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period on a draft guidance document related to the agency’s policies as they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
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 email@example.com,
or Ingrida Lusis, ASHA’s director of federal and political advocacy, at firstname.lastname@example.org.