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| Name | Class |
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| Avania | INDUSTRY |
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This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
Performance of four programs (MAPs), each with a different rate, PW and stimulation mode were evaluated, all using 8 maxima: (i) 900 Hz rate, 25 µs PW Default (ii) 900 Hz rate, 50 µs PW LP1, (iii) 500 Hz rate, 100 µs PW LP2 all using Monopolar stimulation mode, and (iv) 500 Hz rate, 100 µs PW using an investigational stimulation mode LP3
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors | Experimental | Participants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Program using default MAP | Device | Each MAP uses a specific combination of stimulation parameters and electrode mode. |
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| Measure | Description | Time Frame |
|---|---|---|
| Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet | Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints. | 10 participants completed this test at Week 4, and 10 participants completed this at week 8 |
| Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise | Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints. | 10 participants completed the test at Week 4, 10 participants completed the test at Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet | Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each MAP. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esti Nel | Cochlear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Macquarie | Macquarie Park | New South Wales | 2109 | Australia |
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants evaluated each test of the 4 test programs:
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| Title | Milestones | Reasons Not Completed | |||||
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| Default MAP |
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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 | Feb 5, 2024 |
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There is no masking in this study as all participants receive all MAPs (single group study model). The term "single-blinded" in the official title refers to the fact that participants are blinded to the order in which they receive the MAPs.
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| Program using low-power 1 (LP1) MAP | Device | Each MAP uses a specific combination of stimulation parameters and electrode mode. |
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| Program using low-power 2 (LP2) MAP | Device | Each MAP uses a specific combination of stimulation parameters and electrode mode. |
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| Program using low-power 3 (LP3) MAP | Device | Each MAP uses a specific combination of stimulation parameters and electrode mode. |
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| 10 participants completed the test at Week 4, 10 participants completed the test at Week 8 |
| Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise | Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints. | 10 participants completed this test at Week 4, and 10 participants completed this at week 8 |
| Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet | Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints. | 10 participants completed this test at Week 4, and 10 participants completed this at week 8 |
| Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise | Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints. | 10 participants completed this test with at Week 4 and 10 participants completed this at week 8 |
| Switching Acceptability Rating Between LP2 and LP3 MAPs | Participants rated the sound quality when switching between the LP2 and LP3 MAPs with the investigator asking the question: How does the sound quality of the new program compare with the previous program in terms of sound quality? The possible responses being "very different, somewhat different, similar, or the same". The number of participants in each category will be reported. | 10 participants were evaluated at week 4 and 10 participants were evaluated at week 8 |
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| NOT COMPLETED |
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| Low Power 1 (LP1) MAP |
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| Low Power 2 (LP2) MAP |
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| Low Power 3 (LP3) MAP |
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All participants were assigned to be tested with each test MAP (LP1, LP2, LP3) and the baseline (Default).
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants used four different MAPs (Default, LP1, LP2 and LP3) during two take-home periods, completing hearing assessments and questionnaires The study sound processor was Cochlear™ Nucleus® 7, Nucleus® 8 or Kanso® 2 sound processors depending on the participants usual Sound Processor type. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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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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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet | Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints. | One participant had the default MAP created using a Pulse Width of 37 µs rather than the required 25 µs, so there were 19 paired data points for analysis. All remaining participants were tested with the Default and LP1 MAPs | Posted | Mean | 95% Confidence Interval | percentage word score | 10 participants completed this test at Week 4, and 10 participants completed this at week 8 |
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| Primary | Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise | Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints. | One participant had the default MAP created using a Pulse Width of 37 µs rather than the required 25 µs, so there were 19 paired data points for analysis. All remaining participants were tested with the Default and LP1 MAPs | Posted | Mean | 95% Confidence Interval | dB SRT | 10 participants completed the test at Week 4, 10 participants completed the test at Week 8 |
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| Secondary | Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet | Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each MAP. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints. | All participants were tested with the LP1 and LP2 MAPs | Posted | Mean | 95% Confidence Interval | percentage word score | 10 participants completed the test at Week 4, 10 participants completed the test at Week 8 |
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| Secondary | Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise | Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints. | All participants were tested with the LP1 and LP2 MAPs | Posted | Median | 95% Confidence Interval | dB SRT | 10 participants completed this test at Week 4, and 10 participants completed this at week 8 |
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| Secondary | Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet | Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints. | All participants were tested with the LP1 and LP3 MAPs | Posted | Mean | 95% Confidence Interval | percentage word score | 10 participants completed this test at Week 4, and 10 participants completed this at week 8 |
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| Secondary | Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise | Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints. | All participants were tested with the LP1 and LP3 MAPs. | Posted | Mean | 95% Confidence Interval | dB SRT | 10 participants completed this test with at Week 4 and 10 participants completed this at week 8 |
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| Secondary | Switching Acceptability Rating Between LP2 and LP3 MAPs | Participants rated the sound quality when switching between the LP2 and LP3 MAPs with the investigator asking the question: How does the sound quality of the new program compare with the previous program in terms of sound quality? The possible responses being "very different, somewhat different, similar, or the same". The number of participants in each category will be reported. | All participants evaluated switching between the LP2 and LP3 MAPs. | Posted | Count of Participants | Participants | 10 participants were evaluated at week 4 and 10 participants were evaluated at week 8 |
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Each participant was assessed from enrollment to final study visit, approximately 8 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) |
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| EG000 | All Participants | All participants who were tested with each MAP and completed the study. | 0 | 20 | 0 | 20 | 1 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Viral infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | Cochlear Limited | +61 2 9428 6555 | cltd-prs-admin@cochlear.com |
| Dec 15, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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