Post-Market Clinical Investigation of the IotaSOFT Insertion System

Eligibility Criteria

• 1. Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below:
• 1. Advanced Bionics HiFocus SlimJ
• 2. Cochlear Slim Straight
• 3. MED-EL Flex 24 and 28
• 2. Age 12 years or older at the time of CI surgery.
• 3. Willingness to participate in the study and able to comply with the follow-up visit requirements.
• 1. Prior cochlear implantation in the ear to be implanted.
• 2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
• 3. Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g., fibrosis, fracture, or ossification), or cochlear malformations.
• 4. Deafness due to lesions of the acoustic nerve or central auditory pathway.
• 5. Diagnosis of auditory neuropathy.
• 6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
• 7. Absence of cochlear development.
• 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. Non-native English speakers who are unable to read, understand and/or speak English for completion of required procedures
• 11. Planned or current participation in a clinical study of an investigational device or drug.
• 12. Must not fit the definition of a vulnerable subjects, as per FDA regulations 21 CFR Parts 50 and 56