Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)

Exclusion Criteria

• •Planned for a partial insertion of the electrode array
• •Intra-axial (within the brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted
• •Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment
• •Active autoimmune disease or active immunosuppressive therapy
• •Any of the following in the ear to be implanted within 3 months prior to enrolment: history of prior otologic surgery including grommets, or tympanic membrane perforation
• •Previously reported diagnosis of auditory neuropathy, in the ear to be implanted
• •Previously reported diagnosis, in the ear to be implanted, of Large Vestibular Aqueduct Syndrome (LVAS), Meniere's disease, or cochlear hydrops
• •Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by imaging, in the ear to be implanted
• •Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, temporo- parietal skull fracture or CSF leaks
• •History of bacterial meningitis
• •Known allergic reaction or contraindication to dexamethasone or corticosteroids
• •Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the subject
• •Severe, or poorer, sensorineural hearing loss of more than 20 years, as reported by the subject, in the ear to be implanted
• •Prior cochlear implantation, in either ear
• •Medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted
• •Medical or psychological conditions that contraindicate general anaesthesia, surgery or participation in the clinical investigation, as determined by the investigator
• •Women who are pregnant
• •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
• •Additional disabilities that may affect the subject's participation or safety during the clinical investigation, as determined by the Investigator
• •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
• •Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child, or sibling to the study candidate
• •Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
• •Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by investigator or Sponsor to not impact this investigation)
• •Subjects recruited at a French site who are not affiliated with social security
• •Subjects recruited at a French site who are under legal protection.