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The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CI632 Slim Modiolar Electrode | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CI632 Slim Modiolar Electrode | Device | Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Characterize Hearing Performance of the CI632 in an Adult Population Under Expanded Indications for Use. | To characterize hearing performance of the CI632 using CNC word recognition in quiet (unilateral) scores with percentage correct words. | 14 months (12 months postactivation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States | ||
| Midwest Ear Institute |
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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| ID | Title | Description |
|---|---|---|
| FG000 | CI632 Slim Modiolar Electrode | The Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | The Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | To Characterize Hearing Performance of the CI632 in an Adult Population Under Expanded Indications for Use. | To characterize hearing performance of the CI632 using CNC word recognition in quiet (unilateral) scores with percentage correct words. | Posted | Mean | Standard Deviation | Percentage of words correct | 14 months (12 months postactivation) |
|
|
12 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 | All Participants | The Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure/ hypertension | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | Cochlear Limited | +61 2 9428 6555 | cltd-prs-admin@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2022 | May 27, 2026 | Prot_SAP_000.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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| Kansas City |
| Missouri |
| 64111 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44106 | United States |
| University Hospitals | Cleveland | Ohio | 44106 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 7 |
| 10 |
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Balance problems | Nervous system disorders | Non-systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Taste disorder | Nervous system disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Numbness | Nervous system disorders | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Aural fullness | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |