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Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Bilaterally Implanted with HiRes 90K device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HiRes 90K Bionic Ear System | Device | Cochlear implant system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. | Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported. | 8 months of bilateral cochlear implant use |
| Measure | Description | Time Frame |
|---|---|---|
| HINT Sentences in Noise | 20 sentences presented in noise at fixed levels | 8 months of bilateral cochlear implant use |
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Inclusion Criteria:
Exclusion Criteria:
No exclusion criteria specified, except for the opposite of inclusion criteria listed above.
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| Name | Affiliation | Role |
|---|---|---|
| Mary Joe Osberger | Advanced Bionics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| House Clinic/House Ear Institute | Los Angeles | California | 90057 | United States | ||
| California Ear Institute (Let Them Hear Foundation) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilaterally Implanted | 31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilaterally Implanted | 31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted. |
| 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 | Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. | Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported. | Adults with severe-to-profound hearing loss who received bilateral cochlear implants in the same operation. | Posted | Mean | Standard Deviation | percent of words correct | 8 months of bilateral cochlear implant use |
|
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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 | Bilaterally Implanted | 31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Ripley | Advanced Bionics, LLC | (661) 362-4572 | Kenneth.Ripley@advancedbionics.com |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Palo Alto |
| California |
| 94303 |
| United States |
| University of Miami - Cochlear Implant Center | Miami | Florida | 33136 | United States |
| Tampa Bay Hearing and Balance Center | Tampa | Florida | 33606 | United States |
| Carle Clinic Association | Urbana | Illinois | 61801 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49546 | United States |
| Midwest Ear Institute | Kansas City | Missouri | 64108 | United States |
| New York University Cochlear Implant Center | New York | New York | 10016 | United States |
| Dallas Otolaryngology Associates | Dallas | Texas | 75230 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Testing conducted with bilateral implants.
|
|
| Secondary | HINT Sentences in Noise | 20 sentences presented in noise at fixed levels | Not Posted | 8 months of bilateral cochlear implant use |
| 0 |
| 31 |
| 7 |
| 31 |
Investigators were not permitted to disclose study results until the Sponsor had completed data analyses and report generation for regulatory purposes, and/or received regulatory approval. The Sponsor agreed to notify the Investigators when they were free to publish, present or use any results arising out of this study for their own instructional, research, or publication objectives, provided that such publication did not disclose any of the Sponsor's proprietary information.
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |