ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users

Study Overview
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Brief Summary
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The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations.

Official Title
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Evaluation of the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing

Conditions
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Implant

Intervention / Treatment
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* Device: ClearVoice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-lingually deafened, experienced (6 months device use), adult users of the Harmony HiResolution Bionic Ear System and HiRes Fidelity 120 sound processing. English language proficiency

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: ClearVoice Medium<br>Chronic use of ClearVoice MEDIUM for two weeks followed by chronic use of ClearVoice HIGH for two weeks. | Device: ClearVoice<br>* ClearVoice is a sound processing strategy designed to improve listening ability in some challenging everyday listening environments for users of the Harmony® HiResolution® Bionic Ear System (Harmony®)<br>|
| Experimental: Group B: ClearVoice High<br>Chronic use of ClearVoice HIGH for two weeks followed by chronic use of ClearVoice MEDIUM for two weeks. | Device: ClearVoice<br>* ClearVoice is a sound processing strategy designed to improve listening ability in some challenging everyday listening environments for users of the Harmony® HiResolution® Bionic Ear System (Harmony®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise | This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis. | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble. |  | 2-4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implant, adults, HiResolution, Fidelity 120, listening benefits, noise, cochlear implant benefit