QUF — Hearing Aid, Air-Conduction, Over The Counter Class I
FDA product code QUF covers "Hearing Aid, Air-Conduction, Over The Counter", a Class I medical device regulated under 21 CFR 874.3300. Submissions are reviewed by the Ear, Nose, Throat panel.
Classification Details
- Product Code
- QUF
- Device Class
- Class I
- Regulation Number
- 874.3300
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.