CP1110 Sound Processor Feasibility

Study Overview
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Brief Summary
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The clinical study aims to investigate the speech performance with the CP1110 Sound Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction feature in the Automatic Scene Classifier..

Detailed Description
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The study will build on the evidence previously collected on behind-the-ear sound processors and noise reduction, with particular focus on the speech perception performance of the CP1110 Sound Processor when compared to the CP1000 Sound Processor. To assess the primary and secondary speech perception objectives, the study incorporates a within-subject repeated-measures design in which each subject will undergo in-booth speech perception testing with all combinations of hardware and signal processing settings in a sound booth. The average difference scores will indicate the performance difference for each of the paired comparisons.

Official Title
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A Pre-Marketing, Prospective, Multi-Site, Open-Label, Within-Subject, Feasibility, Interventional Study of Speech Perception With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor and Compared With the CP1000 Sound Processor

Conditions
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Adult Cochlear Implant Recipients

Intervention / Treatment
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* Device: CP1110
* Device: CP1000


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 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or 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: Single Group Assignment
Interventional Model Description: prospective, pre-market, Multi-site, non-randomized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP1110 Sound Processor<br> | Device: CP1110<br>* Sound Processor<br>|
| Active Comparator: CP1000 Sound Processor.<br> | Device: CP1000<br>* Sound Processor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy measure for the CP1110 Sound Processor will be Speech Reception Thresholds (SRT) assessed via sentence scores in spatially separated adaptive noise | Paired difference in dB SRT between treatment and control, with their applicable noise reduction feature enabled. The speech recognition threshold (SRT) examines at which level the participant can repeat 50% of the speech material correctly. These scores may be negative or positive numeric values. Lower dB SRT scores indicate a better outcome. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy measures will be the percentage words correct as assessed by CNC (Consonant Nucleus Consonant) Monosyllabic word scores in quiet. | Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. | One day |