Robotics and ECochG System for Hearing Loss

(AIMBOT Trial)

Overseen By Costa Nikou

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: iotaMotion, Inc.

Disqualifiers: Cochlear abnormalities, Temporal bone fracture, Retrocochlear etiology, Middle-ear infection, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new system to assist with cochlear implant surgeries, which aim to improve hearing. Researchers are testing the iotaSOFT Insertion System with AIM, a robotic-assisted device, to determine if it offers better assistance than standard methods. The trial includes two groups: one using the standard system and the other using the experimental system. It seeks participants who are candidates for cochlear implants in one or both ears and have sufficient remaining hearing to use a specific hearing test. As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical advancements that could enhance hearing outcomes for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that this system is safe for cochlear implant surgery?

Research has shown that the iotaSOFT Insertion System with AIM is safe for use in cochlear implant surgeries. One study found that using a robot to assist in electrode insertion, a component of this system, preserved hearing in 85% of patients. This indicates that the technology is generally well-tolerated and prioritizes safety.

Although detailed safety data remain limited, the FDA has reviewed and approved the iotaSOFT system for use in cochlear implant procedures. This approval confirms that the system meets safety standards for assisting surgeons during surgeries. Overall, these findings suggest that the iotaSOFT Insertion System with AIM is a promising and safe option for patients considering cochlear implant surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iotaSOFT Insertion System with AIM because it introduces a new level of precision and control in cochlear implant procedures for hearing loss. Unlike traditional methods that rely heavily on the surgeon's skill, this system uses advanced robotics and an ECochG (electrocochleography) system to optimize implant placement, potentially improving outcomes and reducing risks. By integrating real-time feedback during surgery, the system aims to enhance the accuracy of electrode insertion, minimizing trauma to the cochlea and preserving residual hearing.

What evidence suggests that the iotaSOFT Insertion System with AIM is effective for cochlear implant surgery?

Studies have shown that the iotaSOFT Insertion System with AIM can help protect hearing during cochlear implant surgeries. In this trial, participants in the experimental arm will use the iotaSOFT Insertion System with AIM experimental device. Research indicates that robotic assistance in placing the electrodes (the part of the device that stimulates the hearing nerve) helps preserve hearing in about 85% of cases. Most patients, therefore, retain their hearing after surgery. Additionally, this system has been used successfully in over 1,000 surgeries, consistently yielding positive results. The technology allows surgeons to control the speed and depth of implant insertion, leading to better outcomes compared to manual insertion. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need cochlear implants and have enough residual hearing for electrocochleography. Candidates must be eligible for the Advanced Bionics SlimJ electrode array implantation. Exclusions include those with retrocochlear issues, active ear infections, participation in other conflicting trials, certain medical or anatomical ear conditions that prevent safe implantation, prior implants in the same ear, or unrealistic expectations.

Inclusion Criteria

Cochlear implant candidate in one or two ears per current FDA indications

Sufficient residual hearing to support use of electrocochleography, as determined by the investigator

Cochlear implantation using the Advanced Bionics SlimJ electrode array

Exclusion Criteria

My hearing loss is due to a nerve-related issue.

Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation

Additional medical concerns that would prevent participation in evaluations as determined by the investigator

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 using the iotaSOFT Insertion System and AIM system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the cochlear implant surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iotaSOFT Insertion System with AIM

Trial Overview The study tests a robotic system called iotaSOFT Insertion System with AIM during cochlear implant surgery. It aims to see how well this automated system integrates with ECochG (electrocochleography) to potentially improve surgical outcomes and patient safety.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Use of iotaSOFT Insertion System with AIM experimental device

Group II: Control Active Control 1 Intervention

Use of the iotaSOFT Insertion System and AIM based on Standard of Care

Who Is Running the Clinical Trial?

iotaMotion, Inc.

Lead Sponsor

Trials

4

Recruited

110+

Citations

1. 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04577118

NCT04577118 | The iotaSOFT Insertion System Safety Study The iotaSOFT Insertion System is a surgical device that aids the surgeon in implanting cochlear electrode arrays by controlling the speed and distance of ...

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

Robotic-Assisted Electrode Array Insertion Improves Rates ... Robotic-assisted EA insertion enhances structure and functional preservation—our results show the rate of hearing preservation to be 85% with robotic-assisted ...

4. morningstar.com morningstar.com/news/pr-newswire/20250925cg82762/iotamotion-surpasses-1000-clinical-procedures-performed-with-iotasoft-defining-a-new-era-in-cochlear-implant-surgery

Defining a New Era in Cochlear Implant Surgery The iotaSOFT Insertion System has been integrated into both academic and private practice settings with consistently positive results. "This ...

5. 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.

6. withpower.com withpower.com/trial/phase-hearing-loss-4-2022-7f23a

iotaSOFT Device for Hearing Loss · Info for Participants While specific data on the iotaSOFT Device is not available, these studies suggest that safety evaluations are a critical part of the development and monitoring ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN190055.pdf

DEN190055 Decision Summary - accessdata.fda.gov Data was provided to support the safe and effective use of iotaSOFT to assist in the insertion of the above cochlear implant electrode arrays (i.e., cochlear ...