NCT06664710 Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
| NCT ID | NCT06664710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iotaMotion, Inc. |
| Condition | Hearing Loss, Sensorineural |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-01-17 |
| Primary Completion | 2025-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-01-17 with a primary completion date of 2025-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
Eligibility Criteria
Inclusion Criteria: 1. Cochlear implant candidate in one or two ears per current FDA indications 2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator 3. Cochlear implantation using the Advanced Bionics SlimJ electrode array 4. 18 years of age or older at the time of enrollment 5. Willingness to participate in and comply with all requirements of the protocol Exclusion Criteria: 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06664710 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Hearing Loss, Sensorineural. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06664710 currently recruiting?
Yes, NCT06664710 is actively recruiting participants. Contact the research team at lchenier@iotamotion.com for enrollment information.
Where is the NCT06664710 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT06664710 clinical trial?
NCT06664710 is sponsored by iotaMotion, Inc.. The trial plans to enroll 10 participants.