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These are over-the-counter, self-fitting air-conduction hearing aids from Huizhou Jinghao Medical Technology. They cleared the FDA through the 510(k) pathway (K221052) as substantially equivalent to an existing device, under the OTC self-fitting hearing aid classification. That means users set them up themselves rather than through a clinic fitting. They suit adults with mild to moderate hearing loss who want to skip a prescription visit. Compared with prescription aids, expect simpler tuning and fewer professional services; compared with other OTC aids, the self-fitting design is the main draw.
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This is a self-fitting, air-conduction hearing aid sold over the counter. It is made by Huizhou Jinghao Medical Technology Co., Ltd. The FDA cleared it under 510(k) number K221052 and found it substantially equivalent to a predicate device.
