Robotics for Cochlear Implant Surgery

Overseen By Camille Dunn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Surgery contraindications, Cochlear anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

100 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Robotic-Assisted Electrode Array Insertion for cochlear implant surgery?

Research shows that robotic-assisted cochlear implant insertions can lead to less trauma inside the ear compared to manual methods, suggesting it may be a gentler and more reliable option for patients. ^{1 2 3 4 5}

Is robotic-assisted cochlear implant surgery safe for humans?

Research shows that robotic-assisted cochlear implant surgery is generally safe. In studies, the robotic system helped insert the implant electrodes accurately without causing damage, and no complications were reported during or after the surgery. ^{1 2 3 4 6}

How is robotic-assisted electrode array insertion different from other treatments for cochlear implant surgery?

Robotic-assisted electrode array insertion is unique because it uses a robot to help place the electrode into the cochlea with high precision, reducing human error and involuntary tremors. This method aims to be minimally invasive and preserve the delicate structures inside the ear, potentially leading to better hearing outcomes and fewer complications compared to traditional manual insertion methods. ^{4 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Bruce Gantz, MD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for individuals who are candidates for cochlear implants. Specific eligibility criteria aren't provided, but typically participants should be in good health and have hearing loss that may benefit from the implant.

Inclusion Criteria

Candidate for a cochlear implant according to CMS guidelines

Willingness to comply with all study requirements

English speaking

Exclusion Criteria

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

I have health or mental conditions that make surgery unsafe for me.

My inner ear has no abnormalities that would prevent surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cochlear implant surgery with either manual or robotics-assisted electrode array insertion

1 day

1 visit (in-person)

Postoperative Assessment

Postoperative CT scans and initial activation to assess cochlear trauma and electrode function

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for electrode impedance and functional status of the cochlea and auditory nerve

12 months

3 visits (in-person)

Treatment Details

Interventions

• Robotic-Assisted Electrode Array Insertion

Trial Overview The study compares robotic-assisted electrode insertion with manual insertion during cochlear implant surgery. It aims to see if robotics can reduce trauma and improve outcomes like residual hearing and speech perception.

Participant Groups

Group I: Robot Experimental Treatment 1 Intervention

The iotaSOFT™ Insertion System is an FDA approved cochlear implant (CI) electrode array insertion tool. It will be used to assist the surgeon with the cochlear implant insertion.

Group II: Manual Active Control 1 Intervention

Manual cochlear implant surgical procedure without robotic assistance.

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Comparative study of vestibular function preservation in manual versus robotic-assisted cochlear implantation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Comparative Analysis of Robotics-Assisted and Manual Insertions of Cochlear Implant Electrode Arrays. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Steadier Hand: The First Human Clinical Trial of a Single-Use Robotic-Assisted Surgical Device for Cochlear Implant Electrode Array Insertion. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Force measurement of insertion of cochlear implant electrode arrays in vitro: comparison of surgeon to automated insertion tool. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Pediatric Robotic Cochlear Implantation in Phantoms. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Preliminary application of robot-assisted electrode insertion in cochlear implantation]. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Robot-assisted Cochlear Implant Electrode Array Insertion in Adults: A Comparative Study With Manual Insertion. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Robot-Assisted Electrode Insertion in Cochlear Implantation Controlled by Intraoperative Electrocochleography-A Pilot Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Force of cochlear implant electrode insertion performed by a robotic insertion tool: comparison of traditional versus Advance Off-Stylet techniques. [2021]