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This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | Other | Recipients of cochlear implant or suitable for implantation Interrupted time series: recipients received standard and novel fitting method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique | Device | The investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet | The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method | 0 to 4 weeks after fitting |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HEARnet Clinical Studies - The University of Melbourne | Carlton | Victoria | 3052 | Australia | ||
| Cochlear Ltd. Melbourne |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Cohort | Recipients of cochlear implant or suitable for implantation Recipients received standard and novel fitting methods during the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Cohort | Recipients of cochlear implant or suitable for implantation Recipients received standard and novel fitting methods during the study |
| 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 | Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet | The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method | All study recipients received the standard and novel fitting methods at different timepoints of the study. | Posted | Mean | 95% Confidence Interval | difference in percentage correct answers | 0 to 4 weeks after fitting |
|
|
3 weeks
Subjects were monitored over the study duration which was approximately 3 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 | Study Cohort | Recipients of cochlear implant or suitable for implantation | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | Cochlear | +61294286555 | cltd-prs-admin@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2022 | Feb 26, 2025 | Prot_SAP_001.pdf |
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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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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| D003933 | Diagnosis |
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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Interrupted time series
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Participants were masked to which fitting method they had at any point in the study
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|
| East Melbourne |
| Victoria |
| 3002 |
| Australia |
| AZ Sint-Jan Brugge-Oostende AV | Bruges | Belgiƫ | 8000 | Belgium |
| Sint-Augustinus Antwerpen | Wilrijk | Belgiƫ | 2610 | Belgium |
| Cochlear Technology Centre Belgium | Mechelen | 2800 | Belgium |
| 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 |
|
| Average period of CI experience | Mean | Full Range | years |
|
| Device type | Count of Participants | Participants |
|
| Participants |
|
|
| 20 |
| 0 |
| 20 |
| 5 |
| 20 |
| Discomfort | General disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |
| D008919 | Investigative Techniques |