About this trial
The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in adults with cochlear implants.
The study will include two groups of adult cochlear implant recipients: veterans and non-veterans. Comparing these groups will help researchers understand how these sound processors perform in veteran populations as well as the broader adult cochlear implant community.
Participants will use each sound processor and then take part in speech understanding tests in background noise. They will also complete questionnaires about their listening experiences with each processor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older, at time of consent.
Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24R(CA), CI24R(ST) CI24R(CS), CI24M, CI24RE(CA), CI24RE(ST), CI422) in the test ear.
At least 18 active electrodes in the test ear.
At least 6 months experience with a cochlear implant in the test ear.
Disqualifiers
Recipients with single-sided deafness as determined by the Investigator.
Additional disabilities that would prevent participation in evaluations.
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
Trial design
Crossover
Treatments tested in this trial
Nucleus 7 Sound Processor
DeviceWhile the user can turn ForwardFocus on from any program in the Nucleus 7 Sound Processor, for the duration of this study, SCAN will be used as the default program and ForwardFocus will be turned on for testing. This setting will be referred to as SCAN ForwardFocus (SCAN FF).
Nucleus 8 Sound Processor
DeviceNucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance.
Treatment groups
Trial outcomes
Primary outcomes
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N90 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Secondary outcomes
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S90N180 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N180 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Paired difference in AzBio improvement (percentage-point change) for the Nucleus 8 Sound Processor (SCAN 2 FF minus SCAN 2) compared to the Nucleus 7 Sound Processor (SCAN FF minus SCAN) in the S0N180 spatial configuration
The AzBio sentence test is a validated test used to assess open-set sentence recognition. AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
Paired difference in CNC percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration
The consonant-nucleus-consonant (CNC) monosyllabic word test will be used to assess speech perception of words in quiet. The test consists of 10 recorded lists of 50 monosyllabic words, produced by a male talker.
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