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| Name | Class |
|---|---|
| University of Iowa | OTHER |
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Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.
The Food and Drug Administration recently approved the Cochlear Nucleus Hybrid L24 Implant System (P130016) for individuals aged 18 years and older who present with bilateral residual low frequency hearing sensitivity and severe to profound high frequency sensorineural hearing loss with limited benefit from appropriately fitted bilateral amplification. Additionally, the Nucleus Hybrid S12 Implant has been under evaluation since 2007 (IDE G#070016). The Nucleus Hybrid S-RW is a modification of the current Hybrid S12 implant. The Hybrid S-RW is designed to support implantation via a round window (RW) approach while maintaining the same relative insertion depth as the previous Hybrid S12 when implanted via cochleostomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted | Experimental | Subjects will be implanted with the Hybrid SRW cochlear implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid SRW cochlear implant | Device | Subjects will be implanted with the Hybrid SRW |
|
| Measure | Description | Time Frame |
|---|---|---|
| CNC (Consonant-nucleus-consonant) Words | Two CNC( consonant-nucleus-consonant) Word lists (Peterson & Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Des Moines | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15035561 | Background | Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014. | |
| 23651462 | Background | Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: the SSQ12. Int J Audiol. 2013 Jun;52(6):409-12. doi: 10.3109/14992027.2013.781278. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Implanted | Subjects will be implanted with the Hybrid SRW cochlear implant. Hybrid SRW cochlear implant: Subjects will be implanted with the Hybrid SRW |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implanted | Subjects will be implanted with the Hybrid SRW cochlear implant. Hybrid SRW cochlear implant: Subjects will be implanted with the Hybrid SRW |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | CNC (Consonant-nucleus-consonant) Words | Two CNC( consonant-nucleus-consonant) Word lists (Peterson & Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome. | Only 5 subjects were analysed rather than 6 as one subject used electric mode only by 12 months post activation. | Posted | Mean | Standard Deviation | percentage of correct words. | 12 months |
|
1 year
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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 will be implanted with the Hybrid SRW cochlear implant. Hybrid SRW cochlear implant: Subjects will be implanted with the Hybrid SRW |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden hearing threshold shift resulting in profound hearing loss | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear Limited | +612 9428 6555 | cltd-prs-admin@cochlear.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2018 | Aug 10, 2022 | Prot_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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| 14485785 | Background | PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available. |
| 21829134 | Background | Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549. |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Age at Implant in Years | Mean | Standard Deviation | years |
|
| Duration of Hearing Loss | Mean | Standard Deviation | years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 4 |
| 6 |
| Significant decrease in hearing thresholds (20-35dB) | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Skin Flap soreness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subject noticing some soreness at the magnet. Magnet strength was reduced from a 2 to 1. Still tender. Instructed patient to discontinue use until sore is fully healed |
|
| Open circuit electrodes | Product Issues | Non-systematic Assessment | Resolved by deactivating the electrode. |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Increased tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| external otitis | 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 |