Iowa Cochlear Implant Clinical Research Center Study on Robotic-Assisted Versus Manual Electrode Array Insertion
University of Iowa
Summary
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.
Description
Electrode insertion force is a critical determinant of the degree/amount of intracochlear trauma caused by CI surgery. It is affected by the speed of electrode array insertion, with higher insertion speeds leading to greater insertion forces. In addition, rapid electrode array insertions with higher forces are associated with translocation of electrode arrays from the scala tympani into the scala media or vestibuli which leads to lower performance and higher rates of loss of residual hearing. Furthermore, variability in insertion force during electrode insertion can cause dramatic increases in…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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…
Interventions
- DeviceRobotic
The iotaSOFT™ Insertion System is an FDA approved cochlear implant (CI) electrode array insertion tool. It provides surgeons with consistent insertion speed and force. The system consists of a drive unit connected to a touch screen control console and foot pedal interface. The surgeon secures the base to the skull with two pre-loaded self-drilling bone screws. The drive unit is placed into the base and the adjustable drive head is coupled to a CI electrode. Before insertion begins, the surgeon selects the desired speed of insertion. the surgeon controls the electrode insertion forward and reverse motion via foot pedal while guiding the electrode array into the cochlea with standard CI instrumentation. Upon the completion of electrode array insertion, the drive head and unit are uncoupled from the electrode lead and removed from the patient for disposal.
Location
- University of Iowa HealthcareIowa City, Iowa