Cochlear, an implantable hearing solutions developer, has received clearance from the US Food and Drug Administration (FDA) to expand the use of its Osia System to children as young as five years old.
This decision lowers the eligible age from 12 years to five, allowing younger children with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness (SSD) to benefit from the technology.
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By GlobalDataThe Osia System represents a new category of bone conduction hearing solutions. It employs digital piezoelectric stimulation to bypass damaged areas of the natural hearing system and directly send sound vibrations to the inner ear.
It is claimed to be the first and only active bone conduction system that permits patients to undergo MRI scans at both 1.5 tesla (T) and 3.0T without requiring surgical intervention.
Cochlear stated that with this FDA clearance, children as young as five years old will now have full access to the Osia System’s advanced technology.
The system is designed to deliver high power and clarity, particularly in high-frequency sounds, which are crucial for understanding speech.
Cochlear North America president Lisa Aubert said “The Osia System is a transformative technology, and we’re pleased that it’s now accessible for children as young as five. This aligns with our commitment to empower people across all stages of life to stay connected and thrive.”
Launched last August, the Cochlear Osia System is the company’s next-generation active bone conduction system.
The Osia OSI300 implant, a component of the system, was engineered to improve hearing outcomes for individuals with mixed and conductive hearing loss, as well as those with single-sided sensorineural deafness.
Unlike axial magnets found in many bone conduction implants, which are incompatible with 3T MRI scans, the OSI300 implant utilises a diametric magnet. This magnet is encased and can rotate to align with the magnetic field of an MRI machine, making it MRI-friendly at higher Tesla levels.
