Actively Recruiting
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Led by iotaMotion, Inc. · Updated on 2025-05-01
10
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
CONDITIONS
Official Title
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidate for cochlear implant in one or two ears according to current FDA indications
- Sufficient residual hearing to support electrocochleography as determined by the investigator
- Undergoing cochlear implantation with the Advanced Bionics SlimJ electrode array
- 18 years of age or older at enrollment
- Willing to participate and comply with all protocol requirements
You will not qualify if you...
- Contraindications for cochlear implant
- Prior cochlear implantation in the ear to be implanted
- Cochlear ossification, malformation, or craniofacial abnormalities that prevent complete electrode insertion or increase risk
- History of temporal bone fracture involving cochlea or internal auditory canal
- Retrocochlear causes such as auditory neuropathy or cochlear nerve deficiency
- Active middle-ear infection or tympanic membrane perforation with active middle ear disease
- Current or planned participation in another investigational device or drug study affecting data
- Other medical issues preventing participation as determined by investigator
- Unrealistic expectations about benefits, risks, and limitations of the procedure and device
- Vulnerable subjects as defined by FDA regulations 21 CFR Parts 50 and 56
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
L
Laura Chenier, Director of Clinical Affairs, AuD
CONTACT
C
Costa Nikou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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