Clinical Evaluation of a Cochlear Implant Sound Processor
CompletedNAResults postedLast updated 13 May 2022
What this trial tests
NA trial testing Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software in Hearing Loss in 22 participants. Completed in 15 October 2020.
18 and older, any sex, with Hearing Loss or Ear Diseases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Speech Recognition in QuietPrimary· 1 Day
The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Baseline AutoSound
Group
Value
95% CI
EO Cohort
88.31
± 5.817
ARH Cohort
89.39
± 10.535
Baseline AutoSense
Group
Value
95% CI
EO Cohort
87.30
± 10.214
ARH Cohort
88.09
± 9.848
Speech Recognition in NoiseSecondary· 1 Day
Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
AutoSound
Group
Value
95% CI
EO Cohort
52.95
± 31.163
ARH Cohort
66.04
± 25.939
AutoSense
Group
Value
95% CI
EO Cohort
76.37
± 19.078
ARH Cohort
84.98
± 13.108
Increased Speech Recognition in NoiseSecondary· 1 Day
Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Omnidirectional
Group
Value
95% CI
EO Cohort
42.93
± 30.801
ARH Cohort
51.37
± 28.604
AutoSense
Group
Value
95% CI
EO Cohort
76.37
± 19.078
ARH Cohort
84.98
± 13.108
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit. The total period is up to 5 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Advanced Bionics
Last refreshed: 13 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04237207.