A feasibility study which evaluated the safety and performance of MED-EL’s novel totally implantable cochlear implant (TICI) suggests it can provide “substantially improved hearing and quality-of-life outcomes”.
The study, which provided the first in-human results, evaluated the safety and performance of the implant in six adults with bilateral severe-to-profound sensorineural hearing loss.
“These results show that the TICI can be implanted via the conventional surgical approach,” the study authors said in Nature communications medicine on 8 January 2025.
“The data suggest that the TICI can yield hearing performance comparable to that of a conventional CI and can provide substantially improved hearing and quality-of-life outcomes for users.
“These conclusions can only be tentative at present – due to the small sample size, we were unable to conduct robust inferential statistics to assess the outcomes reported here. “
They said that as it was a first-in-human trial of an active neuroprosthetic device implanted via invasive surgery, such trials, by their nature, must be small.
The study took place in 2020 at the University Hospital Center of Liège, Belgium, and the University Hospital of Munich, Germany. Six participants (four female) were enrolled; three each at Liège and Munich.
The authors said the study’s main aim was to investigate the safety of the (Mi2000) TICI.
Adverse events
Fifteen adverse events occurred during the study. One was an anticipated serious adverse device effect (ASADE which, after appropriate treatment, resolved without sequelae. This was swelling at the site of implantation, with signs of an infection.
Nine adverse events were classed as adverse device effects (ADE). No unanticipated serious adverse device effects (USADE) occurred during the study. The distribution of adverse events was typical for those seen during conventional CI implantation, the researchers added.
For objective speech perception tests, use of the TICI with its internal microphone and signal processor achieved similar scores as use of an external processor. Results with the external processor were quite typical of those of users implanted with a regular CI.
“These findings suggest that the implanted components of the TICI achieve similar clinical performance outcomes as those with a conventional device,” they wrote.
Findings suggested participants’ perceived benefit from using the device was high.
From device usage statistics, five of the six participants used the TICI without an external processor considerably more frequently than with an external processor.
Researchers said their results compared favorably with a previous pilot study in Australia of another experimental fully implantable CI.
MED-EL sponsored the study and funded it. The lead authors performed the surgeries. They were Professor Philippe Pierre Lefèbvre , head of the ENT department of the University Hospital of Liège, Belgium, and Professor at the University of Liege, Belgium, and Professor Joachim Müller from the University Hospital of Munich, Germany, .
The other three authors were from MED-EL: Dr Ingeborg Hochmair, CEO and technical director, Mr Gerhard Mark and Dr Florian Schwarze, senior clinical research manager.
“The successful development of the totally implantable CI can be regarded as a milestone in the field,” the researchers said.
MED EL said the first person to receive the fully implantable cochlear implant in Europe on September 24, 2020 was a young man with almost complete hearing loss. Professor Lefèbvre performed the surgery.
