Robotic-Assisted Versus Manual Electrode Array Insertion

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

August 31, 2028

Conditions
Cochlear ImplantationRobotics
Interventions
DEVICE

Robotic

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.

Trial Locations (1)

52242

RECRUITING

University of Iowa Healthcare, Iowa City

All Listed Sponsors
lead

University of Iowa

OTHER

NCT06951594 - Robotic-Assisted Versus Manual Electrode Array Insertion | Biotech Hunter | Biotech Hunter