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

Trial Summary

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 data supports the effectiveness of the treatment iotaSOFT Insertion System with AIM for hearing loss?

Research shows that using robotics and electrocochleography (ECochG) during cochlear implant surgery can help preserve hearing by allowing for more precise and less traumatic insertion of the implant. This approach has been shown to maintain residual hearing in patients, suggesting its potential effectiveness in treating hearing loss. ^{1 2 3 4 5}

Is the robotic-assisted cochlear implant insertion system safe for humans?

Research shows that robotic-assisted cochlear implant insertion systems, like the RobOtol® and others, have been used safely in humans, with surgeries being uneventful and preserving hearing in patients. These systems aim to reduce trauma during surgery and have shown promising results in maintaining hearing, although more studies are needed to confirm long-term safety and effectiveness. ^{1 2 3 4 5}

How is the iotaSOFT Insertion System with AIM treatment different from other treatments for hearing loss?

The iotaSOFT Insertion System with AIM is unique because it uses a robotic system to insert cochlear implant electrodes with precision, guided by real-time electrocochleography (ECochG) signals. This approach aims to reduce trauma during insertion and preserve residual hearing, which is not typically addressed by standard manual techniques. ^{1 2 3 6 7}

What is the purpose of this trial?

Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery

Eligibility Criteria

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.

I have an active ear infection or a ruptured eardrum with ongoing ear disease.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Robotics, automation, active electrode arrays, and new devices for cochlear implantation: A contemporary review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Development and Characterization of an Electrocochleography-Guided Robotics-Assisted Cochlear Implant Array Insertion System. [2023]

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

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

5. 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]

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

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

7. England pubmed.ncbi.nlm.nih.gov

An Optimized Robot-Based Technique for Cochlear Implantation to Reduce Array Insertion Trauma. [2019]