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Subjective Evaluation of a Sound Processing Method for Hearing Aids on Auditory Distance Perception (EXTEND)

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ClinicalTrials.gov Identifier: NCT03512951
Recruitment Status : Active, not recruiting
First Posted : May 1, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
Gilles Courtois
Vincent Grimaldi
Eleftheria Georganti
Peter Derleth
David Sooprayen
Information provided by (Responsible Party):
Sonova AG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hearing Disorders Hearing Loss, Sensorineural Other: Digital signal processing algorithms Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Subjective Evaluation of a Sound Externalization Method in Remote Microphone Systems for Binaural Hearing Aids With Respect to Auditory Distance Perception
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normal hearing
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
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).

Experimental: 10 experienced hearing impaired
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
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).

Experimental: 10 naive hearing impaired
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).




Primary Outcome Measures :
  1. Auditory distance estimation [ Time Frame: 6 months (study completion) ]
    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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Subjects fulfilling all of the following inclusion criteria are eligible for the study:

  • Willing and able to give written informed consent as documented by signature,
  • French-native adult speakers,
  • (Preferably) younger than 60 y.o.

For all normal-hearing participants:

- Hearing thresholds lower or equal to 20 dB on both ears, as ensured by a pure-tone audiometry (125 Hz to 8 kHz) conducted at the beginning of the session.

For all hearing-impaired patients:

  • Patients of Mr. Philippe Estoppey, private audiologist settled in Lausanne,
  • User of bilateral BTE Phonak hearing aids, commercialized after July 2012, with fittings that did not change over the last three months,
  • Presenting a severe-to-profound sensorineural hearing loss,
  • Presenting a symmetrical hearing loss (no bilateral hearing threshold that differ by more than 20 dB at any audiometric frequency (125 Hz - 4 kHz)).

For HI patients experienced with remote microphone systems:

- Past or present users of FM and/or Roger devices for more than six months.

For other HI patients:

- No past or present experience with FM and/or Roger devices for more than one month.

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

  • Collaborator of the laboratory (LTS2) or student attending the courses of audio and acoustics given by the laboratory staff (EE-348 Electroacoustics, EE-548 Audio Engineering),
  • History of chronic or terminal illness, psychiatric disturbance, senile dementia, or cognitive impairment,
  • History of strong tinnitus and/or hyperacusis,
  • Strong visual impairment after correction with glasses or not,
  • History of epilepsy or other reactions associated with the proximity to a screen,
  • Motor disability that would disturb their presence at EPFL.

Information from the National Library of Medicine

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): NCT03512951


Locations
Switzerland
Ecole Polytechnique Fédérale de Lausanne
Lausanne, Vaud, Switzerland, 1015
Ecole Polytechnique Fédérale de Lausanne
Lausanne, Switzerland, 1015
Sponsors and Collaborators
Sonova AG
Gilles Courtois
Vincent Grimaldi
Eleftheria Georganti
Peter Derleth
David Sooprayen

Responsible Party: Sonova AG
ClinicalTrials.gov Identifier: NCT03512951     History of Changes
Other Study ID Numbers: ID 2018-00709
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sonova AG:
Hearing aids
Remote microphone systems
Roger technology
Sound externalization
Auditory distance estimation

Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms