Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Avania | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150. The study also investigates CP1110 and CP1150 with Forward Focus.
This study will build on the evidence previously collected on OTE and BTE Sound Processors and will support the design goals for access to the same sound processing algorithms across future OTE and BTE variants, including evidence required on the automation of FF and future implant compatibility.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Order 1 | Experimental | CP1150, then CP1150 NF, then CP1110, then CP1150 + FF |
|
| Test Order 2 | Experimental | CP1150 NF, then CP1150 + FF, then CP1150, then CP1110 |
|
| Test Order 3 | Experimental | CP1150 + FF, then CP1110, then CP1150 NF, then CP1150 |
|
| Test Order 4 | Experimental | CP1110, thenCP1150, then CP1150 + FF, then CP1150 NF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP1150 Sound Processor | Device | Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Perception in Quiet Using an CP1150 Sound Processor | Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware. | One day (in booth testing) |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality. | Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with forward focus | One day (in booth testing) |
| Speech Perception in Quiet With CP1150 and CP1110 Sound Processors |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Sydney | Macquarie Park | New South Wales | 2109 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants (CP1150 SP Compared With Next Generation Signal Processing Technology) | All study participants attended a single study visit. At the study visit, subjects underwent hearing assessments. Speech perception tests were carried out in all participants in a randomized manner with 4 interventions involving the CP1150 Sound Processor, CP1150 with modified firmware, CP1150 Sound Processor with Forward Focus and the CP1110 Sound Processor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants (CP1150 SP Compared With Next Generation Signal Processing Technology) | All study participants attended a single study visit. At the study visit, subjects underwent hearing assessments. Speech perception tests were carried out in all study participants in a randomized manner with 4 interventions involving the CP1150 Sound Processor, CP1150 with modified firmware, CP1150 Sound Processor with Forward Focus and the CP1110 Sound Processor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 in Quiet Using an CP1150 Sound Processor | Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware. | Posted | Mean | Standard Deviation | percentage of correct words | One day (in booth testing) |
|
|
1 day (in booth testing)
Speech perception tests were carried out in all study participants in a randomized manner with 4 interventions involving the CP1150 Sound Processor, CP1150 sound processor with modified firmware, CP1150 Sound Processor with Forward Focus and the CP1110 Sound Processor. All study participants attended a single study visit. At the study visit safety was assessed by recording and summarizing all adverse events and no adverse events were observed during the speech perception tests.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Orders 1, 2, 3 & 4 Combined | All subjects tested regardless of order of testing. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear Ltd. | +61294286555 | cltd-prs-admin@cochlear.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2022 | Jan 24, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2022 | Mar 2, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CP1150 NF | Device | Speech perception tests whilst the subject is fitted with the CP1150 modified firmware (the addition of notch filters at 978Hz, 1956Hz, 2934Hz, 3912Hz). |
|
| CP1150 + FF | Device | Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus. |
|
| CP1110 | Device | Speech perception tests whilst the subject is fitted with the CP1110 Sound Processor. |
|
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor |
| One day (in booth testing) |
| 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 |
|
| Age at hearing implant | Mean | Standard Deviation | years |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality. | Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with forward focus | Posted | Mean | Standard Deviation | percentage of correct words | One day (in booth testing) |
|
|
|
|
| Secondary | Speech Perception in Quiet With CP1150 and CP1110 Sound Processors | Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor | Posted | Mean | Standard Deviation | percentage of correct words | One day (in booth testing) |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
Not provided
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |