IntriCon Supports U.S. Senate Passing FDA Reauthorization Act
August 03 2017 - 5:04PM
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 the U.S. Senate
today passed (94-1) H.R. 2430, the U.S. Food and Drug
Administration (FDA) Reauthorization Act, which includes the
Over-the-Counter Hearing Aid Act of 2017. On July 12, the House of
Representatives passed H.R. 2430 by voice vote. The bill now heads
to the White House for President Trump’s signature.
The legislation will make hearing aids available over the
counter for those with mild to moderate hearing loss. It will also
require the FDA to write regulations ensuring that this new
category of over-the-counter hearing aids meets the same high
standards for safety, consumer labeling and manufacturing
protections as all medical devices, providing consumers the option
of an FDA-regulated device at lower cost.
Said Mark S. Gorder, IntriCon’s president and chief executive
officer, “This is a significant milestone in hearing health and
device access, that has received broad bipartisan support. We
believe that this legislation has the potential to 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. Equally important, the Over-the-Counter Hearing Aid Act
aligns with our efforts to establish a new direct-to-consumer
distribution through Hearing Help Express.”
IntriCon acquired a 20 percent stake in DeKalb, Ill.-based
Hearing Help Express (HHE), a direct-to-consumer mail order hearing
aid provider, in the fourth quarter of 2016. In January 2017, the
company announced that it exercised its option to acquire the
remaining 80 percent stake in HHE—the purchase is expected to close
during the fourth quarter. HHE has been providing hearing care
direct to consumers (DTC) for the last 20 years, serving patients
in rural and poorer urban areas with mild, moderate and
moderate-severe hearing loss.
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, “We feel this legislation will allow us to
further 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/20170803006511/en/
At IntriCon:Scott Longval, CFO,
651-604-9526slongval@intricon.comorAt Padilla:Matt Sullivan,
612-455-1700matt.sullivan@padillaco.com
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