Phase
Condition
Hearing Loss
Deafness
Hearing Impairment
Treatment
Totally implantable cochlear Implant
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18 years or older, at time of consent
Candidate for cochlear implantation as assessed by the implanting clinic
Fluent in English, as determined by the investigator
Willing to participate in and comply with all requirements of the protocol
Willing and able to provide written informed consent
Exclusion
Exclusion Criteria:
Severe, or poorer, bilateral sensorineural hearing loss prior to five years of age,as reported by the subject
Duration of severe to profound hearing loss greater than 20 years in the ear to beimplanted as reported by the subject or by audiometric history, if available
Ossification, otosclerosis, malformation or any other cochlear anomaly, such ascommon cavity, that might prevent complete insertion of the electrode array
Deafness due to lesions of the acoustic nerve affecting the ear to be implanted
Medical or psychological conditions that would contraindicate undergoinganaesthesia, surgery or participation in the clinical investigation, as determinedby the investigator
Additional disabilities that may affect the subject's participation or safety duringthe clinical investigation, as determined by the investigator
Unrealistic expectations on the part of the subject regarding the possible benefits,risks and limitations that are inherent to the surgical procedure and prostheticdevice, as determined by the investigator
Desire to use an integrated acoustic component post-implantation
Unable or unwilling to comply with the requirements of the clinical investigation asdetermined 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
Cochlear employees or employees of Contract Research Organizations or contractorsengaged by Cochlear for the purposes of this investigation.
Current participation, or participation in another interventional clinicalstudy/trial in the past 30 days, involving an investigational drug or device (unlessCochlear sponsored and determined by investigator or Sponsor to not impact thisinvestigation)
Study Design
Connect with a study center
Royal Victoria Eye and Ear Hospital
Melbourne, Victoria 3002
AustraliaActive - Recruiting
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