A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults

Inclusion criteria

• Aged 18 years or older (at time of consent).
• Clinically established post-linguistic moderately severe to profound sensorineural hearing loss, in the ear to be implanted.
• Compromised functional hearing with hearing aid(s) or unlikely to receive benefit with hearing aid(s) in the ear to be implanted.
• Cochlear implant candidate as determined by the Principal Investigator. Meets local candidacy criteria for cochlear implantation.
• Candidate is a fluent speaker in the language used to assess speech perception performance.
• Willing and able to comply with study follow-up schedule.
• Willing and able to provide written informed consent.
• Candidate has access to a Smartphone compatible with Nucleus Smart App.

Exclusion criteria

• Prior cochlear implantation in the ear to be implanted.
• Unrealistic expectations regarding the possible benefit, risks and limitations that are inherent to the surgical procedure and prosthetic device as determined by the investigator.
• Any contraindications for cochlear implantation listed in the relevant product physician's guide (to be specified per sub-investigation).
• 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.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
• Women who are pregnant.
• Current participation, or participation in an 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).