CLEVELAND — University Hospitals Cleveland Medical Center and UH Rainbow Babies and Children’s Hospital are participating in a clinical trial for an implantable hearing device in children 5 to 11 years of age who have been born with hearing loss that may be caused by craniofacial abnormalities.
UH became the first site in the nation to kick off the trial, sponsored by Cochlear Americas, at the beginning of February. The trial at UH is expected to enroll five to 10 patients this year.
Craniofacial abnormalities can cause children to be born without a fully formed external ear or with an underdeveloped ear canal. In both cases, the malformations can prevent sound from going through the outer and middle ear, causing hearing loss.
Surgeons can implant bone conduction hearing devices that conduct sound through the bone and deliver it directly to the inner ear. While the device being studied is currently FDA cleared for children 12 and older, it is not cleared for children from 5 to 11 years of age.
“Children born with this hearing loss need to be treated at a younger age than 12 years old for their cognitive development,” said Alejandro Rivas, MD, Director, Cochlear Implant Program at the UH Ear, Nose and Throat Institute. “In this study, we seek to confirm the effectiveness and safety of this device for children in the 5- to 11-year-old age group.”
There will be eight sites participating across the country and the study will enroll 50 patients in total. The enrollment phase of the trial will run for six to 12 months, and each patient will participate for one year.
The new study uses the Cochlear™ Osia® System developed by the global company Cochlear Limited. The Osia System has two parts, an internal piece that is implanted and an external sound processor that captures the sound environment. You can see how the Osia System works in the below video.
More Headlines:
