{"abstract":"The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2021/10/20/2021-22473.html","cfr_references":[{"chapter":null,"citation_url":null,"part":800,"title":21},{"chapter":null,"citation_url":null,"part":801,"title":21},{"chapter":null,"citation_url":null,"part":808,"title":21},{"chapter":null,"citation_url":null,"part":874,"title":21}],"citation":"86 FR 58150","comment_url":null,"comments_close_on":"2022-01-18","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by January 18, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 19, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0555"],"dockets":[{"supporting_documents":[{"title":"TAB B 2022-111 OTC Hearing Aids Final Rule Track Changes RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule","document_id":"FDA-2021-N-0555-1169"},{"title":"EA Reference 13 - FN - Hearing Aids Cost More Than Their Weight in Gold RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids","document_id":"FDA-2021-N-0555-1164"},{"title":"Environmental Assessment FONSI RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids","document_id":"FDA-2021-N-0555-1155"},{"title":"RIA Reference 1 - The Big Six Hearing Aid Companies RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing 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and services","Packaging and containers","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":86}