OTC Hearing Aids Bill: An Update from ASHA

August 23, 2017

On August 18, 2017, President Trump signed the Food and Drug Administration (FDA) Reauthorization Act of 2017 (H.R. 2430) into law. As part of the law, the FDA is required to develop regulations for over-the-counter (OTC) hearing aids within the next 3 years. ASHA has always maintained, and continues to maintain, that the best approach to addressing hearing loss is to seek the professional services of a licensed and certified audiologist. We recognize that members have many questions regarding these devices, and as the regulations are developed, additional information will be created and distributed to members.

Currently, ASHA is working with the Centers for Disease Control and Prevention (CDC) and several other audiology associations to develop unified messaging directed toward many levels of health care providers, which would allow them to direct their patients properly when seeking hearing health care. The emphasis continues to be on proper professional evaluation and treatment.

Although there will no doubt be challenges during the implementation process, as consumer awareness of hearing health care continues to grow, it offers an opportunity for audiologists to promote the value of their services. At no other time has hearing been so front and center. 

Regulatory Process

ASHA is committed to working with the 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 self-treatment model for hearing care can be better assessed. 

As the regulatory process unfolds, ASHA will continue to be involved, beginning with the submission of input on the following issues—as well as other issues raised by the FDA:

  • Setting output limits on the device
  • Labeling that indicates the devices are intended for consumers 18 years of age or older
  • Identifying warning signs for conditions for which consumers should seek medical advice
  • Ensuring that only those with mild to moderate hearing loss purchase the devices

ASHA Resources

ASHA is developing materials to assist members in providing follow-up services to those patients who may have initially chosen a self-treatment option. Following is a list of resources for consumers and members as well as some new resources that are underway.

For Consumers

For Members 

Coming Soon

  • OTC hearing aid liability waiver form [Being developed for audiologists who encounter new patients who have a device that was not dispensed by an audiologist]
  • “Cutting Through the OTC Myths” [Upcoming October 2017 article in The ASHA Leader]
  • “OTC Hearing Aid Legislation Becomes Law: What’s Next?” [Upcoming October 2017 article in The ASHA Leader]

Background

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 OTC use by children should be provided. We will continue to express concerns with H.R. 2430 while working with the FDA to develop regulations for implementation.

Before this legislation was introduced, ASHA provided formal statements to the President's Council of Advisors on Science and Technology (PCAST), the National Academy of Sciences, Engineering and Medicine (formerly the Institute of Medicine [IOM]), and the FDA. 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 Contacts

For information related to audiology professional practices, contact Neil DiSarno, ASHA's chief staff officer for audiology: ndisarno@asha.org. For information related to regulations, contact Ingrida Lusis, ASHA’s director of federal and political advocacy: ilusis@asha.org.

 

 

 


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