This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants. Programming a cochlear implant-commonly referred to as MAP fitting-involves activating the device, allowing recipients to acclimatize to hearing sounds, and then fine-tuning the program based on the user's perception of loudness across different sounds. This process typically occurs over several visits and requires a clinician to collect data for the fine-tuning phase. The Nexus Research System includes an "Electrical Loudness Scaling" task, which participants can complete independently using a mobile application to collect the necessary data. Based on findings from previous studies, this feature has been revised to enable faster data collection. The current study will assess the performance of the updated feature. The study will involve experienced cochlear implant users. Participants will use the feature, undergo a series of hearing assessments-including evaluations of loudness perception-and provide feedback on the updated feature.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
The Standard-ELS task is conducted using the Mobile Research Application within the Nexus Research system. It is completed in two phases: the first phase identifies the lower and upper bounds of the loudness range based on participant ratings, while the second phase collects data from stimulations delivered within the established range.
The Fast-ELS task employs an algorithm to estimate the lower and upper bounds of the loudness range using a limited number of samples. This range is then refined by collecting additional samples across various loudness categories for comprehensive coverage.
Cochlear Denver Research Centre
Lone Tree, Colorado, United States
Cochlear Technology Centre Belgium
Mechelen, Mechelen, Belgium
European Institute for Otorhinolaryngology (EIORL), ENT Department, Sint-Augustinus Antwerp
Antwerp, Belgium
Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one on-site session.
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.
Time frame: Day 0, Day 14
Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one on-site session.
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.
Time frame: Day 0, Day 14
Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one at home session.
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.
Time frame: Day 0 - Day 14
Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one at home session.
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.
Time frame: Day 0 - Day 14
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session on-site.
Test-retest reliability of Fast-ELS outcomes to very soft sounds obtained within one session on-site.
Time frame: Day 0, Day 14
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session at home.
Test-retest reliability of Fast-ELS outcomes to very soft sounds obtained within one session at home.
Time frame: Day 0 - Day 14
Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session on-site.
Test-retest reliability of Fast-ELS outcomes to loud sounds obtained within one session on-site.
Time frame: Day 0, Day 14
Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session at home.
Test-retest reliability of Fast-ELS outcomes to loud sounds obtained within one session at home.
Time frame: Day 0 - Day 14
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS obtained during multiple sessions on-site.
Test-retest reliability of Fast-ELS outcomes to very soft sounds obtained during multiple sessions on-site.
Time frame: 14 days
Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS obtained during multiple sessions at home.
Test-retest reliability of Fast-ELS outcomes to very soft sounds obtained during multiple sessions at home.
Time frame: 14 days
Correlation coefficient of very soft sounds (loudness category 35) obtained with Fast-ELS obtained during multiple sessions on-site.
Test-retest reliability of Fast-ELS outcomes to loud sounds obtained during multiple sessions on-site.
Time frame: 14 days
Correlation coefficient of very soft sounds (loudness category 35) obtained with Fast-ELS obtained during multiple sessions at home.
Test-retest reliability of Fast-ELS outcomes to loud sounds obtained during multiple sessions at home.
Time frame: 14 days
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