Cochlear Implantation, Hearing Loss, Sensorineural
Conditions
Keywords
cochlear implantation, sensorineural hearing loss, robotics
Brief summary
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
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.
Interventions
DEVICEiotaSOFT Insertion System with AIM
Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop
DEVICEiotaSOFT Insertion System with AIM Control
iotaSOFT Insertion System with AIM using standard of care insertion techniques
Sponsors
iotaMotion, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Feasibility | Procedure Day 0 | Feasibility of device functionality intraoperatively at the time of cochlear implant surgery. |
Countries
United States
Contacts
Primary ContactLaura Chenier, Director of Clinical Affairs, AuD
Backup ContactCosta Nikou
Outcome results
None listed