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Lenire Recognized by American Academy of Otolaryngology for Tinnitus Treatment

In a groundbreaking development for individuals suffering from tinnitus, Lenire, the innovative bimodal neuromodulation device produced by Neuromod Devices, has been officially included in the clinical practice guidelines established by the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF). This marks the first time since the guidelines' inception in 2014 that a new treatment option has been added, paving the way for enhanced care for millions of Americans affected by this condition.

Historical Inclusion in Clinical Guidelines

The inclusion of Lenire signifies a substantial advancement in the management of tinnitus. The AAO-HNSF developed these clinical guidelines to assist ENT specialists across the United States in evaluating and treating tinnitus. Their focus is on endorsing interventions that have been shown to be beneficial while advising against those that are expensive, time-consuming, or lack efficacy. According to Dr. Ross O'Neill, the founder of Neuromod, this addition is not only a major milestone for Neuromod but also a significant step forward in the realm of tinnitus treatment.

Lenire stands out as the sole newly recommended treatment in the AAO-HNSF guidelines since their establishment, highlighting its unique position within the medical community. The device, which utilizes bimodal neuromodulation—a combination of sound stimulation and mild electrical stimulation applied to the tongue—is the first and only FDA-approved device in its category. This endorsement from the AAO-HNSF is based on rigorous clinical evaluations conducive to its efficacy and safety.

Evidence Supporting Lenire’s Effectiveness

The scientific foundations for Lenire’s recommendation are robust. Research conducted through large-scale clinical trials has repeatedly validated its capacity to effectively reduce the symptoms of tinnitus. Dr. O'Neill expressed confidence in the healthcare community's ability to recommend Lenire, emphasizing that the treatment has undergone thorough review by tinnitus experts and has demonstrated promising results. The clinical data demonstrates that the device not only alleviates symptoms but also improves the quality of life for patients living with tinnitus.

The historical FDA clearance of Lenire in March 2023 was supported by pivotal research findings, specifically from the TENT-A3 clinical trial. With results published in Nature Communications, the compelling data positions Lenire amongst the top percentile of acclaimed articles—acknowledged for their impacts in the medical field.

To date, Lenire has successfully treated tens of thousands of patients in clinics across the United States, with the intention of providing continuous support to healthcare professionals through ongoing research initiatives. Such developments not only reinforce Lenire's effectiveness but also seek to establish the device as a leading standard of care in managing tinnitus.

Real-World Outcomes

Recent studies conducted in real-world clinical settings add even more confidence to the efficacy of Lenire. One significant study published in Nature Communications Medicine highlighted a remarkable 91.5% of patients experiencing clinically meaningful reductions in tinnitus symptoms following treatment. Similarly, research featured in The American Journal of Audiology confirmed that 81.8% of patients with troublesome tinnitus noted substantial symptom relief.

Professor Hubert Lim, the Chief Scientific Officer at Neuromod, reiterated the importance of the guidelines, stating that the inclusion of bimodal neuromodulation in the AAO-HNSF practice guidelines highlights the substantial clinical evidence backing Lenire as a viable treatment option for patients in search of relief from bothersome tinnitus.

Going forward, Neuromod is firmly committed to enriching the evidence base for Lenire, ensuring it remains effective and accessible globally. The device is currently available not only in the United States but also in Canada, Australia, and various European countries, with healthcare providers licensed to prescribe it.

In summary, the inclusion of Lenire in the AAO-HNSF guidelines represents a significant shift in the treatment landscape for tinnitus, offering hope and relief to the millions it affects annually.

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For further information on Lenire and its utilization, visit www.neuromod.com or consult with qualified healthcare professionals.

Contact Information

• - Media Contacts:

- Europe: Joseph Roche, [email protected], +353 (87) 416 0138
- North America: Kevin Knight, [email protected], +1 (214) 732-9392

About Neuromod Devices

Neuromod Devices, headquartered in Ireland, specializes in creating medical technologies aimed at addressing clinical needs in tinnitus care. With extensive clinical trials underpinning the safety and effectiveness of Lenire, the company aims to set new standards in tinnitus management.