3.0.0 1652 2023-01-11T13:35:34Z 2023-01-11T13:35:34Z House HR 2017-03-21 115 [Congressional Record Volume 163, Number 49 (Tuesday, March 21, 2017)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. KENNEDY:H.R. 1652.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8--to provide for the general welfareand to regulate commerce among the states.[Page H2288]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2017-03-24T17:43:31Z Referred to 2017-03-21T14:03:15Z Over-the-Counter Hearing Aid Act of 2017 115 670 S 2017-03-21 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS FDA Reauthorization Act of 2017 115 934 S 2017-05-11 Placed on Senate Legislative Calendar under General Orders. Calendar No. 76. Related bill CRS FDA Reauthorization Act of 2017 115 2430 HR 2017-08-18 Signed by President. Related bill CRS 2017-03-24 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2017-03-21 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2017-03-21 Introduced in House IntroReferral Intro-H 9 Library of Congress 2017-03-21 Introduced in House IntroReferral 1000 9 Library of Congress K000379 Rep. Kennedy, Joseph P., III [D-MA-4] Joseph Kennedy D MA P. 4 N C001103 Rep. Carter, Earl L. "Buddy" [R-GA-1] Earl Carter R GA L. "Buddy" 1 2017-03-21 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2017-03-21 True B001298 Rep. Bacon, Don [R-NE-2] Don Bacon R NE 2 2017-04-06 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2017-04-20 False M000312 Rep. McGovern, James P. [D-MA-2] JAMES MCGOVERN D MA P. 2 2017-04-20 False T000465 Rep. Tsongas, Niki [D-MA-3] Niki Tsongas D MA 3 2017-04-20 False P000258 Rep. Peterson, Collin C. [D-MN-7] COLLIN PETERSON D MN C. 7 2017-04-27 False D000624 Rep. Dingell, Debbie [D-MI-12] Debbie Dingell D MI 12 2017-04-27 False C001067 Rep. Clarke, Yvette D. [D-NY-9] Yvette Clarke D NY D. 9 2017-05-16 False S001170 Rep. Shea-Porter, Carol [D-NH-1] Carol Shea-Porter D NH 1 2017-05-16 False L000397 Rep. Lofgren, Zoe [D-CA-19] ZOE LOFGREN D CA 19 2017-05-17 False B001260 Rep. Buchanan, Vern [R-FL-16] Vern Buchanan R FL 16 2017-06-07 False H001038 Rep. Higgins, Brian [D-NY-26] Brian Higgins D NY 26 2017-06-15 False R000606 Rep. Raskin, Jamie [D-MD-8] Jamie Raskin D MD 8 2017-06-20 False Health Administrative law and regulatory procedures Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Hearing, speech, and vision care Marketing and advertising Health 00 2017-03-21 Introduced in House 2017-07-13T17:36:32Z Over-the-Counter Hearing Aid Act of 2017

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.

State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids.

The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices.

]]> Over-the-Counter Hearing Aid Act of 2017 Display Title Over-the-Counter Hearing Aid Act of 2017 Official Title as Introduced To provide for the regulation of over-the-counter hearing aids. Introduced in House IH Short Titles as Introduced Over-the-Counter Hearing Aid Act of 2017 Introduced in House 2017-03-21T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr1652ih/xml/BILLS-115hr1652ih.xml 2017-03-24 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.