Hearing Loss, SensorineuralNCT06106373
iotaSOFT Pediatric Study
A study testing iotaSOFT Insertion System in people with Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by iotaMotion, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
- What is being tested?
- iotaSOFT Insertion System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 May 2022to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Childrens Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
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.
- Being tested
- iotaSOFT Insertion System
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iotaSOFT Insertion SystemDevice
robotic assistive technology for cochlear implant electrode insertion
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Cochlear Implant Recipient | Experimental | 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 Receives: Device: iotaSOFT Insertion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (SAEs) through 30 days after CI surgery/activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start17 May 2022
- Primary completion24 Oct 2024
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- iotaMotion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Chenier, Study director, iotaMotion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106373
- Sponsor's protocol ID
- iotaSOFT000002
- Status last verified
- Jul 2026
- First submitted
- 24 Oct 2023
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
- ClinicalTrials.gov ID
- NCT06106373
- Acronym / sponsor ID
- iotaSOFT000002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- iotaMotion, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Cochlear Implant Recipient | Experimental | Device: iotaSOFT Insertion SystemPediatric 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 |
Who may qualify
- Ages
- 9 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iotaSOFT Insertion Systemrobotic assistive technology for cochlear implant electrode insertion | Device | Pediatric Cochlear Implant Recipient |
Primary outcome
iotaSOFT Related-serious Adverse Events Measured by Calculating the Proportion of Subjects With One or More SAEs.
Time frame: (SAEs) through 30 days after CI surgery/activation
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Chenier study director
iotaMotion, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iotaSOFT Insertion System in people with Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by iotaMotion, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iotaSOFT Related-serious Adverse Events Measured by Calculating the Proportion of Subjects With One or More SAEs. (time frame: (SAEs) through 30 days after CI surgery/activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.