#Ireland #Dublin #Neuromod Devices #MDSAP Certification #Lenire Tinnitus Device

Neuromod Advances Multiple Regulatory Approvals for Lenire

Neuromod Devices, an innovative medical technology firm, is making significant strides in the realm of tinnitus treatment. Recently, the company announced crucial milestones that enhance the global availability of its Lenire® tinnitus treatment device. This follows the completion of the Medical Device Single Audit Program (MDSAP) certification, a notable achievement that allows for enhanced market entry into Australia and Canada, alongside ongoing availability in Europe.

Understanding the Significance of MDSAP Certification

The MDSAP certification is vital as it confirms Neuromod's compliance with stringent international standards, specifically ISO13485. This certification does not just represent a bureaucratic hurdle; it assures patients and healthcare providers that the device meets high-quality benchmarks in terms of safety and efficacy across various jurisdictions, including Australia’s Therapeutic Goods Administration (TGA) and Canada’s Health Canada. By acquiring these approvals, Neuromod is positioned to widen Lenire's reach to those afflicted by tinnitus in these markets.

Enhancements in Regulatory Framework

The success doesn't end with MDSAP. Neuromod has also achieved compliance with the EU Medical Device Regulation (MDR), which replaces the previous Medical Device Directive (MDD) used in Europe. The MDR mandates a stricter regulatory framework for medical devices, thereby securing the safety and reliability of medical products in their lifecycle from market entry to patient use. As such, they can continue to supply Lenire across European markets and cater to future product development under this robust regulatory umbrella.

Lenire's Historical FDA Approval

Lenire made headlines in 2023 by becoming the first and only FDA-approved bimodal neuromodulation tinnitus treatment device. The groundbreaking device utilizes a unique bimodal approach that combines sound stimulation and electrical impulses, delivered using Bluetooth headphones and a specialized device placed on the tongue. This innovative technology gives patients a non-invasive option to manage their tinnitus—often characterized by a persistent ringing in the ears that impacts daily life for 15% of adults globally.

Clinical Successes with Lenire

The efficacy of Lenire has been confirmed in both large-scale clinical trials and real-world settings. In a notable study published by Nature Communications Medicine, treatment with Lenire resulted in clinically meaningful reductions in tinnitus symptoms for approximately 91.5% of participants. This underscores the promising capabilities of the device in alleviating the distress experienced by tinnitus sufferers.

A Future of Expanding Availability

Dr. Ross O'Neill, founder and CEO of Neuromod, emphasizes the company's commitment to providing top-notch patient care through its state-of-the-art quality management systems. With the MDSAP and MDR certifications now in place, Neuromod is primed to further extend Lenire's availability, not just in Europe, Australia, and Canada, but potentially across other global markets as well.

Diarmuid Flavin, Neuromod’s Chief Operating Officer, adds that these certifications assure healthcare providers and their patients alike that Lenire meets high standards of quality and evidence-driven results, paving the way for wider accessibility in alleviating tinnitus symptoms worldwide.

As the landscape for tinnitus treatment continues to evolve, Neuromod Devices stands at the forefront of innovation, constantly striving to reach more individuals suffering from this often debilitating condition. For further details about Neuromod and Lenire, interested parties can visit the company's official website and explore the quality and regulatory standards they uphold.