ARDEN HILLS, Minn.--(BUSINESS WIRE)--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 Corporation
Headquartered 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.
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, 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.