N/A
Completed N=19
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
Source: ClinicalTrials.gov NCT04578457 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Differences in Event-related-skin-conductance — 0.221; 0.189; 0.147; 0.126 micro Siemens
Summary
Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort & performance following each condition. During this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a one factor (algorithm), within-subjects design.
Each participant performs the Speech perception task with each algorithm (reference, noise reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be collected.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Event-related-skin-conductance |
0.221; 0.189; 0.147; 0.126 | — |
| PRIMARY Differences in Event-related-pupil-dilation (ERPDs) |
217.713; 217.301; 158.732; 186.526 | — |
| SECONDARY Oldenburg Sentence Test |
92.778; 88.611; 96.157; 94.398 | — |
| SECONDARY Sound Quality Ratings |
3.275; 3.230; 3.054; 3.157 | — |
| SECONDARY Spectro-temporal-modulation Detection Thresholds (STM) |
-8.181 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
- Minimum 1 year hearing aid experience
- Moderate-Severe (N3-N5) hearing loss or Normal Hearing
Exclusion Criteria
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known central hearing disorders
Data sourced from ClinicalTrials.gov (NCT04578457). 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. Informational only — not medical advice.