Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients.

Study Overview
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Brief Summary
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The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN'.

Detailed Description
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The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN'. This study will build on the evidence collected in previous Nucleus 7 Sound Processor take home studies and will also aim to confirm the in-booth performance of CP1110 and Nucleus 7 Sound Processors.

Official Title
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A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Actual-Use, Interventional Study of Acceptance and Performance With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor Compared With the CP1000 Sound Processor

Conditions
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Adult Cochlear Implant Recipients

Intervention / Treatment
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* Device: CP1110 Sound Processor System
* Device: Nucleus 7 Sound Processor (model: CP1000) system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older. Post lingually deafened. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422). At least 6 months experience with a cochlear implant. At least 3 months experience with a Nucleus 7 (CP1000) Sound Processor Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test Willingness to participate in and to comply with all requirements of the protocol. Fluent speaker in English as determined by the investigator Willing and able to provide written informed consent Exclusion Criteria: 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. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. Currently participating, or participated in another interventional clinical study/trial in the past 30 days or if less than 30 days, the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, pre-market, single-site, non-randomized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP1110 Sound Processor System with ForwardFocus On (SCAN)<br> | Device: CP1110 Sound Processor System<br>* Sound Processor<br>|
| Experimental: CP1110 Sound Processor System with ForwardFocus Off (SCAN)<br> | Device: CP1110 Sound Processor System<br>* Sound Processor<br>|
| Active Comparator: Nucleus 7 Sound Processor (model: CP1000) system<br> | Device: Nucleus 7 Sound Processor (model: CP1000) system<br>* Sound Processor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Reception Thresholds (SRT) assessed in spatially separated speech and noise (S0Nrearhalf). | Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with ForwardFocus ON (SCAN) and ForwardFocus OFF (SCAN) (65 dB SPL S0Nrearhalf 4TB). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Reception Thresholds (SRT) assessed in spatially separated speech and noise (S0N3). | Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with ForwardFocus On (SCAN) and ForwardFocus OFF (SCAN) (65 dB SPL S0N3 Babble). | 6 months | 
| Adult cochlear implant speech perception in quiet with the CP1110 Sound Processor and the Nucleus 7 Sound Processor. | Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound Processor and Nucleus 7 Sound Processor. | 6 months | 
| Adult cochlear implant subjective hearing performance and sound quality with the CP1110 Sound Processor and Nucleus 7 Sound Processor. | Paired difference in Global Speech, Spatial and Qualities of Hearing Scale SSQ12 scores after experience with the CP1110 Sound Processor and Nucleus 7 Sound Responses on the SSQ12 have a minimum value of 0 and a maximum of 10, wherein a higher score means a better outcome. | 6 months | 
| To evaluate acceptance and satisfaction of the CP1110 Sound Processor. | Responses on the 'CP1110 Questionnaire 1' after at least 2 weeks of experience with the CP1110 Sound Processor and 'CP1110 Questionnaire 2' up to 6 months later. | 6 months |