Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (POLAR)

Study Overview
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Brief Summary
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Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.

Detailed Description
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This investigation is planned to investigate the performance and clinical benefits of features that are new to the CP 1170 Sound Processor. This study will build on the evidence previously collected on OTE (off the ear) sound processors and ForwardFocus, with particular focus on the acceptance and satisfaction of the automation of ForwardFocus in the CP1170 Sound Processor and associated components in general.

Official Title
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A Pre-market, Open-label, Within Subject Study, of Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients Compared With the CP1150 Sound Processor and Their Current Sound Processor.

Conditions
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Hearing Impairment

Intervention / Treatment
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* Device: CP1170 sound processor
* Device: CP1150 Sound processor


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); Freedom Series (CI24RE(CA), CI24RE(ST), CI422) or N24 Series (CIC3). At least 6 months experience with a cochlear hearing implant At least 3 months experience with any Nucleus sound processor and SCAN program 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, as determined by the Investigator. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact 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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP1170 sound processor<br>Take home use of CP1170 Sound processor for 2 weeks followed by in booth testing of the investigational device. | Device: CP1170 sound processor<br>* The CP 1170 sound processor will be used to determine the hearing performance with the new implementation of ForwardFocus in SCAN 2 (SCAN 2 FF), as assessed by speech perception in noise.<br>|
| Active Comparator: CP1150 sound processor<br>In booth testing of CP1150 sound processor. | Device: CP1150 Sound processor<br>* Active comparator off the ear sound processor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus) | Paired difference in dB SRT between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) (65 dB SPL (sound pressure level) S0Nrearhalf 4Talker Babble). | One day (in booth testing) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus) | Paired difference in dB SRT between the CP1170 SCAN 2 FF (ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF), (65 dB SPL S0N3 Babble). | One day (in booth testing) | 
| Speech perception in quiet with CP1170 and CP1150 Sound Processors | Paired difference in percentage CNC (consonant-nucleus-consonant) Words correct in quiet (50 dB) between the CP1170 sound processor and CP1150 sound processor (commercial version) | One day (in booth testing) | 
| Subjective acceptance and satisfaction between the CP1170 sound processor and the subject's own processor. | Ratings based on the CP1170 Questionnaire after a minimum 2-weeks actual-use of the CP1170 sound processor in the home environment and the subject's own processor. The CP1170 Questionnaire has a 5-point Likert scale for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = least favourable option to 3 = Neutral to 5 = most favourable option. | 2 weeks | 
| Subjective hearing performance between the CP1170 sound processor and the subject's own processor | Paired difference in Global SSQ12 scores after experience with the CP1170 sound processor and own processor. The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from baseline is then calculated and the theoretical score could vary between -10 to +10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing. | One day |