Robotic vs Manual Cochlear Implantation for Hearing Loss

Overseen By Petronio Senior Clinical Research Operations Manager, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth

Disqualifiers: Pediatric, Severe comorbidities, Cochlear anomalies, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of cochlear implant insertion: manual insertion and robotic insertion using the IotaSoft Robotic Insertion System. The researchers aim to determine which method improves hearing a year after surgery. They will also assess factors such as surgery time and the condition of the inner ear and hearing nerve. Eligible candidates are adults who require a cochlear implant and have difficulty hearing low sounds. Participants will be randomly assigned to one of the two methods, both of which are safe and approved. As an unphased trial, this study allows participants to contribute to innovative research that could enhance 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 these cochlear implant insertion methods are safe?

Research has shown that the IotaSoft Robotic Insertion System for cochlear implants is well-tolerated by patients. The FDA has approved this system, indicating it has passed safety tests for use in people. Studies have found that this robotic method allows for very precise placement of the cochlear implant, which can help protect hearing during surgery.

The traditional method of inserting cochlear implants by hand is also safe and has been used successfully for many years. Skilled surgeons perform both the robotic and manual methods in a controlled environment, ensuring both are safe options for cochlear implant surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic-assisted cochlear implant insertion because it offers a novel approach to implant surgery. Unlike the standard manual technique, which relies solely on the surgeon's skill, the IotaSoft Robotic Insertion System provides enhanced precision and control during the procedure. This robotic assistance could potentially reduce surgical errors and improve outcomes for patients with hearing loss by ensuring more accurate placement of the implant. This innovation could lead to fewer complications and better hearing results, making it a promising advancement in cochlear implant surgery.

What evidence suggests that this trial's methods could be effective for hearing loss?

This trial will compare two methods for cochlear implant insertion: the IotaSoft Robotic Insertion System and Manual Cochlear Implant Insertion. Research has shown that the IotaSoft system for robotic-assisted cochlear implant surgery may lead to better hearing outcomes. The system allows for more precise implant placement, reducing force and variability during the procedure. This careful approach helps protect the inner ear, crucial for maintaining hearing. Over 1,000 surgeries have used this system, and feedback indicates it consistently reduces cochlear damage. Both robotic and manual methods are safe, but the robotic method may offer more reliable results in preserving hearing. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need cochlear implants and have low-frequency pure-tone averages (LFPTA) at certain pitches below 80dB, indicating moderate to profound hearing loss. It's not suitable for those with conditions that may exclude them from the study.

Inclusion Criteria

My hearing loss at low frequencies is not severe.

I am over 18 and a candidate for a cochlear implant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo cochlear implant surgery using either robotic-assisted or manual insertion techniques

1 day

1 visit (in-person)

Activation

Cochlear implant devices are activated and initial impedance measurements are taken

6-8 weeks post-op

1 visit (in-person)

Follow-up

Participants are monitored for hearing outcomes and device function, including speech recognition and hearing preservation

12 months

3 visits (in-person) at 3, 6, and 12 months post-activation

What Are the Treatments Tested in This Trial?

Interventions

• IotaSoft Robotic Insertion System
• Manual Cochlear Implant Insertion

Trial Overview The study compares robotic-assisted insertion of cochlear implants using the IotaSoft Robotic Insertion System versus manual surgical insertion. The aim is to evaluate which method leads to better hearing outcomes one year post-surgery.

How Is the Trial Designed?

Group I: Robotic-Assisted Cochlear Implant Insertion Experimental Treatment 1 Intervention

Surgical technique using robotic assistance (IotaSoft system) to perform the cochlear implant electrode array insertion into the cochlea.

Group II: Manual Cochlear Implant Insertion Active Control 1 Intervention

Standard surgical technique for inserting the cochlear implant electrode array without robotic assistance. This represents the standard of care method.

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07081542

Comparative Analysis of Hearing Outcomes: Robotic vs. ... The IotaSoft robotic insertion device is an FDA-approved tool designed to provide precise and controlled insertion of the cochlear implant electrode array to ...

2. iotamotion.com iotamotion.com/

iotaMotion: Cochlear Implant Insertion Technology Simplified Intuitive cochlear implant insertion technology to improve standardized outcomes for every patient and every procedure. Learn more here.

3. 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.

4. news.ohsu.edu news.ohsu.edu/2024/01/24/small-robot-makes-big-difference-for-cochlear-implant-patient

Small robot makes big difference for cochlear implant patient The iotaSoft Insertion System uses a thumb-sized robot to precisely guide the placement of cochlear implants into the inner ear.

5. surgicalroboticstechnology.com surgicalroboticstechnology.com/news/iotamotion-surpasses-1000-clinical-procedures-performed-with-iotasoft/

iotaMotion Surpasses 1000 Clinical Procedures Performed ... Studies and surgeon feedback confirm the system reduces insertion force and variability, helping to reduce trauma, preserve delicate cochlear ...

6. prnewswire.com prnewswire.com/news-releases/iotamotion-surpasses-1-000-clinical-procedures-performed-with-iotasoft-defining-a-new-era-in-cochlear-implant-surgery-302566605.html

Defining a New Era in Cochlear Implant Surgery The iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System advances surgery beyond the limits of the human hand with slow, consistent, and ...

7. 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 ...