Federal Register Proposed rule and direct final rule: FDA is proposing to amend its regulations on hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. It will change the identification of the standard from “American National Standard ‘Specification of Hearing Aid Characteristics,’ ANSI S3.22-1996” to “American National Standard ‘Specification of Hearing Aid Characteristics,’ANSI S3.22-2003.”

The agency will require manufacturers to use state-of-the-art methods to provide technical data in hearing aid labeling. FDA is also proposing to update an address and remove an outdated requirement. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. To view this proposed rule, click here.