Jinghao Medical, a hearing aid manufacturer based in China, announced that its self-fitting over-the-counter (OTC) hearing aid has received FDA 510K approval.
With two years of clinical testing, joint verification by multiple well-known hospitals, and a strict FDA review process, the submission and review of each clinical data shows that the self-fitting OTC hearing aids researched and developed by Jinghao Medical were approved to be effective, the company says. Jinghao Medical’s self-fitting OTC hearing aids are equipped with high-precision hearing test software and intelligent independent fitting strategies, which aim to provide consumers with a precise hearing care experience.
Jinghao Medical says the approved application of self-fitting technology seeks to propel the company into the forefront of the hearing aid industry and revolutionize the way individuals access and manage their hearing needs.
Who is Jinghao Medical?
Jinghao Medical is a manufacturer committed to providing effective and easy-to-use hearing solutions to more users, the company says. Jinghao Medical’s innovation R&D center has more than 50 hearing aid R&D experts and more than 200 technology and appearance patents. Since the production of hearing aids, it has cooperated with more than 300 hearing aid companies and served more than 10 million users around the world.
Further reading: OTC Hearing Aids Aren’t Attracting Buyers Yet
Soon, technological innovations approved under 510K will also appear in more over-the-counter (OTC) hearing aids and be sold to the public in retail stores and online platforms. At the same time, Jinghao Medical will also use more advanced technology and higher quality standards to provide more hearing aid service providers and users with complete hearing aid applications and solutions that are more humane and user-friendly, the company says.
Photo: Jinghao Medical