US Congressman Marsha Blackburn -> Over-the-Counter Hearing Aid Act

Congressman Diane Black -- @ Hoax and Change

US Congressman Marsha Blackburn -> Over-the-Counter Hearing Aid Act

This Week From Washington
Fellow Americans,

It was another busy week in Washington. From national defense to human trafficking we tackled a range of important issues in the House.

BUILDING TENNESSEE

Before coming to Washington this week, I had the opportunity to meet with Tennessee’s builders and contractors. In addition to being honored with the Champion of the Merit Shop Award, we discussed many of the issues facing our builders today, what is going on in Tennessee. Additionally, I spent time answering their questions and talking about some of the things we are working on in Washington.

VOICES FROM BOTH SIDES

This week, Frank Luntz invited 12 House and Senate members known for seeking both bi-partisanship and solutions from the House and Senate, Republican and Democrat, to participate in one of his legendary focus groups. Frank moderated a discussion on everything from tax reform to healthcare to government spending to civility. It was a good discussion and well worth the watch if you didn’t catch it on CBS earlier today.

(click to watch)

THEY DESERVE IT

Today, we passed our annual defense authorization bill, the National Defense Authorization Act. This is our annual bill to establish funding levels for national defense-related activity. We have a profound obligation to provide for the common defense. It is our job to ensure those who selflessly serve have the tools and resources they need to keep Americans safe. For those soldiers and their families at Fort Campbell, this bill is a big win, helping relieve shortfalls in personnel, funding, and resources that have strained operations and morale for several years. I am pleased to see this bill pass and hopeful the Senate will take quick action on it.

Passage of this bill represents the first step of the Trump administration to rebuild our nation’s military. I will continue working in the House to make sure those who serve have the resources, training, and certainty they need to keep us safe. Click here to read my column on passage of the bill.

AS LONG AS IT TAKES

As you may have heard in the news, Republicans in the Senate are staying in Washington for at least two more weeks this summer to keep working on important issues such as healthcare, tax reform, and spending. I assure you, many of us in the House are ready and willing to do the same and as the Senate sends bills to us, we will be back in Washington to get your priorities across the finish line. I spoke with Stu Varney on Fox Business this week about staying as long as it takes to keep our promises to you.

(click to watch)

#TN7inDC

It is always a pleasure having friends, neighbors, and constituents visit us in the office in D.C. We enjoyed having each and every one of you in our office this week and we hope your trip to Washington was enjoyable. You are always welcome!

If you are planning a trip to DC, let us know…we can help.

TURNING UP THE VOLUME

I was particularly thrilled this week to see my Over-the-Counter Hearing Aid Act passed as part of the FDA reauthorization measure we passed in the House. This bill would allow certain types of hearing aids to be defined as over-the-counter (OTC) for Americans who suffer with mild to moderate hearing impairment, making them cheaper and more available. For the roughly 48 million Americans suffering from hearing loss, this bill could change lives:

(click to watch)

 

 

PRESS RELEASE

Blackburn-sponsored bill making hearing aids affordable, accessible advances

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Washington, June 7, 2017 0 comments
WASHINGTON – Reps. Marsha Blackburn (R-Tenn.) and Joe Kennedy III (D-Mass.) on Wednesday applauded the bipartisan passage of their Over-the-Counter Hearing Aid Act in the House Energy & Commerce Committee. The legislation would make certain types of hearing aids available over-the-counter to Americans with mild to moderate hearing loss.

“This legislation is the first step to ensuring that millions of Americans can finally have access to affordable hearing aids,” said Rep. Marsha Blackburn. “Just as someone can correct minor sight loss by purchasing reading glasses from their local pharmacy, so too should they be able to correct minor hearing loss with an affordable and accessible hearing aid. This is a bipartisan, common-sense solution the people want and need.”

 

“Access to hearing aids shouldn’t be limited by cost and a lack of competition. Recent innovation in hearing aid technology and over-the-counter sales will ensure millions of Americans are able to obtain hearing aids that improve their ability to communicate with their families, at their jobs and everywhere in between. With today’s bipartisan passage, we have moved closer to bringing relief to millions of our neighbors. I look forward to continued bipartisan efforts to move this bill through the full House and Senate,” said Rep. Joe Kennedy III.

In addition to greater accessibility, the proposed legislation would require the FDA to write regulations ensuring that this new category of OTC hearing aids meets the same high standards for safety, consumer labeling and manufacturing protections as medical devices, providing consumers the option of an FDA-regulated device at lower cost.

The provisions of the Over-the-Counter Hearing Aid Act implement major recommendations from the President’s Council of Advisors on Science and Technology and the National Academies of Science, Engineering, and Medicine. The legislation has received endorsements from AARP, the Gerontological Society of America, the Academy of Doctors of Audiology, and the Hearing Loss Association of America.

Nearly 30 million Americans experience age-related hearing loss, including over half of adults between the ages of 70 to 79. Yet only a small share of Americans with hearing loss – around 14 percent – use hearing aids, primarily due to their high cost. Hearing aids are not covered by Medicare or most private insurance plans, and out-of-pocket costs for a single hearing aid average $2,400 – far out of reach for many consumers.

The Over-the-Counter Hearing Aid Act of 2017 Approximately 30 million Americans experience age-related hearing loss, including over half of adults between the ages 70-79. 1 Yet only a small share of Americans with hearing loss – around 14 percent – use assistive hearing technologies, primarily because they cannot afford to buy costly hearing aids. 2 Hearing aids are not covered by Medicare or most private insurance plans, and out-of-pocket costs for a single hearing aid average $2,400 – far out of reach for many consumers.3 As a result, individuals living in poverty are substantially less likely to have access to hearing aids than those with higher incomes.4 Complex hearing aid regulations exacerbate this problem by restricting the availability of hearing aids. In 1977, the FDA imposed a set of special regulations on hearing aids, including a requirement that individuals obtain a medical evaluation or sign a waiver of that evaluation before being allowed to purchase or use a hearing aid. After an extensive review, the National Academies of Sciences, Engineering, and Medicine found “no evidence that the required medical evaluation or waiver of that evaluation provides any clinically meaningful benefit” and recommended “removing this regulation to serve consumers’ best interests.”5 Both the National Academies and the President’s Council of Advisors on Science and Technology (PCAST) have also recommended making some types of hearing aids available over the counter – similar to the way in which basic reading glasses are available without a prescription. PCAST’s analysis of the hearing aid market concluded that “consumers find it difficult to shop for the best value.”6 Hearing aids are typically sold “bundled” with fees charged for evaluation, follow-up, and adjustments to the device, even though many consumers never use these services.7 Allowing hearing aids to be sold over the counter will expand consumer choice, open the market to innovative hearing technologies, and drive down prices so that millions more Americans can access affordable hearing aids. The Over-the-Counter Hearing Aid Act of 2017 The Over-the-Counter Hearing Aid Act of 2017 implements recommendations from PCAST and the National Academies to help the millions of Americans affected by hearing impairment. The Act: • Makes certain types of hearing aids – those intended to be used by adults to compensate for perceived mild to moderate hearing impairment – available over the counter. • Removes an unnecessary and burdensome requirement that consumers obtain a medical evaluation or sign a waiver of that examination in order to obtain an OTC hearing aid. • Requires the FDA to issue regulations containing safety and labeling requirements for this new category of OTC hearing aids. • Maintains existing safety, labeling, and manufacturing protections and applies them to OTC devices in order to ensure that OTC hearing aids are held to the same high standards as other medical devices. • Requires the FDA to update its draft guidance on Personal Sound Amplification Products (PSAPs), consumer electronics products that may use similar technology to hearing aids, but are intended for use by individuals with normal hearing. 1 Frank R. Lin, John K. Niparko, and Luigi Ferrucci. 2011. “Hearing Loss Prevalence in the United States,” Archives of Internal Medicine 171: 1851-1853 (online at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564588/). 2 National Academies of Sciences, Engineering, and Medicine. 2016. Hearing Health Care for Adults: Priorities for Improving Access and Affordability. Washington, DC: The National Academies Press (online at: http://www.nationalacademies.org/hmd/Reports/2016/Hearing-Health-Care-for-Adults.aspx), p. 183. 3 President’s Council of Advisors on Science and Technology, Aging America and Hearing Loss: Imperative of Improved Hearing Technologies (October 2015) (online at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_hearing_tech_letterreport_final.pdf), p. 1. National Academies of Sciences, Engineering, and Medicine. 2016. Hearing Health Care for Adults: Priorities for Improving Access and Affordability. Washington, DC: The National Academies Press (online at: http://www.nationalacademies.org/hmd/Reports/2016/Hearing-Health-Care-for-Adults.aspx), p. 21-22. Sergei Kochkin. 2007. “MarkeTrak VII: Obstacles to Adult Non-User Adoption of Hearing Aids,” The Hearing Journal 60: 24-50 (online at: http://www.betterhearing.org/sites/default/files/hearingpediaresources/MarkeTrak%20VII%20Obstacles%20to%20adult%20nonuser%20adoption%20of%20hearing%20aids.pdf). Karl E. Strom. 2014. “HR 2013 Hearing Aid Dispenser Survey: Dispensing in the Age of Internet and Big Box Retailers,” The Hearing Review 21 (4): 22-28 (online at: http://www.hearingreview.com/2014/04/hr-2013-hearing-aid-dispenser-survey-dispensing-age-internet-big-boxretailers-comparison-present-past-key-business-indicators-dispensing-offices/). 4 Kathleen E. Bainbridge and Virginia Ramachandran. 2014. “Hearing Aid Use among Older United States Adults: The National Health and Nutrition Examination Survey, 2005-2006 and 2009-2010,” Ear and Hearing 35: 289-294. 5 National Academies of Sciences, Engineering, and Medicine. 2016. Hearing Health Care for Adults: Priorities for Improving Access and Affordability. Washington, DC: The National Academies Press (online at: http://www.nationalacademies.org/hmd/Reports/2016/Hearing-Health-Care-for-Adults.aspx), p. 120-121. 6 President’s Council of Advisors on Science and Technology, Aging America and Hearing Loss: Imperative of Improved Hearing Technologies (October 2015) (online at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_hearing_tech_letterreport_final.pdf), p. 3. 7 Karl E. Strom. 2014. “HR 2013 Hearing Aid Dispenser Survey: Dispensing in the Age of Internet and Big Box Retailers,” The Hearing Review 21 (4): 22-28 (online at: http://www.hearingreview.com/2014/04/hr-2013-hearingaid-dispenser-survey-dispensing-age-internet-big-box-retailers-comparison-present-past-key-business-indicatorsdispensing-offices/). National Academies of Sciences, Engineering, and Medicine. 2016. Hearing Health Care for Adults: Priorities for Improving Access and Affordability. Washington, DC: The National Academies Press (online at: http://www.nationalacademies.org/hmd/Reports/2016/Hearing-Health-Care-for-Adults.aspx), p. 242-243, 258- 259. Consumer Reports, “How to Buy a Hearing Aid” (July 2009) (online at: http://www.consumerreports.org/cro/magazine-archive/july-2009/health/hearing-aids/how-to-buy-a-hearingaid/hearing-aids-how-to-buy-a-hearing-aid.htm).

 

 

TAM17679 S.L.C. 115TH CONGRESS 1ST SESSION S. ll To provide for the regulation of over-the-counter hearing aids. IN THE SENATE OF THE UNITED STATES llllllllll Ms. WARREN (for herself, Mr. GRASSLEY, Ms. HASSAN, and Mr. ISAKSON) introduced the following bill; which was read twice and referred to the Committee on llllllllll A BILL To provide for the regulation of over-the-counter hearing aids. 1 Be it enacted by the Senate and House of Representa- 2 tives of the United States of America in Congress assembled, 3 SECTION 1. SHORT TITLE. 4 This Act may be cited as the ‘‘Over-the-Counter 5 Hearing Aid Act of 2017’’. 6 SEC. 2. REGULATION OF OVER-THE-COUNTER HEARING 7 AIDS. 8 (a) IN GENERAL.—Section 520 of the Federal Food, 9 Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by 10 adding at the end the following: 2 TAM17679 S.L.C. 1 ‘‘(p) REGULATION OF OVER-THE-COUNTER HEARING 2 AIDS.— 3 ‘‘(1) DEFINITION.—In this subsection, the term 4 ‘over-the-counter hearing aid’ means a device— 5 ‘‘(A) that uses the same fundamental sci- 6 entific technology as air conduction hearing 7 aids (as defined in section 874.3300 of title 21, 8 Code of Federal Regulations) (or any successor 9 regulation) or wireless air conduction hearing 10 aids (as defined in section 874.3305 of title 21, 11 Code of Federal Regulations) (or any successor 12 regulation); 13 ‘‘(B) that is intended to be used by adults 14 over the age of 18 to compensate for perceived 15 mild to moderate hearing impairment; 16 ‘‘(C) that, through tools, tests, or software, 17 allows the user to control the over-the-counter 18 hearing aid and customize it to the user’s hear- 19 ing needs; 20 ‘‘(D) that may— 21 ‘‘(i) use wireless technology; or 22 ‘‘(ii) include tests for self-assessment 23 of hearing loss; and 24 ‘‘(E) that is available over-the-counter, 25 without the supervision, prescription, or other 3 TAM17679 S.L.C. 1 order, involvement, or intervention of a licensed 2 person, to consumers through in-person trans- 3 actions, by mail, or online. 4 ‘‘(2) REGULATION.—An over-the-counter hear- 5 ing aid shall be subject to the regulations promul- 6 gated in accordance with section 2(b) of the Over- 7 the-Counter Hearing Aid Act of 2017 and shall be 8 exempt from sections 801.420 and 801.421 of title 9 21, Code of Federal Regulations (or any successor 10 regulations).’’. 11 (b) REGULATIONS TO ESTABLISH CATEGORY.— 12 (1) IN GENERAL.—The Secretary of Health and 13 Human Services (referred to in this section as the 14 ‘‘Secretary’’), not later than 3 years after the date 15 of enactment of this Act, shall promulgate proposed 16 regulations to establish a category of over-the- 17 counter hearing aids, as defined in subsection (p) of 18 section 520 of the Federal Food, Drug, and Cos- 19 metic Act (21 U.S.C. 360j) as amended by sub- 20 section (a), and, not later than 180 days after the 21 date on which the public comment period on the pro- 22 posed regulations closes, shall issue such final regu- 23 lations. 24 (2) REQUIREMENTS.—In promulgating the reg- 25 ulations under paragraph (1), the Secretary shall— 4 TAM17679 S.L.C. 1 (A) include requirements that provide rea- 2 sonable assurances of the safety and efficacy of 3 over-the-counter hearing aids; 4 (B) include requirements that establish or 5 adopt output limits appropriate for over-the- 6 counter hearing aids; 7 (C) include requirements for appropriate 8 labeling of the over-the-counter hearing aid, in- 9 cluding how consumers may report adverse 10 events, any conditions or contraindications, and 11 any advisements to consult promptly with a li- 12 censed physician; and 13 (D) describe the requirements under which 14 the sale of over-the-counter hearing aids is per- 15 mitted, without the supervision, prescription, or 16 other order, involvement, or intervention of a li- 17 censed person, to consumers through in-person 18 transactions, by mail, or online. 19 (3) PREMARKET NOTIFICATION.—The Sec- 20 retary shall make findings under section 510(m) of 21 the Federal Food, Drug, and Cosmetic Act (21 22 U.S.C. 360(m)) to determine whether over-the- 23 counter hearing aids (as defined in section 520(p) of 24 the Federal Food, Drug, and Cosmetic Act (21 25 U.S.C. 360j), as amended by subsection (a)) require 5 TAM17679 S.L.C. 1 a report under section 510(k) to provide reasonable 2 assurance of safety and effectiveness. 3 (4) EFFECT ON STATE LAW.—No State or local 4 government shall establish or continue in effect any 5 law, regulation, order, or other requirement specifi- 6 cally applicable to hearing products that would re- 7 strict or interfere with the servicing, marketing, sale, 8 dispensing, use, customer support, or distribution of 9 over-the-counter hearing aids (as defined in section 10 520(p) of the Federal Food, Drug, and Cosmetic 11 Act (21 U.S.C. 360j), as amended by subsection (a)) 12 through in-person transactions, by mail, or online, 13 that is different from, in addition to, or otherwise 14 not identical to, the regulations promulgated under 15 this subsection, including any State or local require- 16 ment for the supervision, prescription, or other 17 order, involvement, or intervention of a licensed per- 18 son for consumers to access over-the-counter hearing 19 aids. 20 (c) NEW GUIDANCE ISSUED.—Not later than the 21 date on which final regulations are issued under sub- 22 section (b), the Secretary shall update and finalize the 23 draft guidance of the Department of Health and Human 24 Services entitled, ‘‘Regulatory Requirements for Hearing 25 Aid Devices and Personal Sound Amplification Products’’, 6 TAM17679 S.L.C. 1 issued on November 7, 2013. Such updated and finalized 2 guidance shall clarify which products, on the basis of 3 claims or other marketing, advertising, or labeling mate- 4 rial, meet the definition of a device in section 201 of the 5 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) 6 and which products meet the definition of a personal 7 sound amplification product, as set forth in such guidance.

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