Phase
Condition
Hearing Impairment
Hearing Loss
Deafness
Treatment
Focused stimulation strategy
ACE stimulation strategy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults 18 years of age or older.
Candidate for unilateral cochlear implant with Slim Modiolar electrode array asdetermined by the implanting centre.
English spoken as a primary language.
Willingness to comply with all investigational requirements.
Willing and able to provide written informed consent.
Exclusion
Exclusion Criteria:
Previous or existing cochlear-implant recipient.
Evidence of severe or greater sensorineural hearing loss prior to five years of age.
Open-set pre-operative word score > 70% in the contralateral ear.
Duration of severe to profound hearing loss > 20 years in the ear to be implanted.
Adults with functional acoustic hearing in the ear to be implanted who desire to usean acoustic component in the implanted ear.
Ossification or other cochlear anomaly that might prevent complete insertion of theelectrode array.
Hearing loss of neural or central origin.
Medical or psychological conditions that would contraindicate undergoing surgery.
Women who are pregnant.
Additional handicaps that would prevent or restrict participation in theaudiological evaluations.
Unrealistic expectations on the part of the subject regarding the possible benefits,risks, and limitations that are inherent to the surgical procedure and prostheticdevice.
Inability or unwillingness to use a hand-held device to control the sound processorand to collect test and survey data.
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 Organisations or contractorsengaged by Cochlear for the purposes of this investigation.
Currently participating, or participated within the last 30 days, in anotherinterventional clinical investigation/trial involving an investigational drug ordevice.
Study Design
Study Description
Connect with a study center
NextSense - Deakin
Deakin, Australian Capital Territory 2600
AustraliaSite Not Available
NextSense - Broadmeadow
Broadmeadow, New South Wales 2292
AustraliaSite Not Available
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria 3002
AustraliaSite Not Available
St Vincent's Private Hospital
East Melbourne, Victoria 3002
AustraliaSite Not Available

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