Cochlear receives FDA clearance to lower the age for the Osia System to 5-years-old

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Apr 19, 2024, 11:43 ET

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 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.

"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."

SOURCE Cochlear North America