Cochlear Receives FDA Approval to Expand Osia System Usage to Children Aged 5 and Up

20 April 2024

Cochlear Limited is a leading provider of implantable hearing solutions, has received approval from the U.S. Food and Drug Administration (FDA) to lower the age requirement for the Cochlear™ Osia System from 12 years to 5 years. This expansion allows children with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness (SSD) to benefit from the technology.

System is an innovative bone conduction hearing solution that utilizes digital piezoelectric stimulation to deliver sound vibrations directly to the inner ear (cochlea), bypassing damaged areas of the natural hearing system. Notably, it is the first and only active bone conduction system that enables patients to undergo MRI scans at both 1.5 T and 3.0 T without the need for additional surgery.

With the lowered age limit, children as young as 5 will now have access to the Osia System's advanced technology, which is optimized to provide high power and clarity, particularly in high-frequency sounds crucial for effective communication

Expressed gratitude for the transformation in her child's life: "It has been amazing to see the difference in Adrian.  

Clinical studies have demonstrated significant improvements in high-frequency hearing in children using the Osia System, earning praise from professionals noted the remarkable clarity provided by the Osia System, with patients reporting hearing previously unnoticed sounds such as birds chirping.

The company's dedication to transformative technology: "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."

 

Source: prnewswire.com