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Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear and at least 3 months experience with the CP810,CP920 or CP910 sound processor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP950 OTE Sound processor | Device | CP950 is Off The Ear (OTE) Cochlear Implant Sound Processor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score. | Each subject used the Investigational device (CP950) for take home use to obtain subjective ratings. During the take home use, A subjective questionnaire was asked them to recall and rate how their hearing performance with the Investigational device CP950 OTE processor compared to their hearing performance with their own CP810, CP910 or CP920 BTE processor. Likert scale was used for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = much worse; 2 = somewhat worse; 3 = No difference; 4 = somewhat better; 5 = much better. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor . | Signal to noise ratio (measured in decibels) providing 50% speech intelligibility for sentences presented in noise to evaluate the benefit from microphone directionality with the CP950 OTE (Off the ear) sound processor. | in booth testing 1 day. |
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Inclusion Criteria:
Exclusion Criteria:
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Protocol stated "up to 25" number of participants. 23 were enrolled, with 3 electing to withdraw from the study before completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear and at least 3 months experience with the CP810,CP920 or CP910 sound processor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Take Home Use of CP950 |
| |||||||||||||
| First In Booth Testing of CP950 |
| |||||||||||||
| Second Take Home Use of CP950 |
| |||||||||||||
| Second In Booth Testing of CP950 |
|
All Study Participants
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants enrolled in the study |
| 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 | Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score. | Each subject used the Investigational device (CP950) for take home use to obtain subjective ratings. During the take home use, A subjective questionnaire was asked them to recall and rate how their hearing performance with the Investigational device CP950 OTE processor compared to their hearing performance with their own CP810, CP910 or CP920 BTE processor. Likert scale was used for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = much worse; 2 = somewhat worse; 3 = No difference; 4 = somewhat better; 5 = much better. | Posted | Mean | Inter-Quartile Range | Units on a likert scale | 14 days |
|
11 months
Adverse events were collected during the periods when participants were using the investigational device (CP950).
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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 | At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear and at least 3 months experience with the CP810, CP920 or CP910 sound processor. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort Headache and pain | Investigations | Non-systematic Assessment | Discomfort/pain/headache at the site of the processor magnet. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marian Jones, Principal Investigator | Cochlear Ltd | +61498008181 | mjones@cochlear.com |
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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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Repeated measures, single-subject experiment. Each subject received the same treatment.
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| Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor |
Two lists of twenty sentences presented from front speaker with 4 Talker babble noise presented from rear-half speakers. Higher the percentage of correct words means better outcome. |
| In booth testing 1 day |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| 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 |
|
|
|
| Secondary | Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor . | Signal to noise ratio (measured in decibels) providing 50% speech intelligibility for sentences presented in noise to evaluate the benefit from microphone directionality with the CP950 OTE (Off the ear) sound processor. | Posted | Mean | Standard Error | decibles | in booth testing 1 day. |
|
|
|
| Secondary | Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor | Two lists of twenty sentences presented from front speaker with 4 Talker babble noise presented from rear-half speakers. Higher the percentage of correct words means better outcome. | Posted | Mean | Standard Deviation | percentage of correct words. | In booth testing 1 day |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 19 |
| 20 |
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| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Loud Crackling sound | Ear and labyrinth disorders | Non-systematic Assessment |
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| Vertigo and pre planned hospitalization | General disorders | Non-systematic Assessment |
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| Ear infection | Infections and infestations | Non-systematic Assessment |
|
| Fall at car park | Social circumstances | Non-systematic Assessment |
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| Pain at the site of processor magnet | Investigations | Non-systematic Assessment |
|
| Pleurisy | Infections and infestations | 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 |