Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

Study Overview
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Brief Summary
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Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.

Official Title
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Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

Conditions
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Sensorineural Hearing Loss, Bilateral, Cochlear Implant

Intervention / Treatment
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* Device: Commercially available cochlear implant and AI system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly implanted and existing recipient Groups (Groups 1 and 2): Age 12 and older Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care Group 2: 3 months or greater combined experience with commercially available sound processors Fluent spoken English skills Exclusion Criteria: Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team Unwillingness or inability of the subject to comply with all investigational requirements Use of an acoustic component in the implanted ear Less than 18 active electrodes Hybrid L Cochlear Implant

Ages Eligible for Study
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Minimum Age: 12 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 |
| --- | --- |
| Experimental: Newly Implanted CI Recipients<br>Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients | Device: Commercially available cochlear implant and AI system<br>* Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients<br>|
| Experimental: Existing CI recipients<br>Use of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients | Device: Commercially available cochlear implant and AI system<br>* Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Monosyllabic Word Recognition Scores (CNC) in Quiet | Monosyllabic word recognition was scored in quiet using Consonant-Nucleus-Consonant (CNC) words. Scores are listed as percentage correct thus a higher score (percentage) means a better outcome.Group 1: Preoperative to postoperative percentage performance after 6 months of cochlear implant use. Group 2: Visit A to Visit B after 1 month of cochlear implant use. | Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month |