An interventional study of iotaSOFT Insertion System in Hearing Loss, Sensorineural, Hearing Loss, Bilateral and Hearing Loss, Unilateral, sponsored by iotaMotion, Inc.. Completed at 2 sites in United States. Open to participants aged 9 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by iotaMotion, Inc. · Not applicable, Interventional, and Treatment
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.
This study's enrollment of 20 is below the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →iotaMotion, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age who meet prescribed inclusion and exclusion criteria per protocol, signing and Informed Consent and completing active study period; enrollment through 30 days post cochlear implant surgery/activation per investigator site standard of care
Device: iotaSOFT Insertion System
robotic assistive technology for cochlear implant electrode insertion
iotaSOFT Related-serious Adverse Events Measured by Calculating the Proportion of Subjects With One or More SAEs.
The primary endpoint of the study was to demonstrate safety of the iotaSOFT Insertion System through evaluation of iotaSOFT related serious adverse events through 30 days after CI surgery/activation.
Time frame: (SAEs) through 30 days after CI surgery/activation
Study participants were identified and recruited by investigators from IDE/IRB-approved investigator sites. Those recruited were pediatric cochlear implant candidates pending implantation with one of the protocol-identified iotaSOFT-compatible electrode arrays.
| Milestone | Pediatric Cochlear Implant Recipient |
|---|---|
| Started | 20 |
| Cochlear implant surgery | 20 |
| Completed | 20 |
| Not completed | 0 |
The primary endpoint of the study was to demonstrate safety of the iotaSOFT Insertion System through evaluation of iotaSOFT related serious adverse events through 30 days after CI surgery/activation.
| Participants | Pediatric Cochlear Implant Recipient |
|---|---|
| iotaSOFT Related-serious Adverse Events Measured by Calculating the Proportion of Subjects With One or More SAEs. | 0 |
Collected over 30 days post-cochlear implant surgery/activation per investigator site standard of care.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pediatric Cochlear Implant Recipient | 0/20 (0%) | 1/20 (5%) | 6/20 (30%) |
| Event | Pediatric Cochlear Implant Recipient |
|---|---|
| swelling and purulent drainage from post-auricular incisionEar and labyrinth disorders | 1/20 |
| Event | Pediatric Cochlear Implant Recipient |
|---|---|
| strep positive throatInfections and infestations | 2/20 |
| vomiting and dizzinessEar and labyrinth disorders | 1/20 |
| drainage from surgical incisionEar and labyrinth disorders | 1/20 |
| postoperative painEar and labyrinth disorders | 1/20 |
| vomiting due to viral infectionGeneral disorders | 1/20 |
| Age, Continuous(years) | Pediatric Cochlear Implant Recipient |
|---|---|
| Mean | 5.7 (1.3 to 10.2) |
| Sex: Female, Male(Participants) | Pediatric Cochlear Implant Recipient |
|---|---|
| Female | 9 |
| Male | 11 |
| Race and Ethnicity Not Collected(Participants) | Pediatric Cochlear Implant Recipient |
|---|
| Region of Enrollment(participants) | Pediatric Cochlear Implant Recipient |
|---|---|
| United States | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
iotaMotion, Inc.