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Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Recruiting
Who can join
Ages 12 and older · All sexes
Full 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
About the study
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
What is being tested
- iotaSOFT Insertion System with AIM (device)
- iotaSOFT Insertion System with AIM Control (device)
Sponsor: iotaMotion, Inc. · Participants: 10 · Started: Jan 17, 2024
Contact the study team
- Laura Chenier, Director of Clinical Affairs, AuD · Phone: 442-325-4171
Official record on ClinicalTrials.gov — NCT06664710
Locations in the U.S.
| Iowa | University of Iowa, Iowa City |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.