Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
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|ClinicalTrials.gov Identifier: NCT04723173|
Recruitment Status : Completed
First Posted : January 25, 2021
Results First Posted : February 17, 2022
Last Update Posted : March 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Device: Feature for noise reduction (on) Device: Feature for noise reduction (off)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Quality Control of CE-Certified Phonak Hearing Aids - 2020_43|
|Actual Study Start Date :||December 7, 2020|
|Actual Primary Completion Date :||May 11, 2021|
|Actual Study Completion Date :||June 7, 2021|
Experimental: Experimental device: Noise reduction on
The noise reduction is activated. The feature shall support the hearing aid user in noisy situation and shall reduce the listening effort in these special situations.
Device: Feature for noise reduction (on)
The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.
Active Comparator: Experimental device: Noise reduction off
To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature.
Device: Feature for noise reduction (off)
To show the advantage of the noise reduction feature there is a comparison without the feature necessary.
- Subjective Listening Effort Scaling [ Time Frame: 2 weeks ]
A listening effort scaling procedure ('ACALES'; Krueger et al, 2017) was performed with noise cancellation on and off.
ACALES is adaptive, altering the signal-to-noise ratio (SNR) at which speech is presented. Therefore it is not a simple rating scale.
For each stimulus, a rating (14-point scale ranging from 1='effortless' to 14= 'only noise') was given for how "effortful" it was following speech.
This results in 2-D data: a list of presentation SNRs (different for each participant), and respective participant ratings.
Given the format of this data, it cannot be summarized using standard descriptive statistics.
We defined SNR as the dependent variable and fitted a linear mixed effects model, with the predictors: listening effort rating & intervention (treating participants as a random factor), characterizing SNR over the entire rating scale.
The values reported represent the estimated marginal means of SNR for each intervention, averaged across effort ratings & participants.
- Subjective Ratings of Speech and Music Samples (Part1: Sound Quality) [ Time Frame: 4 weeks ]
The secondary Outcome measure of this study contains 2 parts. This first part reported here was the evaluation of the sound quality. A comparison was made between speech and music audio excerpts either with or without gain being increased by the feedback manager.
Subjective ratings of sound quality were made under both of these conditions for one speech and one music sample, using the following scale: Bad (1) - Poor (2) - Fair (3) - Good (4) - Excellent (5).
Results were analyzed separately for the speech and music samples.
- Measure of Detection Threshold (in dB) for Soft Sounds [ Time Frame: 2 weeks ]
This outcome measure evaluated the ability to detect sounds in a quiet environment.
A comparison was made between the feature under investigation being activated and deactivated.
Participants were asked to change the level of a speech sample until they were just able to detect it.
The ability will be measured by a detection threshold (in dB).
- Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception) [ Time Frame: 2 week ]
The second part of this secondary Outcome measure was the evaluation of audible artefacts either with or without the available gain being increased by the feedback manager.
The outcome was measured as a binary response (artefacts audible/ not audible). Participants had to indicate whether artefacts were audible under both of these conditions.
The number of positive ratings (artefacts were audible) was counted.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723173
|Stäfa, Zürich, Switzerland, 8712|