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The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: ClearVoice Medium | Experimental | Chronic use of ClearVoice MEDIUM for two weeks followed by chronic use of ClearVoice HIGH for two weeks. |
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| Group B: ClearVoice High | Experimental | Chronic use of ClearVoice HIGH for two weeks followed by chronic use of ClearVoice MEDIUM for two weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearVoice | Device | ClearVoice is a sound processing strategy designed to improve listening ability in some challenging everyday listening environments for users of the Harmony® HiResolution® Bionic Ear System (Harmony®) |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise | This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis. | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble. | 2-4 weeks |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| House Ear Clinic | Los Angeles | California | 90057 | United States | ||
| Carle Clinic Association |
All subjects were fit acutely at the Baseline Visit (Visit 1) with ClearVoice Low and underwent acute speech perception testing. Each subject was then randomized to Group A or Group B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Received ClearVoice MEDIUM Followed by HIGH | Two weeks of chronic use of ClearVoice MEDIUM followed by two week of chronic use of ClearVoice HIGH. |
| FG001 | Group B: Received ClearVoice HIGH Followed by MEDIUM | Two week of chronic use of Clearvoice HIGH followed by two week of chronic use of ClearVoice MEDIUM. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ClearVoice |
| 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 |
| 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 of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise | This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis. | Posted | Mean | Standard Deviation | percentage of words scored correctly | 4 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 | Group 1 | Primary efficacy analyses were based on data from the 46 subjects that completed the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Ripley, Director of Clinical Research | Advanced Bionics, LLC | 1.661.362.1400 | clinical.research@advancedbionics.com |
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| Urbana |
| Illinois |
| 61801 |
| United States |
| University of Kentucky | Lexington | Kentucky | 40506-9983 | United States |
| The Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Midwest Ear Institute | Kansas City | Missouri | 64111 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Nova Scotia Hearing and Speech Centres | Halifax | Nova Scotia | B3J 3R4 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | M4N 3M5 | Canada |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble. | Not Posted | 2-4 weeks | Participants |
| 0 |
| 46 |
| 0 |
| 46 |
At least 60 days before submission for publication, presentation or use, Institution or Principal Investigator will submit to Sponsor for review and comment any proposed oral or written Publication. Sponsor will have the right to request any modification of any Publication if in Sponsor's reasonable opinion that Publication would jeopardize a patent application or patent.