University Hospitals enrolls 3 patients in Phase 3 trial of fully implantable cochlear implant

University Hospitals (UH) in Cleveland is the only site in Ohio taking part in a Phase 3 clinical trial of the Totally Implantable Cochlear Implant (TICI), according to news.uhhospitals.org uhhospitals.orgnews.uhhospitals.orgnews.uhhospitals.orgOpen source ↗. The ELEVATE trial studies an investigational device designed to provide hearing without any external components. Three patients recently received the device at UH, filling the hospital's allocated enrollment slots.

How the device differs

Conventional cochlear implants have an implanted component and an external sound processor worn behind the ear. The investigational TICI system is designed for placement completely under the skin, with the microphone and battery implanted.

Alejandro Rivas, MD, Director of the Cochlear Implant Program at UH and Principal Investigator of ELEVATE at the hospital, noted that most patients with cochlear implants remove the outer component when they sleep, shower or swim. They are totally deaf at those times, which he described as an inconvenience and a safety hazard.

The concept has been pursued for decades and has faced significant engineering challenges. One of the largest is handling sounds produced by the body itself, such as muscle movement and swallowing, which an implanted microphone can pick up. According to the release, advances in technology and algorithms have opened a path to large-scale clinical evaluation uhhospitals.orgnews.uhhospitals.orgnews.uhhospitals.orgOpen source ↗.

Trial design and participants

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. Enrollment is now concluded, with 56 participants at 11 sites in the United States.

UH was selected based on its past experience in cochlear implant research. The site team includes co-investigator Cameron Wick, MD, and audiologist Viral Tejani, AuD, PhD. Rivas, Wick and Tejani have provided independent consulting services to Cochlear within the past 12 months.

Investigators also hope the technology may eventually encourage more people to consider cochlear implantation. Fewer than 5 percent of eligible adults currently receive one. Rivas said concerns about wearing an external device are part of some patients' decision uhhospitals.orgnews.uhhospitals.orgnews.uhhospitals.orgOpen source ↗.

No totally implantable cochlear implant is currently commercially available in the United States. The ELEVATE trial is meant to evaluate the safety and effectiveness of this investigational system.