The busy MUSC Health Cochlear Implant Program is about to launch another clinical trial. This one will test a device that has a component that may address a common concern with cochlear implant surgery: the risk of additional hearing loss.
Robert Labadie, M.D., Ph.D., chair of the department of Otolaryngology, will lead the Medical University of South Carolina's part of the national trial. He described the problem the new device seeks to solve.
"When we're placing a cochlear implant, we drill a hole into the cochlea (the hearing organ in the ear) or we open the natural opening called the round window (an opening from the middle ear to the inner ear). And when you do that, there's likely a little bit of hearing loss. And over time it gets worse. If you could preserve that, people hypothesize that you would have better outcomes. But no one really knows."
That could change with the new clinical trial testing the experimental cochlear implant currently known as CI632D. It's likely to get a much more user-friendly name in the future.
"Cochlear implants consist of a piece that's implanted under your skin that's a little computer called the internal receiver. And it has an electrode that goes into your cochlea. What they're proposing is to coat the electrode with a dissolvable form of a steroid so the steroid dissolves and prevents inflammation and other scarring during the first three months of implantation. What they're hoping to show is that adding the steroid results in better hearing preservation," Labadie said.
The steroid is called dexamethasone. The company that makes the cochlear implant has an easy-to-remember name: Cochlear. It says the steroid may ease inflammation and reduce tissue injury that can come with any type of surgery.
"The current standard of care is that we take some steroid on the surgical field, and we basically squirt it into the area right before we make the hole into the cochlea. And then we put some into the cochlea and some of that sticks around for maybe hours or days. This has the potential to stick around for about three months," Labadie said.
But it's not a huge advance over existing technology, Labadie said – just a potentially beneficial one. "This is just incrementally different than a traditional cochlear implant."
To qualify for the trial, people need to have sensorineural hearing loss. It's caused by damage to the inner ear or auditory nerve. They also must have moderately severe to profound hearing loss that developed after they were able to speak and hear, and meet other criteria listed on the study's clinical trial page.
Labadie's team hopes to enroll dozens of patients in the trial at MUSC. He said that could include people who don't qualify for cochlear implants through Medicare but might through the study.
News of this study comes about a month after MUSC Health announced its participation in another cochlear implant trial. That trial is testing the effectiveness of a totally implanted (under-the-skin) device.
Labadie said the innovative new options are not surprising for a program that does more than 200 cochlear implants per year, has five telemedicine sites for post-operative care and is the only center in United States routinely doing intraoperative CT scanning after implantation for quality assurance that the electrode is in correct location and not folded over. "Our outcomes are spectacular," he said.
