CLEVELAND — University Hospitals (UH) is the first site in the United States to study 5 to 11-year-olds with congenital abnormalities using implantable hearing devices.
University Hospitals Cleveland Medical Center and UH Rainbow Babies & Children's Hospital are participating in a Cochlear Americas'-sponsored clinical trial for children born with hearing loss that may be caused by craniofacial abnormalities using the Osia System.
According to a press release from UH, the abnormalities can cause children to be born without a full formed external ear or with an underdeveloped ear canal, and in both cases the malformations can prevent sound from going through the outer and middle ear, causing hearing loss.
The device that is being studied is currently FDA cleared for children 12 and older, but it is not cleared for children 5 to 11-year-olds.
“Children born with this hearing loss need to be treated at a younger age than 12 years old for their cognitive development,” Dr. Alejandro Rivas, director of the Cochlear Implant Program at the UH Ear, Nose & Throat Institute, said in the press release. “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.”
According to the press release, 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.
“UH and UH Rainbow have been pioneers on multidisciplinary care for children born with craniofacial anomalies. We run the most comprehensive multidisciplinary craniofacial clinic in Ohio, and as such our pediatric patients with hearing loss will greatly benefit from this technology,” Rivas said.
More information about the clinical study can be found here. Additional information about the Osia System can be found here.