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Robotic-Assisted Versus Manual Electrode Array Insertion

Iowa Cochlear Implant Clinical Research Center Study on Robotic-Assisted Versus Manual Electrode Array Insertion

Who can join

Ages 18 to 80 · All sexes

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 to the surgical procedure(s) and prosthetic devices.

About the study

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.

What is being tested

• Robotic (device)

Sponsor: University of Iowa · Participants: 100 · Started: Jun 30, 2025

Contact the study team

• Rachel Scheperle, PhD · Phone: 319-384-9031
• Camille Dunn, PhD · Phone: 319-353-8776

Official record on ClinicalTrials.gov — NCT06951594

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.