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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
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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