Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear

Study Overview
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Brief Summary
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The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.

Conditions
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Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System

Intervention / Treatment
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* Device: Control first, then Experimental
* Device: Experimental first, then Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy 18 years of age or older at time of implant Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age) At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users) English language proficiency Willingness to use a Harmony™ BTE processor and refrain from ClearVoice™ use for the duration of the study Willingness and ability to participate in all scheduled procedures outlined in the protocol Exclusion Criteria: • Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing

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: Control first, then Experimental (Group A)<br>Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week. | Device: Control first, then Experimental<br>* Control condition is currently marketed sound processing strategy.<br>|
| Experimental: Experimental first, then Control (Group B)<br>Initial subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week. | Device: Experimental first, then Control<br>* Experimental condition is newly modified sound processing strategy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis. | 2 weeks | 
| Device-related Adverse Events | Device-related adverse events will be assessed to determine whether they impact current device safety performance. | 2 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