CLEAR Clinical Study

Study Overview
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Brief Summary
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Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.

Official Title
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Clinical Evaluation of the SpatialNR Noise Reduction Algorithm

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: CP910/CP920 with noise reduction on
* Device: CP910/CP920


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18 years or older Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422) cochlear implant At least three months CI experience in ear to be assessed At least three months experience with the CP810,CP920 or CP910 sound processor Fluent speaker in the local language used to assess clinical performance Open-set speech perception ability Use of or eligibility for hybrid acoustic component (hybrid population only) Exclusion Criteria: Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device Unwillingness or inability of the candidate to comply with all investigational requirements Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study.

Ages Eligible for Study
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Minimum Age: 6 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional CI<br>The conventional CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order. | Device: CP910/CP920 with noise reduction on<br>* This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.<br>Device: CP910/CP920<br>* The approved CP910 or CP920 Sound Processor.<br>|
| Other: Hybrid CI<br>The Hybrid CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order. | Device: CP910/CP920 with noise reduction on<br>* This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.<br>Device: CP910/CP920<br>* The approved CP910 or CP920 Sound Processor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNC words | CNC words in quiet will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults. | 3 months | 
| SRT sentences | SRT sentences in noise will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults. | 3 months |