Cochlear Sydney
Sydney, New South Wales, 2109, Australia
NCT Number: NCT04898673
The clinical study aims to investigate the speech performance with the CP1110 Sound Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction feature in the Automatic Scene Classifier..
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Sydney, New South Wales, 2109, Australia
The study will build on the evidence previously collected on behind-the-ear sound processors and noise reduction, with particular focus on the speech perception performance of the CP1110 Sound Processor when compared to the CP1000 Sound Processor.
To assess the primary and secondary speech perception objectives, the study incorporates a within-subject repeated-measures design in which each subject will undergo in-booth speech perception testing with all combinations of hardware and signal processing settings in a sound booth. The average difference scores will indicate the performance difference for each of the paired comparisons.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sound Processor
Sound Processor
Time frame: One day
Paired difference in dB SRT between treatment and control, with their applicable noise reduction feature enabled.
The speech recognition threshold (SRT) examines at which level the participant can repeat 50% of the speech material correctly. These scores may be negative or positive numeric values. Lower dB SRT scores indicate a better outcome.
Time frame: One day
Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
Secondary Endpoint 1: CNC Words correct in quiet (50 dB) with both CP1000 and CP1110 sound processors using Signal-to-Noise Ratio - Noise Reduction (SNR-NR) turned on.
Time frame: One day
Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
CNC Words in Quiet Score using both CP1110 and CP1000 sound processors Signal-to-Noise Ratio - Noise Reduction (SNR-NR) off with expander on.
Time frame: One Day
Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure.
Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
CNC Words in Quiet Score of CP1110 sound processor ForwardFocus ON (Moderate) vs CP1000 sound processor Signal-to-Noise Ration-Noise Reduction) On.
Cochlear
Industry
A Pre-Marketing, Prospective, Multi-Site, Open-Label, Within-Subject, Feasibility, Interventional Study of Speech Perception With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor and Compared With the CP1000 Sound Processor
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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