QUF · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.3300
Classification
FDA Product Code
QUF
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 874.3300
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.