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QUG — Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter Class II

FDA Device Classification

FDA product code QUG covers "Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter", a Class II medical device regulated under 21 CFR 874.3305. Submissions are reviewed by the Ear, Nose, Throat panel.

Classification Details

Product Code
QUG
Device Class
Class II
Regulation Number
874.3305
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

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.

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