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35 rows where docket_id = "FDA-2021-N-0555" and posted_year = 2021 sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-0555-0137 | 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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CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;