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The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control first, then Experimental (Group A) | Experimental | Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week. |
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| Experimental first, then Control (Group B) | Experimental | Initial subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control first, then Experimental | Device | Control condition is currently marketed sound processing strategy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis. | 2 weeks |
| Device-related Adverse Events | Device-related adverse events will be assessed to determine whether they impact current device safety performance. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
• Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| House Ear Clinic | Los Angeles | California | 90057 | United States | ||
| Tampa Bay Hearing and Balance |
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Investigators recruited study subjects from their clinic practice. Subjects were randomized to either Group A or Group B at the time of the baseline visit. First patient first visit occurred on May 25, 2012 and last patient last visit occurred on September 07, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control First, Then Experimental (Group A) | Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week. Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy. Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Experimental first, then Control | Device | Experimental condition is newly modified sound processing strategy. |
|
| Tampa |
| Florida |
| 33606 |
| United States |
| Carle Clinic Association | Urbana | Illinois | 61801 | United States |
| Midwest Ear Institute (MEI) | Kansas City | Missouri | 64111 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| FG001 | Experimental First, Then Control (Group B) | Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week. Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy. Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control First, Then Experimental (Group A) | Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week. Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy. Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System. |
| BG001 | Experimental First, Then Control (Group B) | Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week. Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy. Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. | Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis. | Posted | Mean | Standard Deviation | Percent Correct | 2 weeks |
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| Primary | Device-related Adverse Events | Device-related adverse events will be assessed to determine whether they impact current device safety performance. | Posted | Number | Events | 2 weeks |
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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 | Control First, Then Experimental (Group A) | Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System condition for the second week. Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy. Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System. | 0 | 18 | 2 | 18 | ||
| EG001 | Experimental First, Then Control (Group B) | Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week. Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy. Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System. | 0 | 18 | 3 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Cold | General disorders | Systematic Assessment |
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PI agrees to submit any publication to Sponsor (S) at least 30 days prior to submission. Within 30 days of its receipt, S advises PI in writing of any information contained therein which is Confidential Information (CI) (other than Study Data) or which may impair the availability of patent protection for Inventions. S has the right to require PI to remove specifically identified CI and/or to delay the publication for an additional 60 days to enable S to seek patent protection for Inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cedric Navarro, Vice President of Regulatory/Clinical Affairs and Quality | Advanced Bionics, LLC | (661) 362-1963 | Clinical.Research@advancedbionics.com |
| >=65 years |
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| Male |
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| MTB |
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| Participants |
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