Hearing Loss, SensorineuralAIMBOTNCT06664710
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
A study testing iotaSOFT Insertion System with AIM in people with Hearing Loss, Sensorineural and Cochlear Implantation, run by iotaMotion, Inc. at 1 site in United States.
Trial summary
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Cochlear Implantation
- What is being tested?
- iotaSOFT Insertion System with AIM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 18 years of age or older at the time of enrollment
- Willingness to participate in and comply with all requirements of the protocol
Who cannot join
- Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
- 4. History of temporal bone fracture that involves the cochlea/internal auditory canal.
- 5. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).
- 6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
- 7. 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.
- 8. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.
- 9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.
- 10. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Costa Nikou contact
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
About this study
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
Read the detailed description
The purpose of this study is to evaluate the feasibility and proof of concept of the integration of the AIM System and iotaSOFT Insertion System during cochlear implantation. Study results will help inform the need for future clinical investigations and data collection in the area of ECochG and robotic-assisted cochlear implantation.
- Conditions
- Hearing Loss, Sensorineural, Cochlear Implantation
- Being tested
- iotaSOFT Insertion System with AIM, iotaSOFT Insertion System with AIM Control
- Keywords
- cochlear implantation, sensorineural hearing loss, robotics
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iotaSOFT Insertion System with AIMDevice
Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop
iotaSOFT Insertion System with AIM ControlDevice
iotaSOFT Insertion System with AIM using standard of care insertion techniques
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Use of the iotaSOFT Insertion System and AIM based on Standard of Care Receives: Device: iotaSOFT Insertion System with AIM Control |
| Experimental | Experimental | Use of iotaSOFT Insertion System with AIM experimental device Receives: Device: iotaSOFT Insertion System with AIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Feasibility
Feasibility of device functionality intraoperatively at the time of cochlear implant surgery.
Measured: Procedure Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start17 Jan 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iotaMotion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664710
- Sponsor's protocol ID
- IAR2401
- Acronym
- AIMBOT
- Status last verified
- Jan 2025
- First submitted
- 15 Oct 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: To be determined based on the results of the study.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
- ClinicalTrials.gov ID
- NCT06664710
- Acronym / sponsor ID
- AIMBOT / IAR2401
- Conditions
- Hearing Loss, Sensorineural, Cochlear Implantation
- Keywords
- cochlear implantation, sensorineural hearing loss, robotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- iotaMotion, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
Detailed description
The purpose of this study is to evaluate the feasibility and proof of concept of the integration of the AIM System and iotaSOFT Insertion System during cochlear implantation. Study results will help inform the need for future clinical investigations and data collection in the area of ECochG and robotic-assisted cochlear implantation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: iotaSOFT Insertion System with AIM ControlUse of the iotaSOFT Insertion System and AIM based on Standard of Care |
| Experimental | Experimental | Device: iotaSOFT Insertion System with AIMUse of iotaSOFT Insertion System with AIM experimental device |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 18 years of age or older at the time of enrollment
- Willingness to participate in and comply with all requirements of the protocol
Key exclusion criteria (8 listed)
- Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
- 4. History of temporal bone fracture that involves the cochlea/internal auditory canal.
- 5. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).
- 6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
- 7. 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.
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 System with AIMExperimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop | Device | Experimental |
| iotaSOFT Insertion System with AIM ControliotaSOFT Insertion System with AIM using standard of care insertion techniques | Device | Control |
Primary outcome
Device Feasibility
Time frame: Procedure Day 0
Feasibility of device functionality intraoperatively at the time of cochlear implant surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Undecided. To be determined based on the results of the study.
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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.
Costa Nikou contact
1 site 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 with AIM in people with Hearing Loss, Sensorineural and Cochlear Implantation, run by iotaMotion, Inc. at 1 site 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Chenier, Director of Clinical Affairs, AuD (442-325-4171, lchenier@iotamotion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Feasibility (time frame: Procedure Day 0). 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 1 May 2025.