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withdrawn,object_id
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,,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,,,2022-09-06T18:49:53Z,,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,,,2022-09-06T18:49:59Z,,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,,,2022-09-06T18:49:37Z,,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,,,2022-09-06T18:50:06Z,,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,,,2022-09-06T18:49:46Z,,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,,,2022-09-06T18:50:13Z,,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,,2022-09-06T18:47:29Z,,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,,,2022-08-17T17:42:33Z,,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,,,2022-08-17T17:41:01Z,,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,,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,,,2022-08-17T17:39:36Z,,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,,,2022-08-17T17:39:53Z,,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,,,2022-08-17T17:40:27Z,,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,,,2022-08-17T17:41:38Z,,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,,,2022-08-17T17:40:22Z,,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,,,2022-08-17T17:40:49Z,,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,,,2022-08-17T17:42:38Z,,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,,,2022-08-17T17:39:15Z,,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,,,2022-08-17T17:40:43Z,,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,,,2022-08-17T17:41:07Z,,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,,,2022-08-17T17:39:59Z,,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,,,2022-08-17T17:40:32Z,,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,,,2022-08-17T17:41:12Z,,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,,,2022-08-17T17:41:22Z,,0,0,09000064852479f5
FDA-2021-N-0555-1154,FDA,FDA-2021-N-0555,"RIA Reference 8 - 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,2022-08-17T04:00:00Z,2022,8,,,2022-08-17T17:41:33Z,,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,,,2022-08-17T17:40:38Z,,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,,,2022-08-17T17:41:27Z,,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,,,2022-08-17T17:42:00Z,,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,,,2022-08-17T17:42:11Z,,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,,,2022-08-17T17:40:10Z,,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,,,2022-08-17T17:41:54Z,,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,,,2022-08-17T17:42:06Z,,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,,,2022-08-17T17:41:17Z,,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,,,2022-08-17T17:42:21Z,,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,,,2022-08-17T17:42:16Z,,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,,,2022-08-17T17:42:27Z,,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,,,2022-08-17T17:40:05Z,,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,,,2022-08-17T17:40:15Z,,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,,,2022-08-17T17:40:55Z,,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,,,2022-08-17T17:41:44Z,,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,,,2022-08-17T17:39:47Z,,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,,,2021-11-02T13:55:05Z,,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,,,2021-11-02T13:55:26Z,,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,,,2021-11-02T13:55:50Z,,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,,,2021-11-02T13:56:02Z,,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,,,2021-11-02T13:51:41Z,,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,,,2021-11-02T13:55:12Z,,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,,,2021-11-02T13:55:32Z,,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,,,2021-11-02T13:54:51Z,,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,,,2021-11-02T13:54:07Z,,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,,,2021-11-02T13:54:58Z,,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,,,2021-11-02T13:54:20Z,,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,,,2021-11-02T13:56:25Z,,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,,,2021-11-02T13:53:46Z,,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,,,2021-11-02T13:55:19Z,,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,,,2021-11-02T13:53:54Z,,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,,,2021-11-02T13:54:14Z,,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,,,2021-11-02T13:54:01Z,,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,,,2021-11-02T13:56:08Z,,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,,,2021-11-02T13:51:47Z,,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,,,2021-11-02T13:55:43Z,,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,,,2021-11-02T13:56:33Z,,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,,,2021-11-02T13:55:56Z,,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,,,2021-11-02T13:56:18Z,,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,,,2021-11-02T13:45:16Z,,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,,,2021-11-02T13:46:17Z,,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,,,2021-11-02T13:45:43Z,,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,,,2021-11-02T13:46:00Z,,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,,,2021-11-02T13:46:57Z,,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,,,2021-11-02T13:46:25Z,,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,,,2021-11-02T13:44:58Z,,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,,,2021-11-02T13:45:35Z,,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,,,2021-11-02T13:46:08Z,,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,,,2021-11-02T13:45:52Z,,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,,,2021-11-02T13:45:25Z,,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