Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid
fda-device · Food and Drug Administration · Rule · Published 2011-06-15 · Effective 2011-07-15 · 76 FR 34845
Document
Document number
2011-14790
Federal Register citation
76 FR 34845
CFR reference
21 CFR 874
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2011-06-15
Effective date
2011-07-15
HHS docket
Docket No. FDA-2011-N-0361
Abstract
The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.