i3 - September/October 2016 - 36

Policy

By Ron Schneiderman

R EG U L ATO RY T R E N DS

A

committee of the National Academies of Sciences,
Engineering and Medicine has recommended that
the Food and Drug Administration (FDA) change
its rules on hearing aids that would make it easier
for consumer technology vendors to establish a foothold in this
multi-billion dollar market.
One of the recommendations calls for
establishing a new category of over-thecounter (OTC) wearable hearing devices.
The OTC device classification would be
separate from hearing aids and would
be defined as a wearable device that
can assist adults with mild to moderate
hearing loss. The committee also recommended that the FDA retain a guidance
document on personal sound amplification products (PSAPs) that would
establish a distinction between PSAPs
for normal hearing and the OTC device
category for hearing loss.
PSAPs, by law, can't be labeled or promoted as intended to help with hearing
loss (an ad in the AARP Bulletin says
"They're not hearing aids"), but they're

popular with many people with mild
hearing issues because they are much
cheaper than hearing aids. A 2014 survey
of the PSAP market by CTA found that
the average price of one hearing aid was
$2,363, with premium models costing
$2,898. Behind-the-ear PSAP prices
ranged from $200 (even less for some
models) to $600.

Wide PSAP Support
Not surprisingly, several organizations
have filed their positions with the FDA.
CTA has urged the FDA to open the
market for PSAPs for people with mild
to moderate hearing loss. CTA says its
research found that the majority - 84
percent - of Americans with some level

of hearing difficulty say they would go
to a healthcare professional to address
hearing loss concerns.
AARP supports making PSAPs more
widely available, and has urged the
FDA to withdraw its guidance, which it
says "unnecessarily limits consumers'
ability to access PSAPs." Bose Corp.
says it believes that technical advances
have made it possible for consumers to
configure OTC hearing aids appropriately
to their hearing loss without any
expert-level knowledge about hearing
or signal processing, and without
intervention from a professional.
(Disclosure: The author of this article
wears prescribed hearing aids that
are paired with a TV and smartphone
via Bluetooth.)
In fact, some audiologists already
recommend the use of PSAPs to patients
with moderate hearing loss following an
examination. According to the Academy
of Doctors of Audiology, the FDA does
not regulate the practice of audiology,
and prescribing a PSAP is like selling any
other consumer technology product.

Now Hear This
Hearing aids are a huge market. A
Research and Markets Study projects
global hearing aid sales will climb to $8.3
billion in 2020 from $6.1 billion in 2015,
based largely on an aging population.
AARP estimates that about 48 million
Americans have measureable hearing
loss. Will OTC wearable hearing or PSAP
devices fall into the "wearables" market?
How might this issue play out? Some
regulatory specialists believe that even if
the FDA adopts the National Academies
committee's recommendations, final
rules that reconcile the three categories of
devices; hearing aids, over-the-counter
hearing aids and PSAPs, will be a year or
more in the making.
n
For more information, see the President's
Council of Advisors on Science and
Technology (PCAST) report.

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SEPTEMBER/OCTOBER 2016

I T I S I N N O VAT I O N

PHOTOGRAPH BY BSIP SA/ALAMY

Will Hearing Aids Become
the New Big Wearable?
https://www.whitehouse.gov/administration/eop/ostp/pcast/docsreports https://www.whitehouse.gov/administration/eop/ostp/pcast/docsreports https://www.whitehouse.gov/administration/eop/ostp/pcast/docsreports
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