{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-2021-N-0555\" sorted by posted_date descending", "rows": [["FDA-2021-N-0555-1173", "FDA", "FDA-2021-N-0555", "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals", "Notice", "General Notice", "2022-12-15T05:00:00Z", 2022, 12, "2022-12-15T05:00:00Z", null, "2022-12-15T21:57:11Z", "2022-27192", 0, 0, "0900006485534831"], ["FDA-2021-N-0555-1169", "FDA", "FDA-2021-N-0555", "TAB B 2022-111 OTC Hearing Aids Final Rule Track Changes RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule", "Supporting & Related Material", "Background Material", "2022-09-06T04:00:00Z", 2022, 9, null, null, "2022-09-06T18:49:53Z", null, 0, 0, "09000064852b4f21"], ["FDA-2021-N-0555-1170", "FDA", "FDA-2021-N-0555", "TAB B 2022-111 OTC Hearing Aids RIA Track Changes RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule", "Supporting & Related Material", "Background Material", "2022-09-06T04:00:00Z", 2022, 9, null, null, "2022-09-06T18:49:59Z", null, 0, 0, "09000064852b4f4d"], ["FDA-2021-N-0555-1167", "FDA", "FDA-2021-N-0555", "TAB A 2022-111 OTC Hearing Aids Final Rule as Submitted to OMB RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule", "Supporting & Related Material", "Background Material", "2022-09-06T04:00:00Z", 2022, 9, null, null, "2022-09-06T18:49:37Z", null, 0, 0, "09000064852b4809"], ["FDA-2021-N-0555-1171", "FDA", "FDA-2021-N-0555", "TAB C 2022-111 OTC Hearing Aids Final Rule as Cleared by OMB RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule", "Supporting & Related Material", "Background Material", "2022-09-06T04:00:00Z", 2022, 9, null, null, "2022-09-06T18:50:06Z", null, 0, 0, "09000064852b4f4f"], ["FDA-2021-N-0555-1168", "FDA", "FDA-2021-N-0555", "TAB A 2022-111 OTC Hearing Aids RIA as Submitted to OMB RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule", "Supporting & Related Material", "Background Material", "2022-09-06T04:00:00Z", 2022, 9, null, null, "2022-09-06T18:49:46Z", null, 0, 0, "09000064852b4f1a"], ["FDA-2021-N-0555-1172", "FDA", "FDA-2021-N-0555", "TAB C 2022-111 OTC Hearing Aids RIA as Cleared by OMB RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule", "Supporting & Related Material", "Background Material", "2022-09-06T04:00:00Z", 2022, 9, null, null, "2022-09-06T18:50:13Z", null, 0, 0, "09000064852b5038"], ["FDA-2021-N-0555-1166", "FDA", "FDA-2021-N-0555", "Memorandum to FDA DMS on OTC Hearing Aids Final Rule", "Other", "Memorandum", "2022-09-06T04:00:00Z", 2022, 9, "2022-09-06T04:00:00Z", null, "2022-09-06T18:47:29Z", null, 0, 0, "09000064852b4807"], ["FDA-2021-N-0555-1164", "FDA", "FDA-2021-N-0555", "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", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:42:33Z", null, 0, 0, "0900006485247a41"], ["FDA-2021-N-0555-1148", "FDA", "FDA-2021-N-0555", "RIA Reference 1 - The Big Six Hearing Aid Companies RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:01Z", null, 0, 0, "09000064852479be"], ["FDA-2021-N-0555-1132", "FDA", "FDA-2021-N-0555", "Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Rule", "Final Rule", "2022-08-17T04:00:00Z", 2022, 8, "2022-08-17T04:00:00Z", null, "2022-08-17T13:33:48Z", "2022-17230", 0, 0, "09000064852454dd"], ["FDA-2021-N-0555-1134", "FDA", "FDA-2021-N-0555", "Reference 1 - Hearing Loss Prevalence in the US RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:39:36Z", null, 0, 0, "0900006485247969"], ["FDA-2021-N-0555-1136", "FDA", "FDA-2021-N-0555", "Reference 3 - NIH Fact Sheet - Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:39:53Z", null, 0, 0, "090000648524796d"], ["FDA-2021-N-0555-1142", "FDA", "FDA-2021-N-0555", "Reference 9 - Occupational Noise Exposure NIOSH 98-126 RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:27Z", null, 0, 0, "090000648524798f"], ["FDA-2021-N-0555-1155", "FDA", "FDA-2021-N-0555", "Environmental Assessment FONSI RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:38Z", null, 0, 0, "09000064852479f8"], ["FDA-2021-N-0555-1141", "FDA", "FDA-2021-N-0555", "Reference 8 - ANSI-CTA 2051 2017 (FINAL) RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:22Z", null, 0, 0, "090000648524798b"], ["FDA-2021-N-0555-1146", "FDA", "FDA-2021-N-0555", "Reference 13 - New HRCT-Based Measurements of Human Ear Canal RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:49Z", null, 0, 0, "09000064852479ba"], ["FDA-2021-N-0555-1165", "FDA", "FDA-2021-N-0555", "EA Reference 14 - FN - Duracell Hearing Aid Batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:42:38Z", null, 0, 0, "0900006485247a42"], ["FDA-2021-N-0555-1133", "FDA", "FDA-2021-N-0555", "List of References (Final Rule) RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:39:15Z", null, 0, 0, "0900006485247968"], ["FDA-2021-N-0555-1145", "FDA", "FDA-2021-N-0555", "Reference 12 - External Auditory Canal Measurements RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:43Z", null, 0, 0, "09000064852479b9"], ["FDA-2021-N-0555-1149", "FDA", "FDA-2021-N-0555", "RIA Reference 2 - 20Q - 25 Years of MarkeTrak RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:07Z", null, 0, 0, "09000064852479bf"], ["FDA-2021-N-0555-1137", "FDA", "FDA-2021-N-0555", "Reference 4 - Longitudinal Relationship Between Hearing Aid Use and Cognitive Function in Older Americans RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:39:59Z", null, 0, 0, "090000648524796f"], ["FDA-2021-N-0555-1143", "FDA", "FDA-2021-N-0555", "Reference 10 - Safety Limit Warning Levels RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:32Z", null, 0, 0, "0900006485247991"], ["FDA-2021-N-0555-1150", "FDA", "FDA-2021-N-0555", "RIA Reference 3 - Online Shopping and E-Commerce RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:12Z", null, 0, 0, "09000064852479c0"], ["FDA-2021-N-0555-1152", "FDA", "FDA-2021-N-0555", "RIA Reference 5 - How Long Do Hearing Aids Last RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:22Z", null, 0, 0, "09000064852479f5"], ["FDA-2021-N-0555-1154", "FDA", "FDA-2021-N-0555", "RIA Reference 8 - NAICS 325400 \u2013 Pharmaceutical and Medical Manufacturing RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:33Z", null, 0, 0, "09000064852479f7"], ["FDA-2021-N-0555-1144", "FDA", "FDA-2021-N-0555", "Reference 11 - Real World Evidence on Gain and Output Settings RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:38Z", null, 0, 0, "09000064852479b8"], ["FDA-2021-N-0555-1153", "FDA", "FDA-2021-N-0555", "RIA Reference 7 - FDA Labeling Cost Model RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:27Z", null, 0, 0, "09000064852479f6"], ["FDA-2021-N-0555-1158", "FDA", "FDA-2021-N-0555", "EA Reference 7 - FN - Universal Waste RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:42:00Z", null, 0, 0, "09000064852479fb"], ["FDA-2021-N-0555-1160", "FDA", "FDA-2021-N-0555", "EA Reference 9 - FN - What are the benefits of rechargeable batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:42:11Z", null, 0, 0, "09000064852479fd"], ["FDA-2021-N-0555-1139", "FDA", "FDA-2021-N-0555", "Reference 6 - Why do people fitted with hearing aids not wear them RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:10Z", null, 0, 0, "0900006485247988"], ["FDA-2021-N-0555-1157", "FDA", "FDA-2021-N-0555", "EA Reference 5 - Advancing Sustainable Materials Management RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:54Z", null, 0, 0, "09000064852479fa"], ["FDA-2021-N-0555-1159", "FDA", "FDA-2021-N-0555", "EA Reference 8 - FN - Mercury in Batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:42:06Z", null, 0, 0, "09000064852479fc"], ["FDA-2021-N-0555-1151", "FDA", "FDA-2021-N-0555", "RIA Reference 4 - MarkeTrak VIII - 25-Year Trends in the Hearing Health Market RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:17Z", null, 0, 0, "09000064852479c1"], ["FDA-2021-N-0555-1162", "FDA", "FDA-2021-N-0555", "EA Reference 11 - FN - FAQ About Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:42:21Z", null, 0, 0, "0900006485247a3e"], ["FDA-2021-N-0555-1161", "FDA", "FDA-2021-N-0555", "EA Reference 10 - FN - How Long Do Hearing Aid Batteries Last RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:42:16Z", null, 0, 0, "09000064852479fe"], ["FDA-2021-N-0555-1163", "FDA", "FDA-2021-N-0555", "EA Reference 12 - FN - Hearing Loss and Hearing Aid Use Infographic RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:42:27Z", null, 0, 0, "0900006485247a40"], ["FDA-2021-N-0555-1138", "FDA", "FDA-2021-N-0555", "Reference 5 - Can Hearing Aids Delay Time to Diagnosis of Dementia etc RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:05Z", null, 0, 0, "0900006485247970"], ["FDA-2021-N-0555-1140", "FDA", "FDA-2021-N-0555", "Reference 7 - Hearing Health Care for Adults Priorities for Improving Access and Affordability RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:15Z", null, 0, 0, "0900006485247989"], ["FDA-2021-N-0555-1147", "FDA", "FDA-2021-N-0555", "Reference 16 - Regulatory Impact Analysis RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:40:55Z", null, 0, 0, "09000064852479bb"], ["FDA-2021-N-0555-1156", "FDA", "FDA-2021-N-0555", "EA Reference 4 - Electronic Waste Management Approaches RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:41:44Z", null, 0, 0, "09000064852479f9"], ["FDA-2021-N-0555-1135", "FDA", "FDA-2021-N-0555", "Reference 2 - Impact of Hearing Loss on Quality of Life in Older Adults RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2022-08-17T04:00:00Z", 2022, 8, null, null, "2022-08-17T17:39:47Z", null, 0, 0, "090000648524796b"], ["FDA-2021-N-0555-0137", "FDA", "FDA-2021-N-0555", "EA Reference 14 - FN - Duracell Hearing Aid Batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:55:05Z", null, 0, 0, "0900006484e06a42"], ["FDA-2021-N-0555-0140", "FDA", "FDA-2021-N-0555", "EA Reference 7 - FN - Universal Waste RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:55:26Z", null, 0, 0, "0900006484e06a45"], ["FDA-2021-N-0555-0143", "FDA", "FDA-2021-N-0555", "PRIA Reference 6 - FDA Labeling Cost Model RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:55:50Z", null, 0, 0, "0900006484e06a48"], ["FDA-2021-N-0555-0145", "FDA", "FDA-2021-N-0555", "EA Reference 9 - FN - What are the benefits of rechargeable batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:56:02Z", null, 0, 0, "0900006484e06a4a"], ["FDA-2021-N-0555-0127", "FDA", "FDA-2021-N-0555", "List of References RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:51:41Z", null, 0, 0, "0900006484e04e62"], ["FDA-2021-N-0555-0138", "FDA", "FDA-2021-N-0555", "PRIA Reference 3 - Online Shopping and E-Commerce RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:55:12Z", null, 0, 0, "0900006484e06a43"], ["FDA-2021-N-0555-0141", "FDA", "FDA-2021-N-0555", "Proposed FONSI Environmental Assessment RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:55:32Z", null, 0, 0, "0900006484e06a46"], ["FDA-2021-N-0555-0135", "FDA", "FDA-2021-N-0555", "EA Reference 4 - Electronic Waste Management Approaches RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:54:51Z", null, 0, 0, "0900006484e04e6a"], ["FDA-2021-N-0555-0132", "FDA", "FDA-2021-N-0555", "Reference 15 - Presentation on the Work of the CTA PSAP Standard Committee RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:54:07Z", null, 0, 0, "0900006484e04e67"], ["FDA-2021-N-0555-0136", "FDA", "FDA-2021-N-0555", "EA Reference 8 - FN - Mercury in Batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:54:58Z", null, 0, 0, "0900006484e06a41"], ["FDA-2021-N-0555-0134", "FDA", "FDA-2021-N-0555", "EA Reference 12 - FN - Hearing Loss and Hearing Aid Use Infographic RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:54:20Z", null, 0, 0, "0900006484e04e69"], ["FDA-2021-N-0555-0148", "FDA", "FDA-2021-N-0555", "EA Reference 5 - Advancing Sustainable Materials Management RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:56:25Z", null, 0, 0, "0900006484e06a4d"], ["FDA-2021-N-0555-0129", "FDA", "FDA-2021-N-0555", "Reference 10 - HLAA Response to Call for Comment RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:53:46Z", null, 0, 0, "0900006484e04e64"], ["FDA-2021-N-0555-0139", "FDA", "FDA-2021-N-0555", "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", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:55:19Z", null, 0, 0, "0900006484e06a44"], ["FDA-2021-N-0555-0130", "FDA", "FDA-2021-N-0555", "Reference 8 - Conditions for Sale for Air-Conduction Hearing Aids IIE Guidance RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:53:54Z", null, 0, 0, "0900006484e04e65"], ["FDA-2021-N-0555-0133", "FDA", "FDA-2021-N-0555", "EA Reference 11 - FN - FAQ About Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:54:14Z", null, 0, 0, "0900006484e04e68"], ["FDA-2021-N-0555-0131", "FDA", "FDA-2021-N-0555", "PRIA Reference 4 - How Long Do Hearing Aids Last RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:54:01Z", null, 0, 0, "0900006484e04e66"], ["FDA-2021-N-0555-0146", "FDA", "FDA-2021-N-0555", "Reference 16 - The Potential Risk of Using PSAPs RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:56:08Z", null, 0, 0, "0900006484e06a4b"], ["FDA-2021-N-0555-0128", "FDA", "FDA-2021-N-0555", "Reference 23 - PRIA for OTC Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:51:47Z", null, 0, 0, "0900006484e04e63"], ["FDA-2021-N-0555-0142", "FDA", "FDA-2021-N-0555", "EA Reference 10 - FN - How Long Do Hearing Aid Batteries Last RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:55:43Z", null, 0, 0, "0900006484e06a47"], ["FDA-2021-N-0555-0149", "FDA", "FDA-2021-N-0555", "PRIA Reference 7 - NAICS 325400 Pharmaceutical and Medical Manufacturing RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:56:33Z", null, 0, 0, "0900006484e06a4e"], ["FDA-2021-N-0555-0144", "FDA", "FDA-2021-N-0555", "PRIA Reference 1 - The Big Six Hearing Aid Companies RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:55:56Z", null, 0, 0, "0900006484e06a49"], ["FDA-2021-N-0555-0147", "FDA", "FDA-2021-N-0555", "PRIA Reference 2 - 20Q - 25 Years of MarkeTrak RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-11-02T04:00:00Z", 2021, 11, null, null, "2021-11-02T13:56:18Z", null, 0, 0, "0900006484e06a4c"], ["FDA-2021-N-0555-0003", "FDA", "FDA-2021-N-0555", "Reference 2 - Impact of Hearing Loss on Quality of Life in Older Adults RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:45:16Z", null, 0, 0, "0900006484dcec41"], ["FDA-2021-N-0555-0010", "FDA", "FDA-2021-N-0555", "Reference 20 - NASEM Committee Looks at Regulation for OTC Hearing Devices RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:46:17Z", null, 0, 0, "0900006484dcec40"], ["FDA-2021-N-0555-0006", "FDA", "FDA-2021-N-0555", "Reference 4 - Why do people fitted with hearing aids not wear them RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:45:43Z", null, 0, 0, "0900006484dcec42"], ["FDA-2021-N-0555-0008", "FDA", "FDA-2021-N-0555", "Reference 13 - ANSI-CTA 2051 2017 (FINAL) RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:46:00Z", null, 0, 0, "0900006484dcec43"], ["FDA-2021-N-0555-0012", "FDA", "FDA-2021-N-0555", "Reference 22 - PSAPs v Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:46:57Z", null, 0, 0, "0900006484dcfbd7"], ["FDA-2021-N-0555-0011", "FDA", "FDA-2021-N-0555", "Reference 21 - The Compression Handbook RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:46:25Z", null, 0, 0, "0900006484dcfbd8"], ["FDA-2021-N-0555-0002", "FDA", "FDA-2021-N-0555", "Reference 1 - Hearing Loss Prevalence in the US RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:44:58Z", null, 0, 0, "0900006484dcec3f"], ["FDA-2021-N-0555-0005", "FDA", "FDA-2021-N-0555", "Reference 3b - Can Hearing Aids Delay Time to Diagnosis of Dementia etc RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:45:35Z", null, 0, 0, "0900006484dcfbd6"], ["FDA-2021-N-0555-0009", "FDA", "FDA-2021-N-0555", "Reference 18 - Theoretical and Practical Considerations in Compression Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:46:08Z", null, 0, 0, "0900006484dcfbd9"], ["FDA-2021-N-0555-0007", "FDA", "FDA-2021-N-0555", "Reference 6 - Hearing Health Care for Adults Priorities for Improving Access and Affordability RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:45:52Z", null, 0, 0, "0900006484dcfbda"], ["FDA-2021-N-0555-0004", "FDA", "FDA-2021-N-0555", "Reference 3a - Longitudinal Relationship Between Hearing Aid Use and Cognitive Function in Older Americans RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Supporting & Related Material", "Background Material", "2021-10-21T04:00:00Z", 2021, 10, null, null, "2021-11-02T13:45:25Z", null, 0, 0, "0900006484dcfbd5"], ["FDA-2021-N-0555-0001", "FDA", "FDA-2021-N-0555", "Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids", "Proposed Rule", "Advance Notice of Proposed Rulemaking (ANPRM)", "2021-10-20T04:00:00Z", 2021, 10, "2021-10-20T04:00:00Z", "2022-01-19T04:59:59Z", "2022-09-19T18:22:50Z", "2021-22473", 0, 0, "0900006484dceaeb"]], "truncated": false, "filtered_table_rows_count": 77, "expanded_columns": [], "expandable_columns": [[{"column": "docket_id", "other_table": "dockets", "other_column": "id"}, "title"]], "columns": ["id", "agency_id", "docket_id", "title", "document_type", "subtype", "posted_date", "posted_year", "posted_month", "comment_start_date", "comment_end_date", "last_modified", "fr_doc_num", "open_for_comment", "withdrawn", "object_id"], "primary_keys": ["id"], "units": {}, "query": {"sql": "select id, agency_id, docket_id, title, document_type, subtype, posted_date, posted_year, posted_month, comment_start_date, comment_end_date, last_modified, fr_doc_num, open_for_comment, withdrawn, object_id from documents where \"docket_id\" = :p0 order by posted_date desc limit 101", "params": {"p0": "FDA-2021-N-0555"}}, "facet_results": {"agency_id": {"name": "agency_id", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-2021-N-0555", "results": [{"value": "FDA", "label": "FDA", "count": 77, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&agency_id=FDA", "selected": false}], "truncated": false}, "document_type": {"name": "document_type", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-2021-N-0555", "results": [{"value": "Supporting & Related Material", "label": "Supporting & Related Material", "count": 73, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&document_type=Supporting+%26+Related+Material", "selected": false}, {"value": "Notice", "label": "Notice", "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&document_type=Notice", "selected": false}, {"value": "Other", "label": "Other", "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&document_type=Other", "selected": false}, {"value": "Proposed Rule", "label": "Proposed Rule", "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&document_type=Proposed+Rule", "selected": false}, {"value": "Rule", "label": "Rule", "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&document_type=Rule", "selected": false}], "truncated": false}, "posted_year": {"name": "posted_year", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-2021-N-0555", "results": [{"value": 2022, "label": 2022, "count": 42, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&posted_year=2022", "selected": false}, {"value": 2021, "label": 2021, "count": 35, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&posted_year=2021", "selected": false}], "truncated": false}}, "suggested_facets": [{"name": "subtype", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&_facet=subtype"}, {"name": "posted_date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&_facet=posted_date"}, {"name": "posted_month", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&_facet=posted_month"}, {"name": "posted_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&_facet_date=posted_date"}, {"name": "comment_start_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&_facet_date=comment_start_date"}, {"name": "comment_end_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&_facet_date=comment_end_date"}, {"name": "last_modified", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0555&_facet_date=last_modified"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 254.83413692563772, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}