HyperSound
Directed audio solution employing a fundamentally new way to deliver sound. Device is intended to improve sound clarity and speech intelligibility for individuals with hearing loss. The…
Hearing Aid, Group and Auditory Trainer
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong.
- Shenzhen WAP-Health Technology Co., Ltd. Guangdong
What Is FDA Product Code EPF?
Hearing Aid, Group And Auditory Trainer is FDA product code EPF, Class 2, 21 CFR 874.3320.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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