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Robot arm aims to improve cochlear implant surgery for kids

NCT ID NCT06106373

Symptom relief Sponsor: iotaMotion, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tested a robotic device called iotaSOFT that helps surgeons insert cochlear implants into the ears of children with hearing loss. Twenty children aged 9 months to 12 years took part. The goal was to see if the robot is safe and works well. Researchers tracked any problems for 30 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iotaSOFT Insertion System (robotic assistive device for cochlear implant surgery)
What this could lead to
If successful, this robotic tool could make cochlear implant surgery safer and more precise for children, potentially improving hearing outcomes.
What could go wrong
This was a small, early study with only 20 children and no comparison group. The device may not work better than standard manual insertion, and there is a risk of surgical complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

May 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 months to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Candidate for unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices * Age 9 months to less than 12 years old at the time of CI surgery * Willingness to participate in the study and able to comply with the follow-up visit requirements Exclusion Criteria: * Prior cochlear implantation in the ear to be implanted * Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion * Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations * Deafness due to lesions of the acoustic nerve or central auditory pathway * Diagnosis of auditory neuropathy. * Active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease * Absence of cochlear development * Additional medical concerns that would prevent participation in evaluations as determined by the investigator * Planned or current participation in a clinical study of an investigational device or drug

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Conditions

The condition(s) this trial relates to.

deafness, unilateral hearing loss disorder Hearing Loss, Bilateral Hearing Loss, Sensorineural Hearing Loss, Unilateral sensorineural hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hearing loss, bilateral Hearing loss, sensorineural Hearing loss, unilateral

Contacts and locations

Locations

  • Texas Childrens Hospital

    Houston, Texas, 77030, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.