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

Exclusion Criteria8

• 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.
• \. History of temporal bone fracture that involves the cochlea/internal auditory canal.
• \. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).
• \. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
• \. 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.
• \. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.
• \. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.
• \. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56