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Robotic-Assisted Versus Manual Cochlear Implant Electrode Array Insertion

This study is looking at two ways to insert a cochlear implant (CI) electrode array: manually (by hand) or with a robotic device called the iotaSOFT™ Insertion System. The iotaSOFT™ system is designed to insert the electrode array more smoothly and with less force. Researchers want to see if using the robot leads to less trauma inside the cochlea (inner ear) and better hearing outcomes for people receiving a cochlear implant. You might be able to join if you are between 18 and 80 years old, are a candidate for a cochlear implant, have normal cochlear anatomy, and speak English. The study will measure success by looking at how the electrode array is positioned inside the cochlea using CT scans, and by checking hearing function and speech understanding after surgery. The current status of this study is unclear.

Study design
This interventional study plans to enroll 100 participants. It will compare outcomes between those who receive a manual electrode array insertion and those who receive a robotic-assisted insertion.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, such as scalar translocation and angular insertion depth, are measured at a postoperative CT scan, which is approximately at activation or 2 weeks after surgery.

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NCT06951594

Robotic-Assisted Versus Manual Electrode Array Insertion

Recruiting
NAAges 18–80InterventionalBasic science
University of Iowa
~100 participants
Updated 2025-07-17 on ClinicalTrials.gov
What's tested:Robotic

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
scalar translocation
Measured over Postoperative standard of care CT (approximately at activation or 2 weeks)
+1 more outcome measured

Conditions

Cochlear Implantation
Robotics

Explore related trials

Hearing Loss

Where it's being run

1 sites across 1 states
Iowa1

Study leadership

  • Bruce Gantz, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Rachel Scheperle, PhD
[email protected]
319-384-9031
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • scalar translocationPostoperative standard of care CT (approximately at activation or 2 weeks)

    Postoperative CT scan will be used to assess scalar translocation

  • Angular Insertion depthPostoperative standard of care CT (approximately at activation or 2 weeks)

    Angle of the electrode array inside the cochlea, measured relative to the round window membrane.