QUH

10 FDA 510(k) clearances · Product code

FDA profile

Official device name

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Device class

Class II (moderate risk)

Regulation

21 CFR 874.3325

Medical specialty

Ear, Nose, Throat

FDA definition

A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. 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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