IntriCon Corporation Endorses FDA’s Efforts To Improve Hearing Aid Use And Innovation

Recent FDA Comments Align with Company’s Emphasis on Lower-Cost Hearing Aid Alternatives

ARDEN HILLS, Minn.--(BUSINESS WIRE)--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.”

“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.”

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the FDA announced that it will convene stakeholders for a public workshop, and has reopened a public comment period on draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).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 Corporation
Headquartered 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 Statements
Statements 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.