What Is This Device?
A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.
What Is FDA Product Code QUG?
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter is FDA product code QUG, Class 2, 21 CFR 874.3305.
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.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2025. 1 was by a company in China. The root cause the FDA records most often is Labeling design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.