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

Primary Purpose

Hearing Disorders, Hearing Loss, Sensorineural

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Digital signal processing algorithms
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hearing Disorders focused on measuring Hearing aids, Remote microphone systems, Roger technology, Sound externalization, Auditory distance estimation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ecole Polytechnique Fédérale de Lausanne
  • Ecole Polytechnique Fédérale de Lausanne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Normal hearing

10 experienced hearing impaired

10 naive hearing impaired

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 17, 2018
Last Updated
December 19, 2018
Sponsor
Sonova AG
Collaborators
Gilles Courtois, Vincent Grimaldi, Eleftheria Georganti, Peter Derleth, David Sooprayen
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1. Study Identification

Unique Protocol Identification Number
NCT03512951
Brief Title
Subjective Evaluation of a Sound Processing Method for Hearing Aids on Auditory Distance Perception
Acronym
EXTEND
Official Title
Subjective Evaluation of a Sound Externalization Method in Remote Microphone Systems for Binaural Hearing Aids With Respect to Auditory Distance Perception
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
November 27, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Gilles Courtois, Vincent Grimaldi, Eleftheria Georganti, Peter Derleth, David Sooprayen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Disorders, Hearing Loss, Sensorineural
Keywords
Hearing aids, Remote microphone systems, Roger technology, Sound externalization, Auditory distance estimation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal hearing
Arm Type
Experimental
Arm Description
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.
Arm Title
10 experienced hearing impaired
Arm Type
Experimental
Arm Description
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.
Arm Title
10 naive hearing impaired
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Digital signal processing algorithms
Intervention Description
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 Measure Information:
Title
Auditory distance estimation
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Ecole Polytechnique Fédérale de Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1015
Country
Switzerland
Facility Name
Ecole Polytechnique Fédérale de Lausanne
City
Lausanne
ZIP/Postal Code
1015
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31774032
Citation
Courtois G, Grimaldi V, Lissek H, Estoppey P, Georganti E. Perception of Auditory Distance in Normal-Hearing and Moderate-to-Profound Hearing-Impaired Listeners. Trends Hear. 2019 Jan-Dec;23:2331216519887615. doi: 10.1177/2331216519887615.
Results Reference
derived

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

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