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To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted | Experimental | Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Nucleus CI532 | Device | cochlear implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear | Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet. | 3 months postactivation of the sound processor |
| Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear | unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise | 3 months post-activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University | Skokie | Illinois | 60201 | United States | ||
| University of Iowa |
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| ID | Title | Description |
|---|---|---|
| FG000 | Implanted | Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Cochlear Nucleus CI532: cochlear implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implanted | Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Cochlear Nucleus CI532: cochlear implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear | Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet. | implanted and enrolled | Posted | Mean | Standard Deviation | percent correct | 3 months postactivation of the sound processor |
|
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implanted | Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Cochlear Nucleus CI532: cochlear implantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Systematic Assessment | death from recurrence of a previous medical condition unrelated to the device or procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial nerve | Ear and labyrinth disorders | Systematic Assessment | Facial nerve weakness following surgery, Treated with oral medications and resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ginger Grant, AuD | Cochlear Americas | 410-375-0883 | ggrant@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2016 | Dec 13, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2018 | Jan 23, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Iowa City |
| Iowa |
| 52242 |
| United States |
| The University of Michigan | Ann Arbor | Michigan | 48108 | United States |
| Center for Hearing and Balance | Chesterfield | Missouri | 63017 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| Dallas Ear Institute | Dallas | Texas | 75230 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Speech understanding (% correct) on AzBio sentences in quiet in the ear to be implanted | Mean | Standard Deviation | percent correct |
|
| Speech understanding (% correct) on AzBio sentences in noise in the ear to be implanted | Mean | Standard Deviation | percent correct |
|
| Participants |
|
|
| Primary | Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear | unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise | implanted and enrolled | Posted | Mean | Standard Deviation | percent correct | 3 months post-activation |
|
|
|
| 1 |
| 24 |
| 2 |
| 24 |
| 6 |
| 24 |
|
| skin flap | Infections and infestations | Systematic Assessment | Incision breakdown, revised successfully in the OR |
|
|
| Vertigo or dizziness | Ear and labyrinth disorders | Systematic Assessment | with stimulation of specific electrodes |
|
| Tingling sensation | Ear and labyrinth disorders | Systematic Assessment | tingling/shocking with stimulation of specific electrodes. Programmed around, resolved |
|
| Device related/programming problems | Product Issues | Systematic Assessment | open circuit |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |