Market Overview

Senate Passes the Over-the-Counter Hearing Aid Act of 2017 Bringing Affordable and Accessible Hearing Health Care Closer to Reality

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The U.S. Senate today passed the Over-the-Counter Hearing Aid Act of
2017. The bill was already passed by the House of Representatives on
July 12. With this groundbreaking legislation Congress has sent a
message to America that people with hearing loss need – and deserve –
more affordable and accessible hearing health care.

The Hearing Loss Association of America (HLAA) has supported the
Over-the-Counter Hearing Aid Act since it was introduced in the Senate
by Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) in March of this
year. The companion House bill was introduced by Representatives Joe
Kennedy III (D-MA) and Marsha Blackburn (R-TN). "Senators Warren and
Grassley and Representatives Kennedy and Blackburn – among many others –
have worked tirelessly to ensure passage of this bill. Their efforts are
sure to make a significant difference in the lives of millions of people
with hearing loss," said Barbara Kelley, HLAA executive director.

The Over-the-Counter Hearing Aid Act of 2017 would make certain types of
hearing aids available over the counter to adults with mild to moderate
hearing loss. In addition, the proposed legislation would require the
Food and Drug Administration (FDA) to regulate this new category of OTC
hearing aids to ensure they meet the same high standards for safety,
consumer labeling and manufacturing protection that all other medical
devices must meet. This will give consumers the option to purchase a
safe, high-quality FDA-regulated device at lower cost.

Since this new category has not yet been created it is unclear how the
devices will be defined. However, they should not be confused with
products already on the market called PSAPs (Personal Sound
Amplification Products). PSAPs cannot legally be marketed to people with
hearing loss as a "hearing aid," only to those with normal hearing as an
amplification device.

Now that the Over-the-Counter Hearing Aid Act of 2017 has been passed by
both the House and Senate it will go to the president to sign into law.
Once the bill is signed into law it will go to the FDA to begin drafting
the rules and regulations. While the FDA has three years to complete
that process we are hopeful that it will be done much sooner. HLAA is
currently working with the FDA on labeling of OTC products, product
safety and consumer protection.

Don't Wait to Get Your Hearing Checked

If you think you have a hearing loss, do not wait for over-the-counter
hearing aids to come to market. First, there will be an extended
rulemaking period where anyone can comment after which the FDA has to
evaluate and decide on the standards for an OTC device. Second, not
everyone will be able to get help from an OTC device. HLAA recommends
seeing an audiologist or hearing instrument specialist if you are having
trouble on the phone, asking others to repeat, turning up the volume on
your television, or showing other warning
signs
. Untreated hearing loss can cause falls, isolation,
depression, anxiety, and it has been shown that there is a link to
cognition. Hearing loss should be prevented, screened for, and treated
without delay.

The future of hearing health care is changing, allowing people to make
informed choices. HLAA will ensure consumers have unbiased and factual
information and updates about new products, regulations, and legislation
as they develop.

About the Hearing Loss Association of America

The Hearing Loss Association of America (HLAA), founded in 1979, opens
the world of communication to people with hearing loss through
information, education, support and advocacy. HLAA holds annual conventions
(HLAA2018 is in Minneapolis, Minnesota, June 21 – 24), produces Walk4Hearing
events in 20 cities, publishes the bimonthly Hearing
Loss Magazine
, advocates
for the rights of people with hearing loss, and has an extensive network
of chapters and state organizations
across the country. The national
headquarters is located at 7910 Woodmont Avenue, Suite 1200, Bethesda,
MD 20814. Phone 301.657.2248 or visit hearingloss.org.

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