JINGHAO MEDICAL’s Self-fitting OTC Hearing Aids Received FDA 510(k) Approval

As the first hearing aid manufacturer to be listed in China, JINGHAO MEDICAL has once again taken a historic step. On September 26, 2023, the self-fitting OTC hearing aid developed and manufactured by JINGHAO MEDICAL officially received FDA 510K approval.

This approval has the following important significance for the hearing aid market:

1. Safety and effectiveness: with two years of clinical testing, joint verification by multiple well-known hospitals, and strict FDA review process, the submission and review of each clinical data represents that the self-fitting OTC hearing aids researched and developed of JINGHAO MEDICAL approved to be effective. It is fully proven that JINGHAO’s hearing aids have the same or even safer and more effective quality than other FDA-approved hearing aids.

2. Technological innovation: JINGHAO MEDICAL self-fitting OTC hearing aids are equipped with high-precision hearing test software and intelligent independent fitting strategies, providing consumers with the same precise hearing care experience as those in clinics, breaking through the barrier of non-self-fitting hearing aids that the threshold cannot be personalized. It also means JINGHAO MEDICAL’s technical advantages in hearing aid market applications and user experience.

3. Increase user satisfaction and adoption: The approved application of self-fitting technology not only propels JINGHAO MEDICAL into the forefront of the hearing aid industry, but also revolutionizes the way individuals access and manage their hearing needs. It represents a paradigm shift in healthcare, aligned with the trend toward personalized, on-demand solutions. Not only that, JINGHAO MEDICAL’s self-fitting technology can also effectively improve user satisfaction and adoption rates, while reducing overall service costs.


JINGHAO MEDICAL is a manufacturer committed to providing effective and easy-to-use hearing solutions to more users. 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.

JINGHAO MEDICAL provides complete hearing aid applications and solutions

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.

MR. FELIX, the CFO of JINGHAO MEDICAL said, “The biggest concern of users is whether they can have a hearing aid that is safe, effective and suitable for them. Therefore, improving the self-fitting technology of hearing aids is one of the steps in our provision of hearing aid solutions. We are also developing solutions that enable users to obtain usage guidance and services independently, thereby achieving smooth use results and further improving customer satisfaction. This will be a major advancement in the OTC hearing aid industry. We are very excited and look forward to it. “

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