Clinical Research Directory

Inclusion Criteria: * Aged 18 years or older (at time of consent) * Clinically established post-linguistic bilateral moderately severe to profound sensorineural hearing loss * Meets local candidacy criteria for cochlear implantation * Compromised functional hearing with a hearing aid in the ear to be implanted * Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm * Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines prior to randomisation * Candidate is proficient in the language used to assess speech perception performance * Willing and able to provide written informed consent. 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.