University Hospitals Among First in Nation to Advance Next Generation Fully Implantable Technology Through Clinical Trial

CLEVELAND – University Hospitals is bringing the next generation of hearing technology to patients in Northeast Ohio as the only site in the state participating in a Phase 3 clinical trial evaluating the Totally Implantable Cochlear Implant (TICI). The ELEVATE trial is studying this investigational device which is designed to provide hearing without any external components.

Unlike conventional cochlear implants which include both an implanted component and an external sound processor worn behind the ear, the investigational TICI system is designed for placement completely under the skin. The microphone and battery are implanted, allowing users to hear without any visible external device.

“We’re excited to see any potential benefits,” said Alejandro Rivas, MD, Division Chief of Otology and Neurotology, and Director of the Cochlear Implant Program at University Hospitals, as well as the Principal Investigator for the ELEVATE trial at UH. “Today, most patients with cochlear implants remove the outer component when they sleep, shower, and if they go swimming. This means they’re totally deaf at those times, which is an inconvenience and also a safety hazard.”

The concept of a TICI has been pursued for decades but has faced significant engineering challenges. One of the biggest obstacles is managing sounds generated by the body itself, including muscle movement, swallowing, and other internal noises that an implanted microphone can detect. Advances in technology and sophisticated algorithms have created a pathway for large-scale clinical evaluation.

Three patients recently received the TICI device at University Hospitals, filling the institution’s allocated enrollment slots in the trial. Participants are adults with moderate to severe sensorineural hearing loss and poor speech understanding. They will be followed for one year to evaluate hearing performance and safety. The study is sponsored by Cochlear, a global leader in implantable hearing solutions. Trial enrollment is now concluded for 56 participants at 11 national sites.

University Hospitals was selected to participate in the trial based on its past experience in cochlear implant research. The experienced site team at UH includes co-investigator Cameron Wick, MD, otologist/neurotologist, and audiologist Viral Tejani, AuD, PhD. 

“Participation in studies like this demonstrates UH’s commitment to innovation,” said Nicole Maronian, MD, Chair of the Department of Otolaryngology – Head and Neck Surgery, and the Director of the UH Ear Nose and Throat Institute. “Our patients don’t have to travel outside the region to access cutting-edge therapies. We’re able to bring this potentially groundbreaking technology directly to Northeast Ohio while helping shape the future of hearing restoration.”

Investigators also hope the technology may eventually encourage more people to consider cochlear implantation. Despite evidence showing the benefits of cochlear implants for many individuals with significant hearing loss, less than 5 percent of eligible adults currently receive one.

“A large number of people who could benefit from cochlear implants choose not to pursue them,” said Dr. Rivas, who is also the Richard W. and Patricia R. Pogue Chair in Auditory Surgery and Hearing Sciences. “For some, concerns about wearing an external device are part of the decision. If fully implantable technology proves successful, it may help expand access to hearing restoration for patients who have been reluctant to consider cochlear implantation.”

No totally implantable cochlear implant is currently commercially available in the United States. The ELEVATE trial is an important step in evaluating the safety and effectiveness of this investigational system.

As the only Ohio institution participating in the study, University Hospitals continues its mission of delivering leading-edge care, giving patients access to innovative technologies that have the potential to redefine treatment options and improve quality of life.

###

Consultancy Disclosure: Alejandro Rivas, Cameron Wick, and Viral Tejani have provided independent consulting services to Cochlear within the past 12 months.