Regulatory requirements for hearing aid devices and personal sound amplification products: guidance for industry and Food and Drug Administration staff

Regulatory requirements for hearing aid devices and personal sound amplification products: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022
Language(s):
English
Format:
Text
Subject(s):
Device Approval
Government Regulation
Hearing Aids
United States
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance document identifies applicable legal requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs). Hearing aids and PSAPs both affect a user’s ability to hear sound, but the products have different intended uses, and are therefore subject to different regulatory controls. Unlike hearing aids which are intended to aid a person with or compensate for hearing impairment, PSAPs (as defined in Section III) are not intended to diagnose, treat, cure, mitigate, or prevent disease and are not intended to affect the structure or function of the body. Therefore, they are not considered to be “devices” as defined in the FD&C Act. A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer confusion. This guidance is intended to describe hearing aids, PSAPs, their respective intended uses, and the regulatory requirements that apply to both types of products. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (10 pages))
NLM Unique ID:
9918486678306676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918486678306676