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

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

• 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) - 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.