiding research agendas.” These insights at the scale observed would have taken much longer to be delivered were it not for observational research. The sheer quantity of real-world data offers new opportunities for clinical development executives and regulators to conduct deeper, more novel analyses As consumer-and patient-reported data platforms proliferate, such as Whoop and Oura, these tools can be used to encourage consumers to report their health behaviors and digitally track their health outcomes. For example, Whoop has published several observational studies based on data gathered by their wearable device. These patient-or user-reported datasets can supplement healthcare records and lab data to facilitate multi-omic analyses to yield further insights and more rigorous cohort stratification. In addition to expanding access to effective and safe medicines to treat novel indications in new patient populations, real world data can improve diagnostics to ensure that patients are treated for the right condition, as evidenced by their healthcare data. For example, real-world data can facilitate early detection and diagnosis by analyzing large datasets from electronic health records, wearable devices, and other sources to identify patterns and anomalies that may indicate the early stages of diseases. Real-world data can also be used to facilitate personalized medicine by developing bespoke diagnostic tools that collect patient health histories, genetic information, and lifestyle data. These insights are gathered through patient-reported channels, electronic medical record data, and other databases. In combination with machine learning and artificial intelligence, diagnostic algorithms can be refined to support patients and healthcare providers to make earlier and more accurate diagnoses, generating essential data to expand use of approved therapeutics into new patient cohorts or health indications. Clinical and observational research can be a valuable tool for proving the risks and benefits associated with prescription use in diverse patient groups and for identifying label extension opportunities. By implementing robust data-sharing, healthcare stakeholders can better understand how emerging products are used in the real world. Improving patient access to therapeutics through direct-to-patient channels will increase the availability of treatment and can offer new opportunities to gather data on real-world use of novel therapeutics. As GLP-1 usage expands, real-world data can support label extension into cardiovascular disease and other indications, including neurodegenerative diseases, PCOS, chronic kidney disease, and others. With more data, pharmaceutical organizations can improve diagnostic protocols, enhance personalization of treatment plans, and better understand potential risks and safety indicators. Rigorous observational research and data-sharing among healthcare stakeholders can support the safe and effective use of all new categories of drugs. Editor’s note: The author has no relationship to any of the companies/products mentioned.

TUESDAY, March 18, 2025 -- The U.S. Department of Veterans Affairs (VA) has announced it will no longer provide hormone therapy to veterans newly diagnosed with gender dysphoria . The decision follows an executive order from President Donald Trump that directs federal agencies to recognize only two sexes, male and female, which “are not changeable,” The New York Times reported. The VA will continue hormone treatments for vets who were already receiving them before the policy change. That's because stopping treatment suddenly could harm a person's health. “I mean no disrespect to anyone, but V.A. should not be focused on helping veterans attempt to change their sex,” said Doug Collins , secretary of veterans affairs. Transgender vets will continue to be welcome at the VA, Collins added, “but if veterans want to attempt to change their sex, they can do so on their own dime.” Since 2011, the VA has provided gender-affirming care, including mental health services, preoperative evaluations and letters supporting procedures, as well as postoperative and long-term care, The Times reported. While the VA has never covered surgeries, it has offered support services like fertility treatments, voice coaching and prosthetic devices. Some VA mental health providers were ordered to remove LGBTQ+ support materials, including rainbow flags and posters stating “All are welcome here.” Mary Brinkmeyer , a psychologist who worked with LGBTQ+ vets at the Hampton VA Medical Center in Virginia, resigned after refusing to take down informational materials. “Our code of ethics is, ‘First do no harm,’ and if you’re caught between an institutional demand and your ethical code, you have to resolve it in favor of the ethics code,” Brinkmeyer said. "The cessation of hormone treatment, along with the recent designation of V.A. bathrooms and inpatient rooms by biological sex, will have a real chilling effect on veterans’ willingness to seek care for gender dysphoria ,” she added. The Times noted that studies suggest that gender dysphoria — a mismatch between a person's biological sex and their gender identity — is more common among vets than the general population. Veterans with gender dysphoria are also up to 20 times more likely to experience suicidal thoughts or events than other VA patients. Brinkmeyer worries that limiting care could put lives at risk. “If veterans don’t have other health insurance -- and many transgender veterans are homeless or underemployed -- will they not seek care if they’re suicidal rather than go to the VA?” Brinkmeyer asked. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.