Hearing DisordersEXTENDNCT03512951
Subjective Evaluation of a Sound Processing Method for Hearing Aids on Auditory Distance Perception
A study testing Digital signal processing algorithms in people with Hearing Disorders and Hearing Loss, Sensorineural, run by Sonova AG at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Disorders, Hearing Loss, Sensorineural
- What is being tested?
- Digital signal processing algorithms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 9 Oct 2018to 27 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Ecole Polytechnique Fédérale de Lausanne
Lausanne, Canton of Vaud, 1015
Ecole Polytechnique Fédérale de Lausanne
Lausanne, 1015
About this study
Official title: Subjective Evaluation of a Sound Externalization Method in Remote Microphone Systems for Binaural Hearing Aids With Respect to Auditory Distance Perception
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.
- Conditions
- Hearing Disorders, Hearing Loss, Sensorineural
- Being tested
- Digital signal processing algorithms
- Keywords
- Hearing aids, Remote microphone systems, Roger technology, Sound externalization, Auditory distance estimation
- Medical subject headings
- Hearing Disorders, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital signal processing algorithmsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Normal hearing | Experimental | 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. Receives: Other: Digital signal processing algorithms |
| 10 experienced hearing impaired | Experimental | 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. Receives: Other: Digital signal processing algorithms |
| 10 naive hearing impaired | Experimental | 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 Receives: Other: Digital signal processing algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start9 Oct 2018
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilles Courtois, Vincent Grimaldi, Eleftheria Georganti, Peter Derleth, David Sooprayen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512951
- Sponsor's protocol ID
- ID 2018-00709
- Acronym
- EXTEND
- Status last verified
- Dec 2018
- First submitted
- 17 Apr 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31774032
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Evaluation of a Sound Externalization Method in Remote Microphone Systems for Binaural Hearing Aids With Respect to Auditory Distance Perception
- ClinicalTrials.gov ID
- NCT03512951
- Acronym / sponsor ID
- EXTEND / ID 2018-00709
- Conditions
- Hearing Disorders, Hearing Loss, Sensorineural
- Keywords
- Hearing aids, Remote microphone systems, Roger technology, Sound externalization, Auditory distance estimation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Gilles Courtois, Vincent Grimaldi, Eleftheria Georganti, Peter Derleth, David Sooprayen
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal hearing | Experimental | Other: Digital signal processing algorithmsA 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. |
| 10 experienced hearing impaired | Experimental | Other: Digital signal processing algorithmsA 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. |
| 10 naive hearing impaired | Experimental | Other: Digital signal processing algorithmsA 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital signal processing algorithmsThe 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). | Other | 10 experienced hearing impaired, 10 naive hearing impaired, Normal hearing |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Derived from this study: PubMed 31774032Courtois 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital signal processing algorithms in people with Hearing Disorders and Hearing Loss, Sensorineural, run by Sonova AG at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory distance estimation (time frame: 6 months (study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018; AzTrials last refreshed its copy on 29 Oct 2026.