Randomized clinical effectiveness trial finds self-fitting
Lexie Lumen hearing aids continue to provide the same benefit as
audiologist-fitted hearing aids after long-term use
BOSTON, July 11,
2024 /PRNewswire/ -- A newly updated study conducted
by researchers at the University of
Colorado and the University of Pretoria (South
Africa) finds self-fitting over-the-counter (OTC) hearing
aids provide equal long-term benefit at a quarter of the cost of
audiologist-fitted devices. The study was published today in the
Journal of the American Medical Association (JAMA) -
Otolaryngology–Head & Neck Surgery, confirming that for people
with mild to moderate hearing loss, OTC continues to offer a more
affordable and equally effective solution for hearing loss.
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Researchers built upon an earlier study, also published in JAMA
in April 2023, which found that
self-fitted Lexie Lumen OTC hearing aids provided the same benefit
for people with mild to moderate hearing loss after six weeks of
use as those fitted by an audiologist. The updated research finds
that users of OTC and audiologist-fitted hearing aids experienced
equally similar benefits after eight months, further reinforcing
the quality and value of OTC hearing products.
Over-the-counter hearing aids have widely expanded Americans'
access to hearing care, as they typically cost less than a quarter
of the price of traditional, audiologist-fitted hearing aids, and
can be purchased and fitted at home, saving wearers multiple trips
to the audiologist for appointments that are often funded out of
pocket.
Half of the participants in this trial were given Lexie Lumen
hearing aids, which are commercially available online, at major
retailers and every Walgreens across the U.S., and instructed to
self-fit them as they would have if they purchased them from a
retailer. The other half were given the same hearing aids fitted by
an audiologist using the best-practice protocol when visiting an
audiologist.
"The results of this study hold great promise for the tens of
millions of Americans living with untreated mild to moderate
hearing loss," said De Wet Swanepoel, PhD, one of the study's
authors. "Hearing loss is chronically undertreated, in part because
of the expense and inconvenience of prescription hearing aids. With
clinical proof that OTC products produce the same long-term
benefit, we believe more people can and will confidently take steps
to address hearing loss so they can live longer, healthier
lives."
After the initial fitting, neither group was given access to
additional audiological or remote support for fitting or
fine-tuning. Following the initial two weeks, OTC wearers were
provided ongoing access to Lexie remote support for fine tuning.
Those with the audiologist-fitted hearing aids were able to access
support and fine-tuning from an audiologist.
Within the first two weeks of the study, Lexie wearers wore
their hearing aids longer and reported better outcomes than those
using audiologist-fitted devices. After eight months, the benefits
between self-fitted OTC hearing aids and audiologist-fitted hearing
aids were comparable with no statistically significant
difference.
"We are pleased to see that OTC hearing aids – particularly the
Lexie Lumen – continue to perform well in randomized controlled
trials against audiologist-fitted prescription products," said
Brian Maguire, Senior Vice President
for Lexie Hearing. "Broad access to
affordable, quality hearing aids is essential to our mission to
help everyone everywhere hear better."
FDA approved a new category of self-fitting hearing aids to be
sold over-the-counter by retailers across the U.S. in 2022. The
move has helped reinforce the importance of hearing health
management and introduced more hearing care options to the tens of
millions of American adults living with mild to moderate hearing
loss.
Recent data show that about 44 million adults in the U.S. have
hearing loss, but only a fraction seek the care they need. Experts
say cost, access to audiologists and embarrassment are the biggest
barriers to care. But hearing health has implications for physical,
cognitive and mental health and should not be overlooked. Untreated
hearing loss makes it hard to connect with family and friends,
severely impacts quality of life and is correlated with higher
instances of depression and dementia in older adults.
For more information about the study or Lexie Hearing, or to take a free online hearing
test, visit LexieHearing.com.
About Lexie Hearing
Lexie Hearing
(www.lexiehearing.com), a division of hearX Group, is driven by its
mission to make hearing health more affordable and accessible. As a
leader in the U.S. OTC hearing aid market, Lexie was named among
the 100 Most Influential Companies by TIME in 2023 for its
innovative technology and meaningful impact on hearing health in
America. Lexie products are clinically proven to provide similar
benefits as audiologist-fitted devices for those with mild to
moderate hearing loss for up to a quarter of the cost of
prescription devices and are sold in more than 14,000 leading
retail stores nationwide and on lexiehearing.com. Delivering
user-friendly technology, an easy-to-use app and award-winning
customer service, Lexie helps wearers get back to better hearing
quickly and easily so they can confidently live the life they
love.
About hearX Group
hearX Group (www.hearxgroup.com) is
an industry leading medtech company with a mission to make healthy
hearing accessible to everyone, everywhere. Using smart technology
and data, hearX has built a suite of smart digital solutions to
detect, diagnose and treat hearing loss around the globe, making
cost-effective hearing accessible to those who need it most. In a
few short years, hearX's footprint has grown to reach 191 countries
and more than 2.4 million people, globally.
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