IntriCon Backs President's Signing of FDA Reauthorization Act into Law
August 22 2017 - 2:00PM
Business Wire
Legislation Includes Over-the-Counter
Hearing Aid Act of 2017
IntriCon Corporation (NASDAQ: IIN), a designer,
developer, manufacturer and distributor of miniature and
micro-miniature body-worn devices, announced that on Friday, August
18, 2017, President Donald Trump signed into law H.R. 2430, the
U.S. Food and Drug Administration (FDA) Reauthorization Act, which
includes the Over-the-Counter Hearing (OTC) Aid Act of 2017. The
legislation is designed to enable adults with mild- to
moderate-hearing loss to access OTC hearing aids without being seen
by a hearing care professional.
Said Mark S. Gorder, IntriCon’s president and chief executive
officer, “This is an important step forward in hearing health. The
OTC Hearing Aid Act is designed to provide greater public access to
OTC hearing aids at a lower cost. To reiterate, we believe that
this new law can remove the significant barriers existing today
that prevent innovative hearing health solutions. Moreover, we feel
that it will invigorate competition, spur innovation and facilitate
the development of an ecosystem of hearing healthcare that provides
affordable and accessible solutions to millions of unserved or
underserved Americans.”
The FDA Reauthorization Act, which was introduced in March by
Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), was
passed by the U.S. House on July 12, 2017, and the U.S. Senate on
August 3, 2017. It will require the FDA to create and regulate a
category of OTC hearing aids to ensure they meet the same high
standards for safety, consumer labeling, and manufacturing
protection that all other medical devices must meet.
Additionally, the OTC Hearing Aid Act mandates that the FDA
establish an OTC hearing aid category for adults with “perceived”
mild- to moderate-hearing loss within three years of passage of the
legislation. The FDA also must finalize a rule within 180 days
after the close of the comment period, detailing what level of
safety, labeling and consumer protections will be included.
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,
and 70 percent suffer hearing loss in both ears, increasing costs
to, on average, $4,800—far out of reach for many consumers.
Concluded Gorder, “By signing the OTC Hearing Aid Act into law,
we’ve entered a new era in hearing healthcare. IntriCon is at the
forefront and spearheading an effort to create innovative solutions
that provide greater hearing device access at a much lower cost for
millions of Americans.”
About IntriCon CorporationHeadquartered in Arden Hills,
Minn., IntriCon Corporation designs, develops, manufactures and
distributes miniature and micro-miniature body-worn devices. These
advanced products help medical, healthcare and professional
communications companies meet the rising demand for smaller, more
intelligent and better connected devices. IntriCon has facilities
in the United States, Asia, the United Kingdom and Europe. The
company’s common stock trades under the symbol “IIN” on the NASDAQ
Global Market. For more information about IntriCon, visit
www.intricon.com.
Forward-Looking StatementsStatements made in this release
and in IntriCon’s other public filings and releases that are not
historical facts or that include forward-looking terminology are
“forward-looking statements” within the meaning of the Securities
Exchange Act of 1934, as amended. These forward-looking statements
may be affected by known and unknown risks, uncertainties and other
factors that are beyond IntriCon’s control, and may cause
IntriCon’s actual results, performance or achievements to differ
materially from the results, performance and achievements expressed
or implied in the forward-looking statements. These risks,
uncertainties and other factors are detailed from time to time in
the company’s filings with the Securities and Exchange Commission,
including the Annual Report on Form 10-K for the year ended
December 31, 2016. The company disclaims any intent or obligation
to publicly update or revise any forward-looking statements,
regardless of whether new information becomes available, future
developments occur or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20170822006030/en/
IntriCon CorporationScott Longval, CFO,
651-604-9526slongval@intricon.comorPadillaMatt Sullivan,
612-455-1700matt.sullivan@padillaco.com
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