Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

Inclusion Criteria:

• Individuals 18 or older at the time of consent

• Meets the following audiometric criteria for the ear to be implanted: clinicallyestablished sensorineural hearing loss (SNHL) defined by a four frequency pure toneaverage (PTA) at 500, 1000, 2000, & 4000 Hz of: ≥60 dB HL and compromised functionalhearing in the aided condition defined as <50% correct on a word recognition test

• Meets the following audiometric criteria for the non-implanted contralateral ear:clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, & 4000 Hz of >30 dB HL

• Candidate is a fluent speaker in the language used to assess speech perceptionperformance as determined by the investigator.

• Willing and able to provide written informed consent.

Exclusion Criteria:

• Meets current indications on audiometric thresholds for traditional adult CIcandidates (i.e., bilateral moderate to profound hearing loss in the low frequenciesand profound [≥ 90 dB HL] hearing loss in the mid to high speech frequencies)

• Absence of cochlea development or a cochlear nerve

• Presence of active middle ear infection in the ear to be implanted

• Tympanic membrane perforation in the presence of active middle ear disease in theear to be implanted

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

• Existing contralateral cochlear implant or medical plan to implant a contralateralcochlear implant during the clinical investigation.

• Pregnant or breastfeeding women. Women who plan to become pregnant during the courseof the clinical investigation.

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

• Additional disabilities that may affect the participant's participation of safetyduring the clinical investigation.

• Unable or unwilling to comply with all of the requirements of the clinicalinvestigation as determined by the investigator.

• Investigator site personnel directly affiliated with this study and/or theirimmediate families; immediate family is defined as a spouse, parent, child, orsibling.

• Employees of Cochlear.

• Current participation, or participation in another interventional clinicalstudy/trial in the past 30 days, involving an investigational drug or device (unlessthe other investigation was/is a Cochlear sponsored investigation and determined bythe investigator or Sponsor to not impact this investigation.