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          Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
					Guidance for Industry and Food and Drug Administration Staff
		
		August 2022


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2020-D-1380
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Devices and Radiological Health


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). 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.


 
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					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2020-D-1380.

                                                                                  Content current as of:
      10/17/2022
         
                  
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