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77 rows where docket_id = "FDA-2021-N-0555" sorted by posted_date descending
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document_type 5
- Supporting & Related Material 73
- Notice 1
- Other 1
- Proposed Rule 1
- Rule 1
agency_id 1
- FDA 77
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 |
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