- In the United States, the
Osia System is now cleared for children ages 5 and older
- The Osia System, which launched commercially in 2020, is
indicated for people with conductive hearing loss, mixed hearing
loss and single-sided sensorineural deafness (SSD)
- The Osia System has been shown to provide clinically
significant improvements in high frequency hearing for
children.2,3,4
LONE TREE, Colo., April 19, 2024 /PRNewswire/ -- - Cochlear Limited
(ASX: COH), the global leader in implantable hearing solutions,
obtained U.S. Food and Drug Administration (FDA) clearance to lower
the age of the Cochlear™ Osia System from 12 years-old to
5-years-old for children with conductive hearing loss, mixed
hearing loss and single-sided sensorineural deafness (SSD).
"The Osia System has truly been life
changing," Dea R., parent to 8-year-old Adrian said.
The Osia System is a new category of bone conduction
hearing solutions that uses digital piezoelectric stimulation to
bypass damaged areas of the natural hearing system to send sound
vibrations directly to the inner ear (cochlea). It is the first and
only active bone conduction system that allows patients to undergo
MRI scans at both 1.5 T and 3.0 T without the need for
surgery.1
Now children as young as 5 will be able to have full access to
the Osia System's unique technology that is optimized to deliver
high power and clarity, especially in high-frequency sounds, which
are important for hearing what others are saying.
"I love my Osia System. It's given me the confidence to succeed
in school. I can hear everything my teacher and my friends say,"
Adrian R., 8-year-old Osia System recipient said.
Adrian was diagnosed with hearing loss at age 4 and started with
the Baha® Sound Processor with a Baha Softband before transitioning
to the Osia System at age 6.
"It has been amazing to see the transformation in Adrian. She
has been doing so well in school and is able to keep up with her
friends both in school and out. She is even learning the piano now
and I never thought I would be able to say that. It has truly been
life changing," Dea R., parent to 8-year-old Adrian said.
The Osia System has been shown to provide clinically significant
improvements in high frequency hearing for
children.2,3,4
"I choose the Osia System for my pediatric patients because it
really made the difference in terms of the sound clarity. It is
absolutely incredible," Dr. Daniela
Carvalho, Pediatric Otolaryngologist at Rady Children's
Hospital said.
"All of my patients with the Osia System have come back to my
office saying it's the first time they've heard the birds chirping
or other high-frequency sounds."
Cochlear's product portfolio is inspired by meaningful
innovation and a core belief that technology is only as useful as
the benefit it provides.
"The Osia System is transformative technology, and we're pleased
that it's now accessible for children as young as 5. This aligns
with our commitment to empower people across all stages of life to
stay connected and thrive," Lisa
Aubert, President, Cochlear North America said.
About Cochlear Limited (ASX: COH)
People have always
been Cochlear's inspiration, ever since Professor Graeme Clark set out to create the first
multi-channel cochlear implant after seeing his father struggle
with hearing loss. Since 1981, Cochlear has provided more
than 750,000 devices in more than 180 countries, helping people of
all ages around the world to hear. As the global leader in
implantable hearing solutions, Cochlear connects people with life's
opportunities, and welcomes them to the world's largest hearing
implant community.
Cochlear has a global workforce of around 4,800 people, with a
passion for progress, who strive to meet the needs of people living
with hearing loss. The company continually innovates to anticipate
future needs, investing more than AUD$2.7 billion to date in
research and development to push the boundaries of technology and
help more people hear.
References
- Ellsperman SE, Nairn EM, Stucken EZ. Review of Bone Conduction
Hearing Devices. Audiol Res. 2021;11(2):207-219.
- ClinicalTrials.Gov ID NCT 0500931
- You, P., A. Choi, J. Drob, S. M. Hunsaker, Y. C. Liu, and R.
Silva. 2022. 'Early Outcomes of a New Active Transcutaneous Bone
Conduction Implant in Pediatric Patients', Otol Neurotol, 43:
212-18.
- Florentine, M. M., J. Virbalas, and D. K. Chan. 2022. 'Early
surgical and audiologic outcomes of active, transcutaneous,
osseointegrated bone-conduction hearing device (Osia 2® system)
placement', International Journal of Pediatric Otorhinolaryngology,
156.
Cochlear, 科利耳, コクレア, 코클리어, Hear now. And always, Osia,
SmartSound, the elliptical logo, and marks bearing an ® or ™
symbol, are either trademarks or registered trademarks of the
Cochlear group of companies (unless otherwise noted).
In the United States and
Canada, the Osia System is
indicated for ages 5 and older.
© Cochlear Limited 2024. All rights reserved.
"This material is intended for health professionals. If you are
a consumer, please seek advice from your health professional about
treatments for hearing loss. Outcomes may vary, and your health
professional will advise you about the factors which could affect
your outcome. Always read the instructions for use. Not all
products are available in all countries. Please contact your local
Cochlear representative for product information."
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SOURCE Cochlear North America