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The FDA Reauthorization Act (H.R. 2430), recently signed into law by President Donald Trump, included the Over-the-Counter (OTC) Hearing Aid Act, which requires the Food and Drug Administration (FDA) to develop regulations within three years for hearing aids to be sold over-the-counter to individuals with mild to moderate hearing loss.
United StatesFood, Drugs, Healthcare, Life Sciences
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The FDA Reauthorization Act (H.R. 2430), recently signed into
law by President Donald Trump, included the Over-the-Counter (OTC)
Hearing Aid Act, which requires the Food and Drug Administration
(FDA) to develop regulations within three years for hearing aids to
be sold over-the-counter to individuals with mild to moderate
hearing loss.
The Senate passed the legislation 94-1, over the objections of
several industry associations, including the Hearing Industries
Association, which argued that the legislation did not provide for
"the devices [to] be safeguarded, the patient [to] be
protected, and the hearing care professional [to] remain
involved."
The deregulation of the hearing aid market is likely to lead to
a degradation of provider services, decreased product margins and
an influx of new competitors in the hearing aid market.
More important, however, the new law may signal a willingness on
the part of Congress to allow greater consumer self-determination
in the selection and purchase of healthcare products and services,
which could have a significant impact on bypassed providers. This
trend bears watching by providers.
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