On August 3, by a vote of 94-1, the Senate passed H.R. 2430, the Food and Drug Administration (FDA) Reauthorization Act of 2017. Included in this legislation was the Over-the-Counter (OTC) Hearing Aid Act of 2017, which requires the FDA to develop regulations for a new class of OTC hearing aids for adults with perceived mild to moderate hearing loss. It is anticipated that the President will sign this bill into law.
The legislation mandates the FDA to develop rules (within the next three years) on how OTC hearing aids will be regulated. As part of the rulemaking process, the FDA must ensure that OTC devices are safe and effective. Some of the factors that need to be considered include setting output limits for the devices, labeling to indicate that the devices are intended for people over the age of 18, and identifying how these devices will be accessible absent professional involvement.
The legislation also requires the U.S. Department of Health and Human Services (HHS) to report back to Congress on any adverse effects two years after the regulations are in place.
ASHA advocated to Congress that OTC hearing aids should only be available for perceived mild hearing loss, that output limits must be set, and that warnings against use in children should be provided. ASHA maintains that the best approach to addressing hearing loss is to seek the professional services of an audiologist and will continue to express its concerns with H.R. 2430 as it works with the FDA to develop regulations for implementation.
In 2015, ASHA provided formal statements to the President's Council on Advisors on Science and Technology (PCAST), the National Academy of Sciences, Engineering and Medicine (formerly the Institute of Medicine or IOM), and the FDA before this legislation was introduced. ASHA provided testimony on the need for audiologists to be actively involved in the selection of appropriate amplification. ASHA's position focused on hearing loss as a chronic medical condition and the need for patient access to comprehensive audiology services including identification, assessment, and rehabilitation of hearing loss.
ASHA Audiology Professional Practices Efforts
ASHA is committed to working with FDA on the development of OTC hearing aid regulations with a focus on consumer safety. The FDA is charged with ensuring that OTC devices are safe and effective before they go to market. ASHA will strongly urge the FDA to track the safety and user satisfaction issues that arise with greater access to OTC hearing aids. By doing so, the implications of a do-it-yourself model for hearing care can be better assessed.
ASHA provides the following resources for consumers and audiologists:
For information related to audiology professional practices, contact Neil DiSarno, ASHA's chief staff officer for audiology, firstname.lastname@example.org.
For information related to legislation, contact Ingrida Lusis, ASHA’s director of federal and political advocacy,