Brief Title
Clinical Evaluation of a Cochlear Implant System
Official Title
Clinical Evaluation of a Cochlear Implant System
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.
Study Type
Interventional
Primary Outcome
Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.
Secondary Outcome
Speech perception performance of the CP1000 Sound Processor in quiet and in noise.
Condition
Sensorineural Hearing Loss
Intervention
Nucleus 7 Cochlear Implant System
Study Arms / Comparison Groups
Cochlear implant users
Description: This is a within-subject, repeated measures study. There was one arm in this study, each subject served as their own control. All subjects received all interventions.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
46
Start Date
July 1, 2016
Completion Date
September 7, 2017
Primary Completion Date
September 7, 2017
Eligibility Criteria
Inclusion Criteria:
1. Eighteen years of age or older
2. At least 6 months experience with a Nucleus 24 series or later implant in at least one
implanted ear
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Fluent speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
Exclusion Criteria:
1. Unrealistic expectations on the part of the subject, regarding the possible benefits,
risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Nucleus 22 Implant
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Mary Beth Brinson, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT03467399
Organization ID
CLTD5620
Responsible Party
Sponsor
Study Sponsor
Cochlear
Study Sponsor
Mary Beth Brinson, Principal Investigator, Cochlear Ltd
Verification Date
March 2018