FDA Opens Door to Changing Regulations on Hearing Aids, PSAPs

January 12, 2016

The Food and Drug Administration (FDA) announced that it will convene a public workshop in April to discuss alternative models for the regulation of hearing aids and personal sound amplification products (PSAPs). This workshop was prompted by recommendations from the President’s Council of Advisors on Science and Technology (PCAST) that was tasked to review accessibility and affordability of hearing aids. The FDA has also reopened its public comment period on a draft guidance document related to the agency’s policies as they pertain to PSAPs.

ASHA has been actively involved in the PCAST discussions and has submitted comments in opposition to many of the recommendations, which called for the creation of an FDA category of over-the-counter hearing aids and which would allow PSAP manufactures to claim that these consumer electronic devices can treat hearing loss. ASHA submitted comments to the FDA on the PSAP guidance when the draft was released, and it plans to review and resubmit comments based on the recent PCAST recommendations.


There has been an increased scrutiny by federal agencies on the affordability and accessibility of hearing aids. In addition to the PCAST, the Institute of Medicine is also conducting hearings and is expected to release its report later this year. ASHA has provided feedback to both of these groups.

As part of its written comments to PCAST [PDF], ASHA requested that the Council take a more comprehensive look at hearing health care—including the audiologist’s role in addressing a hearing disability—rather than solely focusing on amplification devices. ASHA also urged the Council to make recommendations that consider evidence-based hearing health care practices that improve affordable access to audiology services in addition to devices.


For more information, contact Sam Hewitt, ASHA’s director of political and grassroots advocacy, at shewitt@asha.org, or Ingrida Lusis, ASHA’s director of federal and political advocacy, at ilusis@asha.org.

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