Back to resultsAn Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
Primary Purpose
Sensorineural Hearing Loss, Bilateral
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Education and Treatment Model
Traditional Model
Sponsored by
About this trial
This is an interventional other trial for Sensorineural Hearing Loss, Bilateral
Eligibility Criteria
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
Sites / Locations
- Head and Neck Surgical Associates
- Puget Sound ENT
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A - New Model
Group B - Traditional Model
Arm Description
Standardized programming and testing method
Traditional clinical model which is not standardized across clinical sites
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03904420
Brief Title
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
Official Title
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
FDA determination of Fox software as class III medical device, not CDSS.
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
October 29, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Bilateral
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A - New Model
Arm Type
Experimental
Arm Description
Standardized programming and testing method
Arm Title
Group B - Traditional Model
Arm Type
Active Comparator
Arm Description
Traditional clinical model which is not standardized across clinical sites
Intervention Type
Other
Intervention Name(s)
Clinical Education and Treatment Model
Intervention Description
Patients will have self directed equipment education and standardized programming approaches
Intervention Type
Other
Intervention Name(s)
Traditional Model
Intervention Description
Standard clinical practice and education
Primary Outcome Measure Information:
Title
Change in Time Spent With Audiologist
Description
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).
Time Frame
6 months post activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Head and Neck Surgical Associates
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Puget Sound ENT
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
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