510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QUGClass II

Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

21 CFR 874.3305 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QUG is the FDA product code for Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter, a class II device type, regulated under 21 CFR 874.3305. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QUG
Device name
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
FDA 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.
Regulation
21 CFR 874.3305
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 87 companies shown, in name order