Adults 4 to 12, any sex, with Hearing Loss, Sensorineural or Hearing Loss, Bilateral. 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 Quiet Using CNC (Consonant-Nucleus-Consonant) Word ListsPrimary· Day 1 of 1 day study
One word list of 25 words is presented at 50 dB (quiet conditions) through a front speaker. The percent correctly repeated words are calculated and a higher score indicates better speech perception. The participants completed this task without hearing aids. Data was collected on both age groups, but analysis was completed only on the entire group as a whole. Age effects were not tested.
Percent words correct unaided, in quiet (50 dBA)
Group
Value
95% CI
Hearing Impaired Children Age 5-12
6.06
± 9.73
Percent words correct aided with SE off, in quiet ( 40 dBA)
Group
Value
95% CI
Hearing Impaired Children Age 5-12
53.7
± 13.02
Percent words correct, aided with SE moderate, in quiet (40 dBA)
Group
Value
95% CI
Hearing Impaired Children Age 5-12
66.61
± 11.92
Percent words correct, aided with SE strong, in quiet (40 dBA)
Group
Value
95% CI
Hearing Impaired Children Age 5-12
69.7
± 12
Percent words correct, aided SE off, in quiet (50 dBA)
Group
Value
95% CI
Hearing Impaired Children Age 5-12
74.7
± 9.1
Percent words correct, aided SE moderate, in quiet (50 dBA)
Group
Value
95% CI
Hearing Impaired Children Age 5-12
81.76
± 6.78
Percent words correct, aided SE strong, in quiet (50 dBA)
Group
Value
95% CI
Hearing Impaired Children Age 5-12
83.76
± 6.87
Subjective Ratings of Speech EnhancerSecondary· Day 1 of 1 day study
Participants will listen to a sound sample of looped sentences overlaid with low-level transient noise with the Speech Enhancer at different settings (off, moderate, strong) and rate their preference. An A/B comparison will be used to compare Speech Enhancer Off vs. Speech Enhancer Moderate, and Speech Enhancer Off vs. Speech Enhancer Strong. Participants answered three questions: 1) Which sounds better?, 2) Which is more comfortable?, and 3) Which do you prefer? Results will be reported as qualitative data and no statistical analysis will take place.
SE Moderate sounds better than SE Off
Group
Value
95% CI
Hearing Impaired Users Age 5 -12
10
SE Moderate sounds the same as SE Off
Group
Value
95% CI
Hearing Impaired Users Age 5 -12
16
SE Off sounds better than SE Moderate
Group
Value
95% CI
Hearing Impaired Users Age 5 -12
6
SE Moderate is more comfortable than SE Off
Group
Value
95% CI
Hearing Impaired Users Age 5 -12
6
SE Moderate is the same comfort as SE Off
Group
Value
95% CI
Hearing Impaired Users Age 5 -12
14
SE Off is more comfortable than SE Moderate
Group
Value
95% CI
Hearing Impaired Users Age 5 -12
12
Prefer SE Moderate to SE Off
Group
Value
95% CI
Hearing Impaired Users Age 5 -12
12
Prefer both SE Off and SE Moderate the same
Group
Value
95% CI
Hearing Impaired Users Age 5 -12
12
Sponsor's own description
Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable to provide adequate access to low-level auditory inputs from multiple talkers at a distance to capitalize on overhearing. A recent investigation by Jace Wolfe and colleagues showed that, even when aided, children with hearing loss had significantly poorer speech recognition at 40, 50 and 60 dBA compared to children with normal hearing. Furthermore, they showed that increasing hearing aid gain for very low-level inputs produced a statistically significant improvement in syllable-final plural recognition and a non-significant trend toward better monosyllabic word recognition at very low presentation levels. Additional research is needed to document low-level speech recognition ability of children with hearing loss as well as the potential benefit or detriment of increasing hearing aid gain for low-level inputs. A novel hearing aid technology known as Soft Speech Enhancer has been shown improve low-level speech perception in adults with hearing loss; however, the effect of Speech Enhancer on speech recognition in children is not yet known and will be evaluated.
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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Trials by the same sponsor.
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Sponsor: as reported to ClinicalTrials.gov by Sonova AG
Last refreshed: 14 December 2023
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/NCT05299892.