Robotic-Assisted Versus Manual Electrode Array Insertion

Description

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.

Interventions

• Robotic (Device)
  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.

Eligibility criteria

Conditions

Locations

• University of Iowa Healthcare — Iowa City, Iowa, United States