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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the integration of the AIM System with the iotaSOFT Insertion System to assist cochlear implant surgery for patients with sensorineural hearing loss. This study aims to test the feasibility and proof of concept of combining robotic technology and electrocochleography (ECochG) during cochlear implantation. The results will guide future clinical studies and data collection in this area. Participants will undergo cochlear implantation using the Advanced Bionics SlimJ electrode array. Two study groups are included: one group will receive the standard of care using the iotaSOFT Insertion System with AIM, and the other group will receive the experimental treatment using the iotaSOFT Insertion System with AIM controlled robotically. The study is non-randomized and does not involve masking or blinding. During the procedure day (Day 0), researchers will assess device feasibility. Participants must comply with all protocol requirements and will be monitored for any medical concerns that could affect participation. The study involves patients 18 years and older who are candidates for cochlear implantation and have sufficient residual hearing to support ECochG.
CONDITIONS
Brief 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...
- 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
You will not qualify if you...
- Contraindications for cochlear implant
- Prior cochlear implantation in the ear to be implanted
- Cochlear ossification or malformation, craniofacial abnormality, or other structural cochlear abnormalities preventing electrode insertion or increasing risk
- History of temporal bone fracture involving the cochlea or internal auditory canal
- Retrocochlear etiology such as auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway
- Active middle-ear infection or tympanic membrane perforation with active middle ear disease
- Current or planned participation in another clinical study that may impact data or outcomes
- Additional medical concerns preventing participation as determined by the investigator
- Unrealistic expectations regarding benefits, risks, and limitations of the procedure and device
- Vulnerable subject as defined by FDA regulations 21 CFR Parts 50 and 56
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure Day 0
Participants receive cochlear implantation using either the experimental iotaSOFT Insertion System with AIM robotic controlled stop or the standard of care insertion technique.
1 visit (in-person)
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
C
Costa Nikou
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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