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| Name | Class |
|---|---|
| QbD Clinical | INDUSTRY |
| Avania | INDUSTRY |
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This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.
It aims to collect data to investigate if the new fitting method gives a good fit of MAP for newly implanted CI-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting. | Experimental | Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Categorical loudness scaling based fitting using the research fitting system. | Device | The research fitting system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate firmware updates of the system. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) | To determine whether the loudness target (LT) map provides non-inferior speech understanding in quiet compared to the behavioural map. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. The higher the score, the better the outcome. | At visit 4 (week 8) and visit 5 (week 12) |
| Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting) | To determine whether the loudness target (LT) map provides non-inferior speech understanding in noise compared to the behavioural map. Adaptive sentence in noise scores (S0N0 test setup) are averaged across the sessions at visit 4 and visit 5. Scores are expressed in decibels (dB). | At visit 4 (week 8) and visit 5 (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) | To determine whether the loudness target map provides non-inferior speech understanding, sound quality and spatial hearing performance subjective ratings in daily life compared to the behavioural map. The SSQ12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into 3 sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The average SSQ12 scores (on entire questionnaire) for each map type were used. SSQ12 ratings were collected at visit 4 and visit 5. The change between LT to behavioural map is then calculated and the theoretical score could vary between -10 to + 10. The higher the score, the better the benefit. A positive score indicates improved hearing, while a negative value indicates impaired hearing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anke Plasmans | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Americas | Lone Tree | Colorado | 80124 | United States | ||
| Cochlear Sydney |
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A counterbalanced cross-over design at visit 4 and 5 was used: while one group used first the behavioural fitting in daily life from week 4 to week 8 followed by the categorical loudness scaling based fitting from week 8 to week 12, the other group used each of these conditions in the opposite order.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioural Fitting Then Categorical Loudness Scaling Based Fitting | Participants will receive a categorical loudness scaling based fitting (interventional) and behavioural fitting with 4 weeks experience of both maps. Behavioural fitting using Custom Sound Suite (CSS 6.3) Software: The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software. Categorical loudness scaling based fitting using the research fitting system: The research fitting system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate Firmware updates of the system. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 24, 2025 |
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Participants are blinded to the order of fitting method. Some participants will use first the Behavioural program followed by the investigational program while the other group will use each of these conditions in the opposite order.
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| Behavioural fitting using Custom Sound Suite (CSS 6.3) Software | Device | The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software |
|
| At visit 4 (week 8) and visit 5 (week 12) |
| Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) | To determine whether the LT map provides non-inferior speech understanding in quiet compared to the behavioural map early post activation. | Visit 3 (week 4) |
| Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting) | To determine whether the LT map provides non-inferior speech understanding in noise compared to the behavioural map early post activation. Digit triplets are presented adaptively at different SNRs to estimate a patient's Speech Reception Threshold for 50%-digit triplet identification and expressed as a dB SNR (SNR50). The SRT is determined at the end of the test. A higher SRT means a worse outcome | Visit 3 (week 4) |
| Sydney |
| Sydney |
| 2113 |
| Australia |
| HEARnet | Carlton | Victoria | 3053 | Australia |
| Medizinische Hochschule Hannover (MHH) | Hanover | Hannover | 30625 | Germany |
| FG001 | Categorical Loudness Scaling Based Fitting Then Behavioural Fitting | Participants will receive a categorical loudness scaling based fitting (interventional) and behavioural fitting with 4 weeks experience of both maps. Behavioural fitting using Custom Sound Suite (CSS 6.3) Software: The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software. Categorical loudness scaling based fitting using the research fitting system: The research fitting system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate Firmware updates of the system. |
| COMPLETED |
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| NOT COMPLETED |
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All participants received both interventions. The order of fitting type (categorical loudness scaling based fitting or behavioural fitting) was counterbalanced to control for order effects. Baseline characteristics were reported for the overall study cohort rather than by sequence. Baseline characteristics stratified by sequence are not available.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants received both interventions: categorical loudness scaling based fitting and behavioural fitting. Categorical loudness scaling based fitting using the research fitting system: The research fitting system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate firmware updates of the system. Behavioural fitting using Custom Sound Suite (CSS 6.3) Software: The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software. |
| 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 | Standard Deviation | 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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| 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 | Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) | To determine whether the loudness target (LT) map provides non-inferior speech understanding in quiet compared to the behavioural map. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. The higher the score, the better the outcome. | Posted | Mean | Standard Deviation | percentage of words correct | At visit 4 (week 8) and visit 5 (week 12) |
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| Primary | Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting) | To determine whether the loudness target (LT) map provides non-inferior speech understanding in noise compared to the behavioural map. Adaptive sentence in noise scores (S0N0 test setup) are averaged across the sessions at visit 4 and visit 5. Scores are expressed in decibels (dB). | Posted | Mean | Standard Deviation | dB | At visit 4 (week 8) and visit 5 (week 12) |
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| Secondary | Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) | To determine whether the loudness target map provides non-inferior speech understanding, sound quality and spatial hearing performance subjective ratings in daily life compared to the behavioural map. The SSQ12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into 3 sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The average SSQ12 scores (on entire questionnaire) for each map type were used. SSQ12 ratings were collected at visit 4 and visit 5. The change between LT to behavioural map is then calculated and the theoretical score could vary between -10 to + 10. The higher the score, the better the benefit. A positive score indicates improved hearing, while a negative value indicates impaired hearing. | Posted | Mean | Standard Deviation | score on a scale | At visit 4 (week 8) and visit 5 (week 12) |
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| Secondary | Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) | To determine whether the LT map provides non-inferior speech understanding in quiet compared to the behavioural map early post activation. | Posted | Mean | Standard Deviation | percentage of words correct | Visit 3 (week 4) |
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| Secondary | Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting) | To determine whether the LT map provides non-inferior speech understanding in noise compared to the behavioural map early post activation. Digit triplets are presented adaptively at different SNRs to estimate a patient's Speech Reception Threshold for 50%-digit triplet identification and expressed as a dB SNR (SNR50). The SRT is determined at the end of the test. A higher SRT means a worse outcome | Posted | Mean | Standard Deviation | dB | Visit 3 (week 4) |
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12 weeks
Adverse events are reported for the overall study cohort rather than by intervention group. Separate adverse event data by fitting method were not prospectively collected, as both fitting methods were applied within the same cohort and safety monitoring was conducted at the participant level rather than per fitting method. Consequently, adverse events are presented in a combined manner to accurately reflect the available safety data.
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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 Study Participants | Participants will receive a categorical loudness scaling based fitting (interventional) and behavioural fitting with 4 weeks experience of both maps. Categorical loudness scaling based fitting using the research fitting system: The research fitting system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate Firmware updates of the system. Behavioural fitting using Custom Sound Suite (CSS 6.3) Software: The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software. | 0 | 17 | 0 | 17 | 7 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| knee collapse/buckle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Not related to device |
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| knee surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Not related to device |
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| air in the implant bed | Surgical and medical procedures | Non-systematic Assessment | Not related to device |
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| discomfort on head | General disorders | Non-systematic Assessment | Not related to device |
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| Dizziness | General disorders | Non-systematic Assessment | Not related to device |
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| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment | One event was not device-related; the other was possibly device-related |
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| Loudness discomfort | Ear and labyrinth disorders | Non-systematic Assessment | Definitely related to device |
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| unsteady on feet | General disorders | Non-systematic Assessment | Not related to device |
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| map uncomfortable for high pitch sounds | Ear and labyrinth disorders | Non-systematic Assessment | Definitely related to device |
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| tightness around implant area | General disorders | Non-systematic Assessment | Possibly related to device |
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| redness and sensitivity at magnet site. | Ear and labyrinth disorders | Non-systematic Assessment | Definitely related to device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | Cochlear Limited | +61294286555 | cltd-prs-admin@cochlear.com |
| Jan 14, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| 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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