JINGHAO MEDICAL Receives FDA 510k Approval for Self-Fitting OTC Hearing Aids

jinghao otc hearing aids
HHTM
October 25, 2023

HONG KONG, SHANGHAI, & BEIJING — On September 26, 2023, JINGHAO MEDICAL, the first hearing aid manufacturer to be listed in China, achieved a notable milestone. The company’s self-fitting over-the-counter (OTC) hearing aids developed received FDA 510K approval.

Following an extensive clinical testing process and collaborative verification by leading hospitals, JINGHAO MEDICAL’s self-fitting over-the-counter (OTC) hearing aids have obtained FDA approval. The thorough analysis of clinical data affirms their safety and effectiveness, establishing them as on par with, if not surpassing, other FDA-approved hearing aids.

Technological Advancement: Tailored Hearing Solutions

JINGHAO MEDICAL’s self-fitting over-the-counter (OTC) hearing aids employ high-precision hearing test software and intelligent independent fitting strategies.

This innovation aims to offer consumers a customized hearing care experience similar to clinical settings, overcoming the constraints of non-self-fitting hearing aids.

jinghao otc hearing aids

Changing the Landscape for Users

The introduction of self-fitting technology signals a transformation in the hearing healthcare domain. It aligns with the trend of personalized, on-demand solutions, reshaping the way individuals address their hearing requirements.

JINGHAO MEDICAL’s self-fitting technology aims to not only enhances user satisfaction and adoption but also has the potential to reduce overall service costs.

Who is JINGHAO MEDICAL?

JINGHAO MEDICAL is dedicated to delivering accessible and efficient hearing solutions to a broad user base. Their Research and Development (R&D) center is equipped with over 50 experts specializing in hearing aid development and holds more than 200 technology and design patents.

Over the course of producing hearing aids the company reports that it has established collaborations with over 300 hearing aid companies, extending their services to more than 10 million users globally.

The Path Forward

In the near future, innovations approved under 510K will become increasingly available in over-the-counter (OTC) hearing aids, making them accessible through retail stores and online platforms.

Mr. Felix, the Chief Financial Officer of JINGHAO MEDICAL, emphasized the primary concern of users for safe and effective devices:

“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. “

Source: Huizhou Jinghao Medical Technology Co., Ltd

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