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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'.
The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'. This study will build on the evidence collected in previous Nucleus 7 Sound Processor take home studies and will also aim to confirm the in-booth performance of CP1110 and Nucleus 7 Sound Processors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP1110 with automated ForwardFocus On (SCAN 2 FF), CP1110 with ForwardFocus Off (SCAN 2), and CP1000 | Other | All participants assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000) in a random order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF) | Device | Sound Processor |
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| Measure | Description | Time Frame |
|---|---|---|
| Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf) | Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus ON (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0Nrearhalf 4TB. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3) | Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus On (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0N3 Babble. | 6 months |
| Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Sydney | Sydney | New South Wales | 2109 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41046328 | Derived | Nel E, Hong W, Playford J, Mashal ME. A clinical and real-world investigation of cochlear implant recipient speech performance in noise with the automation of ForwardFocus. Int J Audiol. 2025 Oct 4:1-9. doi: 10.1080/14992027.2025.2561889. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants were assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| CP1110 With ForwardFocus On (SCAN 2 FF) |
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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 | Aug 31, 2021 |
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Prospective, pre-market, single-site, non-randomized.
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| Nucleus 7 Sound Processor (model: CP1000) system | Device | Sound Processor |
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| CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) | Device | Sound Processor |
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Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound Processor and Nucleus 7 Sound Processor. |
| 6 months |
| Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor | Paired difference in Global Speech, Spatial and Qualities of Hearing Scale (SSQ12) scores after experience with the CP1110 Sound Processor and Nucleus 7 Sound Responses. SSQ12 have a minimum value of 0 and a maximum of 10, wherein a higher score means a better outcome. | Baseline (Nucleus 7) and Visit 2 (6 months, CP1110) |
| COMPLETED |
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| NOT COMPLETED |
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| CP1110 With ForwardFocus Off (SCAN 2) |
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| CP1000 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants were assigned to CP1110 Sound Processor System with ForwardFocus On (SCAN), CP1110 Sound Processor System with ForwardFocus Off (SCAN) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000) in a random order. |
| 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, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Age of onset of hearing loss | Mean | Standard Deviation | years |
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| 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 Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf) | Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus ON (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0Nrearhalf 4TB. | Posted | Mean | 95% Confidence Interval | dB SRT | 6 months |
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| Secondary | Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3) | Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus On (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0N3 Babble. | Posted | Mean | 95% Confidence Interval | dB SRT | 6 months |
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| Secondary | Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor | Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound Processor and Nucleus 7 Sound Processor. | Posted | Mean | 95% Confidence Interval | percentage of correct words | 6 months |
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| Secondary | Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor | Paired difference in Global Speech, Spatial and Qualities of Hearing Scale (SSQ12) scores after experience with the CP1110 Sound Processor and Nucleus 7 Sound Responses. SSQ12 have a minimum value of 0 and a maximum of 10, wherein a higher score means a better outcome. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Nucleus 7) and Visit 2 (6 months, CP1110) |
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6 months
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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 | All 20 participants were assigned to investigate the acceptance and performance of a new behind-the-ear sound processor (Model: CP1110) with the ForwardFocus feature turned on and off, as compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000). | 0 | 20 | 0 | 20 | 13 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Investigations | Non-systematic Assessment | Headache from CP1110 magnet being too strong. |
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| Bodyache | General disorders | Non-systematic Assessment |
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| Common cold | General disorders | Non-systematic Assessment |
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| Cough | General disorders | Non-systematic Assessment |
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| High fever | General disorders | Non-systematic Assessment |
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| Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| One sided headache and neck pain | General disorders | Non-systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Skin lump | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Trigger finger | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Urine retention | Renal and urinary disorders | Non-systematic Assessment |
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| Viral infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear Ltd. | +61 2 9428 6555 | cltd-prs-admin@cochlear.com |
| Jan 24, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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