An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

Study Overview
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Brief Summary
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The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.

Official Title
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An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

Conditions
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Sensorineural Hearing Loss, Bilateral

Intervention / Treatment
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* Other: Clinical Education and Treatment Model
* Other: Traditional Model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes 18 years and older Postlingual onset of hearing loss (onset of hearing loss >two years of age) Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria Individuals who have recently been implanted but not yet had their external device activated Willingness to participate in a study and comply with all study requirements Fluent in spoken English Exclusion Criteria: Ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array Diagnosis of retro-cochlear pathology Diagnosis of auditory neuropathy Subject considering an acoustic component in the implanted ear Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device Unwillingness or inability to comply with all investigational requirements Severe-profound sensorineural hearing loss >30 years Previous cochlear implant in the contralateral ear. Additional cognitive, medical or social handicaps that would prevent completion of all study 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - New Model<br>Standardized programming and testing method | Other: Clinical Education and Treatment Model<br>* Patients will have self directed equipment education and standardized programming approaches<br>|
| Active Comparator: Group B - Traditional Model<br>Traditional clinical model which is not standardized across clinical sites | Other: Traditional Model<br>* Standard clinical practice and education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time Spent With Audiologist | Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B). | 6 months post activation |