IntriCon Endorses FDA's Efforts to Improve Hearing Aid Use and Innovation
January 11 2016 - 8:00AM
Business Wire
Recent FDA Comments Align with Company’s
Emphasis on Lower-Cost Hearing Aid Alternatives
IntriCon Corporation (NASDAQ: IIN), a designer,
developer, manufacturer and distributor of miniature and
micro-miniature body-worn devices, today said that it strongly
supports the U.S. Food and Drug Administration’s (FDA) new efforts
to: “better understand how the agency can appropriately balance
patient safety while encouraging advancements in hearing aid
technology and access to these devices in the United States.”
On Jan. 6, 2016, the FDA announced that it will convene
stakeholders for a public workshop, and has reopened a public
comment period on draft guidance related to the agency's premarket
requirements for hearing aids and personal sound amplification
products (PSAPs).
Said Mark Gorder, president and chief executive officer of
IntriCon, “Untreated hearing loss in the United States is a
substantial national problem. High device costs and inadequate
innovation in distribution channels are creating significant
barriers to access for most Americans.
“As the FDA highlighted in its announcement, statistics from the
National Institute on Deafness and Other Communication Disorders
indicate that 37.5 million U.S. adults aged 18 and older report
some form of hearing loss. However, only 30 percent of adults over
70 and 16 percent of those aged 20 to 69 who could benefit from
wearing hearing aids have ever used them. We applaud and back the
FDA’s efforts to overcome barriers to device access and spur the
development and innovation of cost-effective technology.”
Gorder noted that in October 2015, the President’s Council of
Advisors on Science & Technology (PCAST), the group which
advises the President and makes policy recommendations, addressed
the low hearing health market penetration levels IntriCon has long
pointed out.
PCAST also indicated that untreated hearing loss in the United
States is a substantial national problem, and supported this
assessment with references to the barriers to access. The group
recommended revising FDA regulations and changing the current
distribution channel, as well as creating new channels to increase
the opportunities for consumer choice.
Said Gorder, “The assessments offered by PCAST and the FDA are
in line with our views—and initiatives—over the last five years.
They highlight the need for an outcomes-based hearing healthcare
model in which the best value-added devices and software technology
are combined with varying levels of practitioner intervention, to
provide the most efficient, lowest cost solution, to the consumers
across the country.
“We believe this model, which we’ve been successfully working to
build, will significantly improve penetration and transform the
market. We look forward to partnering with the FDA and other
organizations to bring hearing healthcare to millions of people who
today cannot afford care through the conventional channel.”
About IntriCon CorporationHeadquartered in Arden Hills,
Minn., IntriCon Corporation designs, develops, manufactures and
distributes miniature and micro-miniature body-worn devices. The
company is focused on three key markets: medical, hearing health,
and professional audio communications. IntriCon has facilities in
the United States, Asia 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, 2014. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160111005188/en/
At IntriCon:Scott Longval, CFO,
651-604-9526slongval@intricon.comorAt PadillaCRT:Matt Sullivan,
612-455-1700matt.sullivan@padillacrt.com
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