{"abstract":"The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with the 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 will become obsolete as a result of changes to the hearing aid requirements. 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":"Final 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/2022/08/17/2022-17230.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":"87 FR 50698","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date: This rule is effective October 17, 2022.","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 Aids","document_id":"FDA-2021-N-0555-1148"},{"title":"Reference 13 - New HRCT-Based Measurements of Human Ear Canal RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids","document_id":"FDA-2021-N-0555-1146"},{"title":"Reference 9 - Occupational Noise Exposure NIOSH 98-126 RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids","document_id":"FDA-2021-N-0555-1142"},{"title":"Reference 8 - ANSI-CTA 2051 2017 (FINAL) RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids","document_id":"FDA-2021-N-0555-1141"},{"title":"Reference 3 - NIH Fact Sheet - Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids","document_id":"FDA-2021-N-0555-1136"},{"title":"Reference 1 - Hearing Loss Prevalence in the US RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids","document_id":"FDA-2021-N-0555-1134"},{"title":"Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids","document_id":"FDA-2021-N-0555-1132"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2022-08-17","updated_at":"2023-02-27T21:23:16.171-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0555-1132","allow_late_comments":null,"id":"FDA-2021-N-0555-1132","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":77,"id":"FDA-2021-N-0555","title":"Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations"}],"document_number":"2022-17230","effective_on":"2022-10-17","end_page":50762,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/08/17/2022-17230.xml","html_url":"https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids","images":{"ER17AU22.013":{"large":"https://img.federalregister.gov/ER17AU22.013/ER17AU22.013_large.png","medium":"https://img.federalregister.gov/ER17AU22.013/ER17AU22.013_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.013/ER17AU22.013_original_size.png"},"ER17AU22.012":{"large":"https://img.federalregister.gov/ER17AU22.012/ER17AU22.012_large.png","medium":"https://img.federalregister.gov/ER17AU22.012/ER17AU22.012_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.012/ER17AU22.012_original_size.png"},"ER17AU22.011":{"large":"https://img.federalregister.gov/ER17AU22.011/ER17AU22.011_large.png","medium":"https://img.federalregister.gov/ER17AU22.011/ER17AU22.011_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.011/ER17AU22.011_original_size.png"},"ER17AU22.010":{"large":"https://img.federalregister.gov/ER17AU22.010/ER17AU22.010_large.png","medium":"https://img.federalregister.gov/ER17AU22.010/ER17AU22.010_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.010/ER17AU22.010_original_size.png"},"ER17AU22.017":{"large":"https://img.federalregister.gov/ER17AU22.017/ER17AU22.017_large.png","medium":"https://img.federalregister.gov/ER17AU22.017/ER17AU22.017_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.017/ER17AU22.017_original_size.png"},"ER17AU22.016":{"large":"https://img.federalregister.gov/ER17AU22.016/ER17AU22.016_large.png","medium":"https://img.federalregister.gov/ER17AU22.016/ER17AU22.016_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.016/ER17AU22.016_original_size.png"},"ER17AU22.015":{"large":"https://img.federalregister.gov/ER17AU22.015/ER17AU22.015_large.png","medium":"https://img.federalregister.gov/ER17AU22.015/ER17AU22.015_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.015/ER17AU22.015_original_size.png"},"ER17AU22.014":{"large":"https://img.federalregister.gov/ER17AU22.014/ER17AU22.014_large.png","medium":"https://img.federalregister.gov/ER17AU22.014/ER17AU22.014_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.014/ER17AU22.014_original_size.png"},"ER17AU22.019":{"large":"https://img.federalregister.gov/ER17AU22.019/ER17AU22.019_large.png","medium":"https://img.federalregister.gov/ER17AU22.019/ER17AU22.019_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.019/ER17AU22.019_original_size.png"},"ER17AU22.018":{"large":"https://img.federalregister.gov/ER17AU22.018/ER17AU22.018_large.png","medium":"https://img.federalregister.gov/ER17AU22.018/ER17AU22.018_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.018/ER17AU22.018_original_size.png"},"ER17AU22.002":{"large":"https://img.federalregister.gov/ER17AU22.002/ER17AU22.002_large.png","medium":"https://img.federalregister.gov/ER17AU22.002/ER17AU22.002_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.002/ER17AU22.002_original_size.png"},"ER17AU22.024":{"large":"https://img.federalregister.gov/ER17AU22.024/ER17AU22.024_large.png","medium":"https://img.federalregister.gov/ER17AU22.024/ER17AU22.024_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.024/ER17AU22.024_original_size.png"},"ER17AU22.001":{"large":"https://img.federalregister.gov/ER17AU22.001/ER17AU22.001_large.png","medium":"https://img.federalregister.gov/ER17AU22.001/ER17AU22.001_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.001/ER17AU22.001_original_size.png"},"ER17AU22.023":{"large":"https://img.federalregister.gov/ER17AU22.023/ER17AU22.023_large.png","medium":"https://img.federalregister.gov/ER17AU22.023/ER17AU22.023_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.023/ER17AU22.023_original_size.png"},"ER17AU22.000":{"large":"https://img.federalregister.gov/ER17AU22.000/ER17AU22.000_large.png","medium":"https://img.federalregister.gov/ER17AU22.000/ER17AU22.000_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.000/ER17AU22.000_original_size.png"},"ER17AU22.022":{"large":"https://img.federalregister.gov/ER17AU22.022/ER17AU22.022_large.png","medium":"https://img.federalregister.gov/ER17AU22.022/ER17AU22.022_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.022/ER17AU22.022_original_size.png"},"ER17AU22.021":{"large":"https://img.federalregister.gov/ER17AU22.021/ER17AU22.021_large.png","medium":"https://img.federalregister.gov/ER17AU22.021/ER17AU22.021_medium.png","original_size":"https://img.federalregister.gov/ER17AU22.021/ER17AU22.021_original_size.png"}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