NewSound’s Commitment to Medical Device Excellence: MDD, MDR, and Beyond

XIAMEN, China, Sept. 20, 2024 /PRNewswire/ — Founded in 2004, the whole family of NewSound has been devoting to offering great hearing aids with affordable price to the hearing impaired around the world. Since its establishment, NewSound has been relentlessly pursuing quality. In 2008, NewSound Technology achieved a milestone by obtaining official medical device certification from the European Union, marking its position as one of the earliest Chinese hearing aid manufacturers to gain widespread recognition in the European and American markets. For over two decades, NewSound has tirelessly pursued quality & global expansion, elevating manufacturing standards to support customer growth. Recognized by regulators in Canada, Korea, & beyond, it’s gained market access worldwide.

The European Union’s Medical Device Directive (MDD), recognized as one of the most stringent global standards for medical devices, has consistently served as a benchmark that NewSound Technology strictly adheres to and surpasses. NewSound Technology’s MDD certification has been approved to remain valid until 2028, which not only affirms the continuous stability of its product quality, but also stands as a testament to the company’s ongoing innovation and progress. Facing new challenges and opportunities, NewSound Technology has proactively initiated the introduction of the Medical Device Regulation (MDR), with the aim of continuing to lead the industry forward and providing users worldwide with even safer, more efficient, and more innovative hearing solutions.

In the United States, after securing FDA certification in 2009, NewSound did not rest on its laurels. It faced rigorous audits from major retailers like Walmart and other pharmacies, demonstrating its unwavering commitment to excellence. As the Over-the-Counter (OTC) hearing aid regulations emerged, NewSound seized the opportunity to lead the way. Recognizing the potential to democratize access to hearing aids, the company delved into the nuances of the new regulations, swiftly adapting its manufacturing and testing protocols to exceed these standards. This proactive approach allowed NewSound to promptly introduce its OTC hearing aid series, offering consumers a range of affordable, accessible, and high-quality hearing solutions which registered in the relative Classification of OTC hearing aid.

Join us in shaping the future of medical device excellence with NewSound Technology.

Media Inquiries:
Julie Wang
86 592 39211713
383485@email4pr.coom
Corporate website: usnewsound.com

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SOURCE NewSound Technology