Post-Market Clinical Investigation of the IotaSOFT Insertion System

Exclusion Criteria12

• Prior cochlear implantation in the ear to be implanted.
• Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
• Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g., fibrosis, fracture, or ossification), or cochlear malformations.
• Deafness due to lesions of the acoustic nerve or central auditory pathway.
• Diagnosis of auditory neuropathy.
• Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
• Absence of cochlear development.
• 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.
• Non-native English speakers who are unable to read, understand and/or speak English for completion of required procedures
• Planned or current participation in a clinical study of an investigational device or drug.
• Must not fit the definition of a vulnerable subjects, as per FDA regulations 21 CFR Parts 50 and 56