A Pre-market, Prospective, Interventional, Multicenter, Pivotal Study to Evaluate Efficacy and Safety of a Totally Implantable Cochlear Implant System in an Adult Population With Sensorineural Hearing Loss
This clinical study examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment allowing the option to hear without the need of an external sound processor. This implant will be tested in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing and overall general health.
• Individuals aged 18 years and older at time of consent.
• Clinically established post-linguistic moderately severe to profound sensorineural hearing 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, as determined by the investigator.
• Willing to undergo unilateral cochlear implantation.
• 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.