Sam Brusco, Associate Editor04.19.24
Cochlear Limited has received U.S. Food and Drug Administration (FDA) clearance to reduce the age of its Osia system from 12 years old to five years old for children with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness (SSD).
Osia is a new category of bone conducting hearing devices that use digital, piezoelectric stimulation to bypass damaged natural hearing system areas to send sound vibrations directly to the cochlea. According to the company, it’s the only active bone conduction system that patients can undergo 1.5T and 3T MRI scans while wearing it, without needing surgery.
"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., an eight-year-old Osia System recipient said. Adrian was diagnosed with hearing loss at four and began with the Baha Sound Processor with a Baha Softband before transitioning to the Osia System at six.
"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 eight-year-old Adrian said.
Cochlear Ltd. said the Osia system has been demonstrated to offer clinically significant improvements in high-frequency hearing for children in several published articles.
"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," added Lisa Aubert, president of Cochlear North America.
Osia is a new category of bone conducting hearing devices that use digital, piezoelectric stimulation to bypass damaged natural hearing system areas to send sound vibrations directly to the cochlea. According to the company, it’s the only active bone conduction system that patients can undergo 1.5T and 3T MRI scans while wearing it, without needing surgery.
"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., an eight-year-old Osia System recipient said. Adrian was diagnosed with hearing loss at four and began with the Baha Sound Processor with a Baha Softband before transitioning to the Osia System at six.
"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 eight-year-old Adrian said.
Cochlear Ltd. said the Osia system has been demonstrated to offer clinically significant improvements in high-frequency hearing for children in several published articles.
"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," added Lisa Aubert, president of Cochlear North America.