# Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid
> **Food and Drug Administration** · Final order. · Published 2016-01-21 · Effective 2016-01-21 · 81 FR 3325
## Document
- **Document number:** 2016-01090
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 3325
- **CFR reference:** 21 CFR 874
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/01/21/2016-01090/medical-devices-ear-nose-and-throat-devices-classification-of-the-tympanic-membrane-contact-hearing)
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