FDA product code QUG: Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

QUG is the FDA product code for hearing aid, air-conduction with wireless technology, over the counter. It is a Class II device, regulated under 21 CFR 874.3305 and reviewed by the Ear, Nose and Throat panel. Devices under QUG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for QUG devices, 1 initiated in the last five years.

Definition

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.

Classification

Recalls for QUG devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-25.

Frequently asked questions

What is FDA product code QUG?

QUG is the FDA product code for hearing aid, air-conduction with wireless technology, over the counter. It is a Class II device, regulated under 21 CFR 874.3305 and reviewed by the Ear, Nose and Throat panel.

What device class is QUG?

Class II, regulation 21 CFR 874.3305. Typical premarket route: 510(k) exempt.

Have QUG devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2025-04-25.

Next steps

• Run an FDA pathway report with predicate devices for product code QUG
• Run a recall and safety report across every QUG manufacturer
• Watch product code QUG for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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