Robotic-Assisted Versus Manual Electrode Array Insertion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Iowa

About this trial

Robotics-assisted electrode insertion overcomes many surgeon-related kinetic limitations such as insertion speed, tremor, drift, and lack of accurate force control. In human cadaveric cochleae, robotics-assisted electrode insertion causes less intracochlear trauma compared to manual insertion. Whether this technical advance results in functional benefits in CI patients remains unknown. To address this critical knowledge gap, the investigators will compare cochlear trauma assessed using CT scans, cochlear and AN function assessed using ECochG and/or the eCAP, and clinical outcomes quantified by postoperative residual acoustic hearing and speech perception scores between participants randomized to either manual or robotics-assisted electrode array insertion.

Eligibility criteria

Qualifiers

Candidate for a cochlear implant according to CMS guidelines

Willingness to comply with all study requirements

Patent cochlea and normal cochlear anatomy, as confirmed by preoperative imaging

English speaking

Disqualifiers

Medical or psychological conditions that contraindicate undergoing surgery

Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.

Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.

Trial design

Treatments tested in this trial

  • Robotic

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators