A Pivotal Study to Evaluate the Efficacy 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 post-linguistic moderately severe to profound sensorineuralhearing loss (PTA4 of >55 dB HL), in the ear to be implanted.

• Meets local candidacy criteria for cochlear implantation.

• Compromised functional hearing with a hearing aid in the ear to be implanted, asdetermined by the investigator.

• Willing to undergo unilateral cochlear implantation.

• Candidate is a fluent speaker in the language used to assess speech perceptionperformance 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 cochlearimplantation during the clinical investigation, contralateral to the ear to beimplanted.

• Candidates with single-sided deafness as determined by the investigator.

• Intra-axial (within-the-brain) lesions or deafness due to lesions of the acousticnerve 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 atthe time of surgery or within 3 months prior to enrolment.

• Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.

• Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.

• Cochlear ossification, cochlear malformation or any other cochlear anomaly, such ascommon cavity, that might prevent complete insertion of the electrode array, in theear to be implanted.

• Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula,skull fracture or CSF leaks.

• Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, asreported by the participant.

• Severe, or poorer, sensorineural hearing loss for more than 20 years, as reported bythe participant, in the ear to be implanted.

• Medical or psychological conditions that contraindicate general anaesthesia,surgery, or participation in the clinical investigation as determined by theinvestigator.

• Preexisting skin condition that could jeopardize wound healing, as determined by theinvestigator e.g., psoriasis, dermatitis, use of corticosteroids, uncontrolleddiabetes.

• Unrealistic expectations on the part of the participant, regarding the possiblebenefits, risks, and limitations inherent to the surgical procedure(s) andprosthetic devices, as determined by the Investigator.

• Additional disabilities that may affect the subject's participation or safety duringthe clinical investigation.

• Women who are pregnant.

• Investigator site personnel directly affiliated with this study and/or theirimmediate families. Immediate family is defined as spouse, parent, child or sibling.

• Cochlear employees or employees of Contract Research Organisations or contractorsengaged by Cochlear for the purposes of the investigation.

• Current participation, or participation in another interventional clinicalstudy/trial in the past 30 days, involving an investigational drug or device.

• Unable or unwilling to comply with the requirements of the clinical investigation asdetermined by the Investigator (unless Cochlear sponsored and determined byInvestigator or Sponsor to not impact this investigation).