President's Council Recommends OTC Hearing Aids

October 26, 2015

The President's Council of Advisors on Science and Technology (PCAST) recently voted to approve its report related to hearing technologies. The complete report, titled, Aging America & Hearing Loss Imperative of Improved Hearing Technologies, is set to be published in the coming weeks. Although recommendations from the Council are nonbinding, regulatory agencies may consider and act on these recommendations.

Background

The report makes four specific recommendations.

  1. The creation of a new and distinct category of over-the-counter (OTC) hearing aids by the Food and Drug Administration (FDA). OTC hearing aids would be available in stores or online and could be self-fitted by individuals with age-related hearing loss. OTC hearing aids would be exempt from FDA quality system regulations but must comply with consumer electronics industry standards recognized by the FDA. 
  2. The FDA should withdraw its draft guidance document on personal sound amplification products and refer to this new category as "devices for discretionary consumer use."
  3. Much like optometrists, audiologists and dispensers would be required to provide a copy of the audiogram to the consumer at no additional cost. 
  4. The Federal Trade Commission should develop a process that will enable individuals to receive copies of their audiograms.

The PCAST recommendations will potentially impact the delivery of hearing health care services. ASHA will review the report in its entirety and will develop a comprehensive strategy to address the report's recommendations. ASHA looks forward to collaborating with other stakeholders in ensuring that appropriate consumer protections remain in place while continuing to find ways to increase access and affordability of hearing technologies.

ASHA Resource

For additional information, contact Ingrida Lusis, ASHA's director of federal and political advocacy, at ilusis@asha.org.


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