Purpose

Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery

Conditions

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Control
Use of the iotaSOFT Insertion System and AIM based on Standard of Care
  • Device: iotaSOFT Insertion System with AIM Control
    iotaSOFT Insertion System with AIM using standard of care insertion techniques
Experimental
Experimental
Use of iotaSOFT Insertion System with AIM experimental device
  • Device: iotaSOFT Insertion System with AIM
    Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop

Recruiting Locations

University of Iowa
Iowa City, Iowa 52242

More Details

NCT ID
NCT06664710
Status
Recruiting
Sponsor
iotaMotion, Inc.

Study Contact

Laura Chenier, Director of Clinical Affairs, AuD
442-325-4171
lchenier@iotamotion.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.