Clinical Evaluation of a Cochlear Implant System

Study Overview
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Brief Summary
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The primary objective of this study is to assess the usability of a Cochlear implant system.

Detailed Description
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Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.

Official Title
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Clinical Evaluation of a Cochlear Implant System

Conditions
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Sensorineural Hearing Loss

Intervention / Treatment
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* Device: Nucleus 7 Cochlear Implant System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cochlear implant users<br>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. | Device: Nucleus 7 Cochlear Implant System<br>* A new cochlear implant sound processor system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Non-inferiority of subjects' overall satisfaction ratings for the CP1000 Sound Processor and related components measured following 3 months of use, compared to subjects' overall satisfaction rating for their own Sound Processor and related components measured at study onset. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech perception performance of the CP1000 Sound Processor in quiet and in noise. | Data to substantiate the speech perception scores of the subjects for different quiet and noise conditions for different configurations of sound processor and / or accessories. | One year |