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

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)

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 Cochlearâ„¢ 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.

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