Senate Follows House Action; Passes FDA User Fee Bill with OTC Hearing Aid Provision
On August 3, the US Senate passed the FDA Reauthorization Act, legislation reauthorizing the FDA's user fee programs for prescription drug, medical device, generic drug, and biosimilar biological products. The legislation also contains a provision that would direct the FDA to develop a category of over-the-counter (OTC) hearing aids for adults with perceived mild to moderate hearing loss. The US House of Representatives passed this legislation on July 12. This legislation will now go on to the President to be signed into law.
As this legislation progressed through Congress, the Academy met with lawmakers to share the Academy's statements on OTC Devices and Accessibility and Affordability for Hearing Care and to reinforce the important role of audiologists in optimizing hearing-care outcomes for patients. On the passage of this OTC hearing aid legislation, Academy President Ian Windmill, PhD said, "Throughout the legislative process, the Academy advocated for changes to the OTC hearing aid legislation to allow for consumers to self-direct their care in a safe and appropriate manner. While the legislation is not perfect, it is a substantial improvement over previous iterations of the bill. We will continue to engage with federal policy makers to ensure that the need for high-quality audiologic care in the hearing aid delivery model is understood and recognized as public policy solutions are discussed."
The final passage of the OTC hearing aid legislation comes after nearly two years of national dialogue prompted by the release of the President's Council of Advisors on Science and Technology (PCAST) report on age-related mild to moderate hearing loss. The National Academy of Sciences, Engineering, and Medicine (NASEM), formerly the Institute of Medicine (IOM), also convened public and private stakeholder meetings as they prepared and released their own recommendations in their report entitled Hearing Health Care for Adults: Priorities for Improving Access and Affordability. The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) hosted workshops and other events to solicit stakeholder feedback on this topic.
Academy President Windmill went on to say, "During many of the national discussions on age-related hearing loss, audiologists were frequently identified as leaders in advancing policies to improve access to services and devices for consumers. Audiologists can provide guidance to the consumer on determining if an OTC hearing aid device or other amplification product can offer the best results for hearing loss treatment. With the passage of the OTC legislation, we, as audiologists, must continue to lead through consumer education, outreach to other providers, and partnerships with federal agencies. Our efforts will now shift towards directly engaging with the FDA and FTC to shape new OTC hearing aid device regulations that will be developed and implemented in the coming months and years."
The Academy will keep members up-to-date on next steps regarding the development of a category of OTC devices as more information becomes available. Visit the Academy's website for the latest in Government Relations News.