In Northeast Ohio, three people have quietly become the first in the state to carry a hearing device that leaves nothing visible behind. At University Hospitals, one of eleven national sites in the Phase 3 ELEVATE trial, they received an investigational implant that moves the microphone and battery beneath the skin, answering a long-standing wish to stop being deaf whenever the outer piece comes off. Whether this quiet engineering step will reach the many adults who could benefit but never take the first step remains an open question, one that a year of careful observation will begin to answer
University Hospitals Joins Phase 3 Trial of Fully Implantable Cochlear Implant, Only Ohio Site
Fully under the skin, with nothing visible on the outside
Mark
What's actually different about this implant?
Mimi
Nothing sits outside the body. The microphone and battery are implanted along with the rest, so there's no processor behind the ear.
Mark
Why does Dr. Rivas call the current setup a safety hazard?
Mimi
Users remove the outer piece to sleep, shower, and swim. During those times they hear nothing at all.
Mark
Why hasn't this been done already?
Mimi
It's been pursued for decades. An implanted microphone picks up the body's own noises, like swallowing and muscle movement, and that's been a major obstacle.
Luke
The source says advances and algorithms created a pathway for large-scale evaluation. It doesn't say the noise problem is solved. That's what the trial is for.
Mark
How big is the trial?
Mimi
Fifty-six adults at 11 national sites, with enrollment closed. Three of them were implanted at University Hospitals.
Luke
Three patients is the local slice. And they're followed for one year, so no results are reported yet.
Mark
Investigators mention that fewer than 5 percent of eligible adults get implants. Does this device change that?
Mimi
They hope it might, since some people hesitate over wearing an external device.
Luke
That's a hope, and it's Dr. Rivas's framing, with an if attached. The article offers no data showing the external device is what holds people back. The device is also not available commercially in the U.S.
Il Polso
- Three Northeast Ohio patients now hear through a device with no external parts, the only Ohio participants in a national trial.
- Today's cochlear implant users go fully deaf each time they remove their outer processor to sleep, shower, or swim.
- Engineers have long struggled with implanted microphones catching the body's own noises, and new algorithms are now making larger testing possible.
- Fewer than 5 percent of eligible adults get implants, and investigators hope a fully hidden option will change that.
- The device remains investigational, and its safety and effectiveness await one year of follow-up data from 56 participants.
In Northeast Ohio, three people have quietly become the first in the state to carry a hearing device that leaves nothing visible behind. At University Hospitals, one of eleven national sites in the Phase 3 ELEVATE trial, they received an investigational implant that moves the microphone and battery beneath the skin, answering a long-standing wish to stop being deaf whenever the outer piece comes off. Whether this quiet engineering step will reach the many adults who could benefit but never take the first step remains an open question, one that a year of careful observation will begin to answer.
Three people in Northeast Ohio now carry a hearing device that is entirely hidden under the skin. They received the Totally Implantable Cochlear Implant, or TICI, at University Hospitals, the only Ohio site in the Phase 3 ELEVATE trial sponsored by Cochlear.
The difference is simple but significant. Today's cochlear implants have an external sound processor worn behind the ear, and users remove it to sleep, shower, or swim, leaving them completely deaf in those moments. Alejandro Rivas, MD, Director of the Cochlear Implant Program at University Hospitals and the hospital's principal investigator, called that both an inconvenience and a safety hazard. The TICI places both microphone and battery under the skin.
The concept has been pursued for decades, and one stubborn obstacle has been an implanted microphone that picks up the body's own sounds, such as muscle movement and swallowing. Better technology and more sophisticated algorithms now make larger testing possible.
The trial enrolled 56 adults with moderate to severe hearing loss across 11 sites, and each participant will be followed for a year. University Hospitals was chosen for its experience in cochlear implant research. Nicole Maronian, MD, said patients should not have to leave the region to reach cutting-edge care.
Investigators hope the device may also encourage the fewer than 5 percent of eligible adults who receive implants, since some people hesitate because of the external component. That outcome is not assured. The TICI remains investigational, and the year of follow-up will determine what ELEVATE can say about safety and effectiveness.
Three patients in Northeast Ohio now carry something no cochlear implant user in the United States can buy: a hearing device with nothing on the outside. They received the Totally Implantable Cochlear Implant, or TICI, at University Hospitals, the only site in Ohio taking part in a Phase 3 clinical trial of the technology. The trial is called ELEVATE.
The design is the point. A conventional cochlear implant has two parts, an implanted component and an external sound processor worn behind the ear. The investigational TICI is built to sit entirely under the skin, with both the microphone and the battery implanted. A user would hear without any visible device.
Alejandro Rivas, MD, explained why that matters in practical terms. He is Division Chief of Otology and Neurotology, Director of the Cochlear Implant Program at University Hospitals, and principal investigator for ELEVATE at the hospital. Most people with cochlear implants today take off the outer component to sleep, shower, and swim, he said. At those moments they are completely deaf, which he described as both an inconvenience and a safety hazard.
The idea of an implant with no external parts has been pursued for decades and has run into serious engineering problems. One of the largest is that an implanted microphone picks up sounds the body makes itself, including muscle movement, swallowing, and other internal noises. According to the source, advances in technology and more sophisticated algorithms have opened a path to testing the device at larger scale.
The study is sponsored by Cochlear, a global maker of implantable hearing products. Participants are adults with moderate to severe sensorineural hearing loss and poor speech understanding. Each will be followed for one year, with researchers evaluating hearing performance and safety. Enrollment has closed at 56 participants across 11 sites nationwide, and the three University Hospitals patients filled that site's allotted slots.
University Hospitals was chosen because of its earlier experience in cochlear implant research. Its team includes Dr. Rivas, co-investigator Cameron Wick, MD, an otologist and neurotologist, and audiologist Viral Tejani, AuD, PhD. Nicole Maronian, MD, chair of the Department of Otolaryngology – Head and Neck Surgery and director of the UH Ear Nose and Throat Institute, said patients should not have to leave the region to reach cutting-edge therapies. She said the hospital can bring this potentially groundbreaking technology to Northeast Ohio while helping shape the future of hearing restoration.
Investigators also see a possible effect beyond the trial itself. Cochlear implants have well-documented benefits for many people with significant hearing loss, yet fewer than 5 percent of eligible adults receive one. Dr. Rivas said that for some people, discomfort with wearing an external device is part of the decision. If fully implantable technology proves successful, he said, it may widen access for patients who have been reluctant.
That outcome is not assured. The TICI remains investigational, and no totally implantable cochlear implant is commercially available in the United States. The year of follow-up for these participants will determine what ELEVATE can say about safety and effectiveness.
Citazioni salienti
Most cochlear implant users remove the outer component to sleep, shower, and swim, leaving them totally deaf, which is an inconvenience and a safety hazard.— Alejandro Rivas, MD, principal investigator for ELEVATE at University Hospitals
Patients don't have to travel outside the region to access cutting-edge therapies.— Nicole Maronian, MD, Chair of Otolaryngology, University Hospitals
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