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QUFClass I

Hearing Aid, Air-Conduction, Over The Counter

21 CFR 874.3300 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QUF is the FDA product code for Hearing Aid, Air-Conduction, Over The Counter, a class I device type, regulated under 21 CFR 874.3300. FDA's definition for this code reads: "An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. 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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QUF
Device name
Hearing Aid, Air-Conduction, Over The Counter
FDA definition
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. 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 874.3300
Device class
Class I
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
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 79 companies shown, in name order