safety and effectiveness of cochlear implantation in an expanded adult population

Conditions: Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Summary: 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.


Eligibility criteria:
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.

Keywords: cochlear implant sensorineural hearing loss safety efficacy