An interventional study of Digital signal processing algorithms in Hearing Disorders and Hearing Loss, Sensorineural, sponsored by Sonova AG. Completed at 2 sites in Switzerland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-20.
Sponsored by Sonova AG · Not applicable, Interventional, and Supportive care
Within the course of this study, a signal processing feature has been developed at Ecole Polytechnique Fédérale de Lausanne (EPFL), in collaboration with Sonova AG, in order to enhance the listening experience with remote microphone systems. In particular, the developed feature is supposed to improve the so-called audio-visual fusion, i.e. the fact to perceive the sound as coming from the physical location of the source. One of the main goals of the present study is to evaluate the extent to which this feature reaches that objective.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
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Of its 25 completed or terminated interventional studies of FDA-regulated products, 17 (68%) have results posted.
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Subjects fulfilling all of the following inclusion criteria are eligible for the study:
For all normal-hearing participants:
For all hearing-impaired patients:
For HI patients experienced with remote microphone systems:
For other HI patients:
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
A control group including ten normal-hearing participants. These participants are recruited because they can be considered as a reference when compared to hearing-impaired patients. They usually provide homogeneous results that are expected to be significantly different than those obtained with hearing-impaired patients. In this study, normal-hearing participants are expected to provide better and more consistent performance of auditory distance estimation.
Other: Digital signal processing algorithms
A group of ten (expected sample size) severe-to-profound hearing-impaired patients who have a past and/or present experience of more than 6 months with remote microphone systems. These patients are expected to be aware of the drawbacks of the current remote microphone technology with respect to sound localization, auditory distance estimation, and audio-visual fusion.
Other: Digital signal processing algorithms
A group of ten severe-to-profound hearing-impaired patients with no past or current experience with remote microphone systems. They are referred to as naïve patients. These patients must have similar profiles to the patients in the experienced group as regards the degree of hearing loss, origin of hearing loss (congenital, pre- or post-lingual disability), age, gender, and hearing aid technology. They will be selected and recruited on the basis of the patients included in experienced group
Other: Digital signal processing algorithms
The intervention consists in applying five processing on some recorded speech signals. In particular, the processing performed by one specific algorithm is compared against the four other. The applied processing is supposed to restore sound externalization (expected audio-visual fusion).
Auditory distance estimation
This objective is assessed by using a single outcome, which is the perceived auditory distance, as reported by the patient on a graphical user interface. The auditory distance is measured using an arbitrary scale (between 1 and 5) as available with sliders on a graphical user interface (GUI).
Time frame: 6 months (study completion)
Plan to share: No
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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