Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

A Pivotal, Prospective, Open-label, Multi-center Study of Safety and Effectiveness of Cochlear Implantation in an Expanded Population of Adults With Bilateral Sensorineural Hearing Loss

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.

Inclusion Criteria:

• Individuals 18 or older at the time of consent
• Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, & 4000 Hz of: ≥60 dB HL and compromised functional hearing 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 perception performance as determined by the investigator.
• Willing and able to provide written informed consent.

Exclusion Criteria:

• Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and 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 the ear 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 contralateral cochlear implant during the clinical investigation.
• Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation.
• Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator.
• Additional disabilities that may affect the participant's participation of safety during the clinical investigation.
• Unable or unwilling to comply with all of 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 a spouse, parent, child, or sibling.
• Employees of Cochlear.
• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.