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Academy Statement on Over-the-Counter Hearing Aid Act of 2016

Academy Statement on Over-the-Counter Hearing Aid Act of 2016

November 18, 2016 Government Relations News

On November 7, U.S. Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) announced their plans to introduce the Over-the-Counter Hearing Aid Act of 2016 when the Senate returns to session following the November 8th election. According to a statement released by Senators Warren and Grassley, “the bipartisan legislation would make certain types of hearing aids available over the counter (OTC) and remove unnecessary and burdensome requirements that currently create barriers for consumers who could benefit from hearing aids.”

The announcement of this soon-to-be introduced legislation builds on a series of national policy discussions surrounding accessibility and affordability of hearing aids for adults. Last October, the President’s Council of Advisors on Science and Technology (PCAST) voted to approve a report that recommends significant changes to the way in which older Americans can access hearing care in the United States.  This report includes a recommendation that the Food and Drug Administration (FDA) create another class of hearing aids and hearing tests that can be sold over the counter and online for persons with mild-to-moderate hearing loss typically seen in aging. This past April, the FDA held a public workshop on Good Manufacturing Processes for Hearing Aids and offered a period of public comment following the seminar for stakeholders to answer questions about the accessibility and affordability of hearing health care for adults. In June, the National Academy of Sciences (NAS) issued a report making 12 recommendations for improving hearing health care. The NAS has scheduled a meeting on December 7 to bring together stakeholders to discuss the implementation of these recommendations.

American Academy of Audiology President Ian Windmill, Ph.D., has been an active stakeholder in this national dialogue surrounding hearing health care and offered the following response about the proposed OTC Hearing Aid Act of 2016:

“In the past year, the hearing health-care community has come together to discuss the accessibility and affordability of hearing aids and other critical issues related to hearing health care for adults. Members of this community are scheduled to come together again in early December to discuss the implementation of the recommendations made in the NAS report. Though seemingly well-intentioned, the OTC Hearing Aid Act of 2016 appears to be premature.  A legislative approach could be more successful if lawmakers wait until the communities of interest have the opportunity to discuss important next steps for implementation of the NAS report recommendations. We view these discussions as critical in shaping and addressing the solutions that truly address patient needs.”

This legislation addresses only access to the device, yet access to hearing health care and treatment for hearing loss extends far beyond the device itself.  Audiologic care includes assessment and diagnosis of hearing loss, determination of the etiology of the loss and the impact on communicative function, and the development of a comprehensive treatment plan that may or may not include an amplification device.  Expanding access to hearing aids does not equate to consumers and patients receiving the comprehensive care and services they need to improve, protect and preserve their hearing health.  The Academy has been vocal in expressing our concerns over focusing exclusively on access to devices without consideration for the diagnostic and treatment services that are integral to treating patients with hearing loss. Those concerns include patient’s limitations in self-diagnosis and treatment, patient safety, patient satisfaction, the ability for the patient to successfully manage and use the hearing aids, market confusion over available products, transparency, and removing unnecessary barriers to treatment.

The Academy appreciates the renewed focus on hearing loss issues and hopes that Congress will continue to work with the main stakeholders and other policy groups to identify meaningful solutions to ensure that patients have access to the appropriate hearing health-care services and devices.  The Academy is also encouraged that two highly influential lawmakers, Senators Warren and Grassley, are engaging as champions for hearing health.  Senator Warren has a position on the Senate Health, Education, Labor and Pensions (HELP) Committee, which has jurisdiction over the currently stalled Early Hearing Detection and Intervention Act (EHDI), S. 2424.  We hope that this recent announcement signifies global support for the most critical issues in our community, including the reauthorization of the EHDI bill, before the end of the 114th Congress.

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