Status:
COMPLETED
Clinical Evaluation of a Cochlear Implant System
Lead Sponsor:
Cochlear
Conditions:
Sensorineural Hearing Loss
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The primary objective of this study is to assess the usability of a Cochlear implant system.
Detailed Description
Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.
Eligibility Criteria
Inclusion
- Eighteen years of age or older
- At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
- At least 3 months experience with the CP810,CP920 or CP910 sound processor
- Fluent speaker in the language used to assess speech perception performance
- Willingness to participate in and to comply with all requirements of the protocol
- Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
Exclusion
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
- Additional disabilities that would prevent participation in evaluations
- Nucleus 22 Implant
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03467399
Start Date
July 1 2016
End Date
September 7 2017
Last Update
March 16 2018
Active Locations (1)
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1
Cochlear Ltd
Sydney, New South Wales, Australia, 2109