Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid
fda-device · Food and Drug Administration · Rule · Published 2016-01-21 · Effective 2016-01-21 · 81 FR 3325
Document
Document number
2016-01090
Federal Register citation
81 FR 3325
CFR reference
21 CFR 874
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-01-21
Effective date
2016-01-21
HHS docket
Docket No. FDA-2015-N-4328
Abstract
The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic membrane contact hearing aid's classification. 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.