Clinical Evaluation of a Cochlear Implant Sound Processor

Study Overview
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Brief Summary
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This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit

Detailed Description
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The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.

Official Title
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Evaluation of AutoSense OS on a Cochlear Implant Sound Processor Programmed With Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System

Conditions
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Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases

Intervention / Treatment
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* Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software
* Device: 301-M062 sound processor & software


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: Ability to provide Informed Consent 18 years of age or older Unilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D), including bilaterally implanted subjects that only use one implant in their everyday listening modality Minimum of 6 months of CI experience Having used a Naída CI Q70 or a Naída CI Q90 as their primary processor for a minimum of one month Presently using a current steering strategy At least moderate open-set speech recognition abilities with implant alone, as defined by achieving a score of ≥ 60% words correct in the AzBio in quiet test using the Naída CI Q90 research processor English language proficiency as determined by the investigator Willingness to use a BTE processor for the duration of the study ARH Arm Inclusion Criteria Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear Willingness to use an in-canal acoustic earhook for the duration of the study EO Arm Inclusion Criteria • Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125, 250, and 500 Hz) and high frequencies (pure tone average ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear Exclusion Criteria: Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aidable Residual Hearing (ARH) Cohort<br>Control Device followed by experimental Device. | Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software<br>* Control cochlear implant sound processor<br>Device: 301-M062 sound processor & software<br>* New cochlear implant sound processor<br>|
| Other: Electric Only (EO) Cohort<br>Control Device followed by experimental Device. | Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software<br>* Control cochlear implant sound processor<br>Device: 301-M062 sound processor & software<br>* New cochlear implant sound processor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Recognition in Quiet | The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Recognition in Noise | Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | 1 Day | 
| Increased Speech Recognition in Noise | Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing Omnidirectional program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | 1 Day |