CLEVELAND — University Hospitals Cleveland Medical Center and UH Rainbow Babies and Children's Hospital are set to hold a clinical trial for an implantable hearing device in children 5 to 11 years old who were born with hearing loss caused by craniofacial abnormalities.
The trial is sponsored by Cochlear Americas and expects to enroll five to 10 patients at UH.
Craniofacial abnormalities can cause children to be born without a fully formed external ear or an underdeveloped ear canal, preventing sound from going through the outer and middle ear—resulting in hearing loss.
With the implant of a bone conduction hearing device, surgeons can help deliver sound directly into the inner ear. The hearing device, while approved for children 12 and older, has not yet been FDA approved for children ages 5 to 11, which the trial now focuses on.
The device, the Cochlear Osia System, features an internal piece that is implanted and an external sound processor that captures the sound. It is placed under the skin and is attached to a titanium implant that sends powerful vibrations through the bone to the inner ear.
The trial at UH began at the start of February and marked the first site in the nation to begin the study.
In total, eight sites will participate in the study with 50 total patients participating in the one-year trial.
“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," said Alejandro Rivas, MD, Director, Cochlear Implant Program at the UH Ear, Nose and Throat Institute.
The study aims to confirm the effectiveness and safety of the device for children in the 5-11 age range.
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