N/A
N=16
Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT05150964 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Speech Reception Threshold — 27; 27; 24; 24 dB HL (decibels hearing level) — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Phonak Audeo hearing aid (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Sonova AG
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Reception Threshold |
27; 27; 24; 24 | <0.05 sig |
| PRIMARY Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL. |
52; 63; 69; 75; 92; 95 | <0.05 sig |
| PRIMARY Multi-word Recognition at 40 dB SPL and 70 dB SPL |
48; 56; 51; 54; 66; 67 | <0.05 sig |
| PRIMARY Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. |
65; 68; 73; 71; 89; 87 | <0.05 sig |
| PRIMARY Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. |
68; 76; 70; 73; 69; 73 | >0.05 |
| PRIMARY Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula |
2; 2; 7; 3 | — |
Summary
Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents.
Eligibility Criteria
Inclusion Criteria
- clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss
- Must use oral mode of communication
- must speak English
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT05150964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.