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HomeHealthCochlear receives FDA clearance to lower the age for the Osia System...

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 /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).