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Procedure

Robotics and ECochG System for Hearing Loss (AIMBOT Trial)

N/A
Waitlist Available
Research Sponsored by iotaMotion, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older at the time of enrollment
Must not have
Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway)
Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedure day 0
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new system that combines robotics and ECochG technology to assist with cochlear implant surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of using the iotaSOFT Insertion System are not detailed here, typical risks may include those associated with cochlear implant surgery such as infection risk at the site of surgery, inflammation around the implanted area, possible damage to nearby structures within the ear during insertion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My hearing loss is due to a nerve-related issue.
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I have an active ear infection or a ruptured eardrum with ongoing ear disease.
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I have a cochlear condition that may affect surgery.
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I have had a fracture in the bone surrounding my inner ear.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure day 0
This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure day 0 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device Feasibility

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Use of iotaSOFT Insertion System with AIM experimental device
Group II: ControlActive Control1 Intervention
Use of the iotaSOFT Insertion System and AIM based on Standard of Care

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Who is running the clinical trial?

iotaMotion, Inc.Lead Sponsor
3 Previous Clinical Trials
95 Total Patients Enrolled
~7 spots leftby Jun 2025
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