A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults

Inclusion Criteria: * Individuals aged 18 years and older at time of consent. * Clinically established sensorineural hearing loss (SNHL) defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥70 dB HL in the ear to be implanted. * Compromised functional hearing in the aided condition defined as ≤40% correct on a word recognition test in the ear to be implanted. * Clinically established SNHL defined by a four-frequency (500, 1000, 2000 \& 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥30 dB HL in the contralateral ear. * Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator. * Direct access to a compatible Smart Phone. * Willing and able to provide written informed consent. Exclusion Criteria: * Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted. * Candidates with single-sided deafness as determined by the investigator. * 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. * Presence of a tympanic membrane perforation or a history of otologic surgery within…