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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a robotic tool can make cochlear implant surgeries safer and more effective by reducing surgical trauma. The researchers will compare surgeries using Robotic-Assisted Electrode Array Insertion to traditional manual surgeries to determine which method improves hearing and speech outcomes. Suitable candidates for this trial include individuals who need a cochlear implant, have regular cochlear anatomy, and are willing to follow study guidelines. As an unphased trial, this study offers a unique opportunity to contribute to innovative surgical advancements and potentially improve future cochlear implant procedures.

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 prior data suggests that this robotic-assisted electrode insertion is safe for cochlear implant surgery?

Research has shown that using a robot to assist in inserting electrode arrays holds promise for safety. The FDA-approved iotaSOFT™ Insertion System for cochlear implants ensures a steady insertion speed and avoids human errors, such as shaking hands. This could potentially cause less damage inside the ear compared to traditional methods.

One study found that this robotic system might protect hearing better over a year than manual insertion, suggesting it may be gentler on the inner ear. Since the device is already FDA-approved for cochlear implants, it has met strict safety standards for use in people.

Overall, current findings support the safe use of robotic-assisted insertion for cochlear implants. However, potential benefits and risks can vary for each person, so discussing participation in a trial with healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the robotic-assisted electrode array insertion for cochlear implant surgery because it offers greater precision and stability compared to traditional manual techniques. This approach uses the iotaSOFT™ Insertion System, an FDA-approved tool, to assist surgeons during the electrode insertion process, potentially reducing the risk of damage to delicate inner ear structures. By enhancing accuracy and control, this robotic assistance could lead to better hearing outcomes and quicker recovery times for patients.

What evidence suggests that robotic-assisted electrode array insertion is effective for cochlear implant surgery?

This trial will compare robotic-assisted electrode array insertion with manual cochlear implant surgery. Studies have shown that robotic assistance during electrode insertion can better preserve hearing. In one study, patients who underwent the robotic-assisted procedure retained their hearing better over a year compared to those who had manual surgery. The robot aids surgeons by maintaining a steady pace, reducing errors such as shaking or drifting. In trials, the robotic method succeeded in 95.2% of patients, demonstrating promising results. This technique aims to minimize surgical damage, potentially leading to better hearing outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Bruce Gantz, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12576857/

Robotic-Assisted Electrode Array Insertion Improves Rates ... Robotic-assisted electrode array (EA) insertion is a promising technique that may enhance hearing preservation in cochlear implant (CI) surgery.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lary.32318?af=R

Robotic‐Assisted Electrode Array Insertion Improves Rates ... Robotic-assisted EA insertion is associated with improved hearing preservation over 1 year compared with manual insertion.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06951594

Robotic-Assisted Versus Manual Electrode Array Insertion The iotaSOFT™ Insertion System is an FDA approved cochlear implant (CI) electrode array insertion tool. It provides surgeons with consistent insertion speed and ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1335994/full

Robotic assistance during cochlear implantation Robotics-assisted EA insertion is an emerging technology that may overcome fundamental human kinetic limitations that prevent consistency in achieving steady ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9757840/

A Steadier Hand: The First Human Clinical Trial of a Single ... Results: Successful robotic-assisted insertion of lateral wall cochlear implant electrode arrays was achieved in 20 of 21 (95.2%) patients. One ...

6. kjorl.org kjorl.org/journal/view.php?viewtype=pubreader&number=8820

Robot-Assisted Cochlear Implant Electrode Array Insertion The goals of robotic CI surgery are to avoid overdrilling of the mastoid, to preserve residual hearing through more consistent insertion ...