Trial Outcomes & Findings for Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation (NCT NCT05709223)
NCT ID: NCT05709223
Last Updated: 2026-05-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
At visit 4 (week 8) and visit 5 (week 12)
Results posted on
2026-05-15
Participant Flow
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.
Participant milestones
| Measure |
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.
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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.
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Overall Study
STARTED
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9
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8
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Overall Study
COMPLETED
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7
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6
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Overall Study
NOT COMPLETED
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2
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=17 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.
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Age, Continuous
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62.4 years
STANDARD_DEVIATION 17.9 • n=17 Participants
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Sex: Female, Male
Female
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7 Participants
n=17 Participants
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Sex: Female, Male
Male
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10 Participants
n=17 Participants
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PRIMARY outcome
Timeframe: At visit 4 (week 8) and visit 5 (week 12)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.
Outcome measures
| Measure |
All Study Participants
n=14 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.
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Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Behavioural fitting
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35.64 percentage of words correct
Standard Deviation 15.71
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Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Categorical loudness scaling based fitting
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37.15 percentage of words correct
Standard Deviation 16.21
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Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Behavioural fitting minus categorical loudness scaling based fitting
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-1.52 percentage of words correct
Standard Deviation 7.53
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PRIMARY outcome
Timeframe: At visit 4 (week 8) and visit 5 (week 12)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).
Outcome measures
| Measure |
All Study Participants
n=13 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.
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Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting)
Behavioural fitting
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5.73 dB
Standard Deviation 2.55
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Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting)
Categorical Loudness Scaling Based Fitting
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6.02 dB
Standard Deviation 2.93
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Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting)
Categorical loudness scaling based fitting minus behavioural fitting
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0.29 dB
Standard Deviation 1.45
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SECONDARY outcome
Timeframe: At visit 4 (week 8) and visit 5 (week 12)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.
Outcome measures
| Measure |
All Study Participants
n=12 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.
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Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Behavioural fitting
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5.41 score on a scale
Standard Deviation 1.92
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Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Categorical loudness scaling based fitting
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5.32 score on a scale
Standard Deviation 2.23
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Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Behavioural fitting minus categorical loudness scaling based fitting
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0.09 score on a scale
Standard Deviation 0.87
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SECONDARY outcome
Timeframe: Visit 3 (week 4)To determine whether the LT map provides non-inferior speech understanding in quiet compared to the behavioural map early post activation.
Outcome measures
| Measure |
All Study Participants
n=15 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.
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Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Behavioural fitting
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42.78 percentage of words correct
Standard Deviation 20.92
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Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Categorical loudness scaling based fitting
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39.22 percentage of words correct
Standard Deviation 22.63
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Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
Behavioural fitting minus categorical loudness scaling based fitting
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3.56 percentage of words correct
Standard Deviation 10.01
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SECONDARY outcome
Timeframe: Visit 3 (week 4)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
Outcome measures
| Measure |
All Study Participants
n=15 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.
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Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting)
Behavioural fitting
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-3.94 dB
Standard Deviation 2.31
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Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting)
Categorical loudness scaling based fitting
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-3.95 dB
Standard Deviation 3.67
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Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting)
Categorical loudness scaling based fitting minus behavioural fitting
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-0.0006 dB
Standard Deviation 1.78
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Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Study Participants
n=17 participants at risk
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.
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Musculoskeletal and connective tissue disorders
knee collapse/buckle
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5.9%
1/17 • 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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Musculoskeletal and connective tissue disorders
knee surgery
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5.9%
1/17 • 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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Surgical and medical procedures
air in the implant bed
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5.9%
1/17 • 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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General disorders
discomfort on head
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5.9%
1/17 • 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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General disorders
Dizziness
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11.8%
2/17 • 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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Ear and labyrinth disorders
Tinnitus
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11.8%
2/17 • 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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Ear and labyrinth disorders
Loudness discomfort
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11.8%
2/17 • 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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General disorders
unsteady on feet
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5.9%
1/17 • 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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Ear and labyrinth disorders
map uncomfortable for high pitch sounds
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5.9%
1/17 • 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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General disorders
tightness around implant area
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5.9%
1/17 • 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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Ear and labyrinth disorders
redness and sensitivity at magnet site.
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5.9%
1/17 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place