Sensorineural Hearing LossPhase 2/3BHA(L&S)NCT02693704
Evaluation of a Binaural Spatialization Method for Hearing Aids
A Phase 2/3 study testing Hearing Aids in people with Sensorineural Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial summary
This study investigates the possible benefits of using binaural spatialization techniques in digital wireless microphone systems for hearing aids. Speech intelligibility tests, speaker localization tests and preference tests are performed. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- Hearing Aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2016to Jul 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- French-native speakers and adults.
- Normal otoscopy.
- No conductive pathology.
- Normal hearing, or moderate to severe, sloping or flat, symmetrical hearing loss.
- User of bilateral Phonak hearing aids, for more than 6 months (hearing-impaired only).
Who cannot join
- History of tinnitus or hyperacusis.
- Visual impairment, after correction with glasses or not.
- History of chronic or terminal illness or psychiatric disturbance,.
- History of epilepsy or other reactions associated with the proximity to a video screen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Binaural Spatialization Method for Hearing Aids, in Terms of Speech Intelligibility, Speaker Localization and Subjective Preference.
This study investigates the possible benefits of using binaural spatialization techniques in digital wireless microphone systems for hearing aids. Speech intelligibility tests, speaker localization tests and preference tests are performed. The results of a diotic (current rendering) and a binaural (suggested rendering) rendering are compared.
Read the detailed description
The signal processing laboratory (LTS2) of the Swiss Federal Institute of Technology (EPFL) has developed a new feature of sound rendering in hearing aids. This is a collaboration between EPFL and the Swiss company Phonak Communications AG. The new functionality works with the range of Roger products from Phonak, a new generation of FM systems that use a digital transmission.
FM technology refers to a type of wireless system that helps people better understand speech in noisy situations. FM systems commonly work together with a user's hearing aids, although systems are also available for those with otherwise normal hearing (such as people who suffer from APD, ADHD etc.). An FM system works like this: the person speaking wears or holds a transmitter microphone, or the transmitter is placed in the middle of the group (picking up speech from all around). Using harmless radio waves, the FM system sends speech signal(s) to the listener, who wears a tiny FM receiver behind the ear.
The new feature of such systems performs processing of the speaker's speech signal so that it renders information related to their spatial location. This so-called sound "spatialization" is a natural property of the human binaural auditory system, which allows us to localize sounds. However, this sound spatialization is not delivered by the current FM systems. Thanks to the new technology from EPFL and Phonak, it is now possible to include a binaural spatialization of the speech signal in the Roger product of Phonak hearing devices.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- Hearing Aids
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing AidsDevice
Also called Hearing instruments
The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment.
| Study group | Role | What they receive |
|---|---|---|
| Normal hearing | Experimental | People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP. Receives: Device: Hearing Aids |
| Moderate hearing impaired | Experimental | Patients showing moderate hearing loss (40-60 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro Receives: Device: Hearing Aids |
| Severe hearing impaired | Experimental | Patients showing severe hearing loss (60-80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro Receives: Device: Hearing Aids |
| Profound hearing impaired | Experimental | Patients showing profound hearing loss (> 80 dB HL).
Introduction of speech signal via the DAI of two hearing aids among:
PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro Receives: Device: Hearing Aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility
Speech recognition score (%) For each group: average of the SRS over all subjects in the group. The SRS correspond to the number of understood words in a sequence of sentences (French HINT database) mixed with several level of masking noise (speech-shaped noise). Some are played diotically, the other are spatialized in various directions. The goal is to ensure that the spatialization processing does not degrade the understanding of the speech.
Measured: 1 day of the experiment
Speaker's Localization
Localization error (in number of spatial sectors)
For each group: average localization error over all subjects in the group. It is the difference between the actual spatial sector and the one reported by the listeners. There were 5 spatial sectors, and 9 possible locations. For instance: if the stimuli is played in sector 4, and the listener perceives it in 2, then the localization error is |4-2| = 2. The goal is to compare the localization error in 3 conditions: 1/ with no hearing aids (reference of natural localization) and no spatialization 2/ with hearing aids and standard fittings and no spatialization, and 3/ with spatialization applied.
Measured: 1 day of the experiment
Listener's Subjective Preference
Listeners compare two audiovisual stimuli (diotic and spatialized) and Indicate their preference between binaural diotic (no spatialization), spatialized stimuli, or no preference. Results are given as the percentage of participant for the 3 possible answers in each group.
Measured: 1 day of the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing LossStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Gilles Courtois, Sonova AG
- Investigators
- Gilles Courtois, Enginner, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693704
- Sponsor's protocol ID
- BHALS - 001
- Acronym
- BHA(L&S)
- Status last verified
- Oct 2016
- First submitted
- 17 Feb 2016
- Last updated
- 4 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Courtois G, Lissek H, Estoppey P, Oesch Y, Gigandet X. Effects of Binaural Spatialization in Wireless Microphone Systems for Hearing Aids on Normal-Hearing and Hearing-Impaired Listeners. Trends Hear. 2018 Jan-Dec;22:2331216517753548. doi: 10.1177/2331216517753548.
PubMed 29457537
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Binaural Spatialization Method for Hearing Aids, in Terms of Speech Intelligibility, Speaker Localization and Subjective Preference.
- ClinicalTrials.gov ID
- NCT02693704
- Acronym / sponsor ID
- BHA(L&S) / BHALS - 001
- Conditions
- Sensorineural Hearing Loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Posted 4 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the possible benefits of using binaural spatialization techniques in digital wireless microphone systems for hearing aids. Speech intelligibility tests, speaker localization tests and preference tests are performed. The results of a diotic (current rendering) and a binaural (suggested rendering) rendering are compared.
Detailed description
The signal processing laboratory (LTS2) of the Swiss Federal Institute of Technology (EPFL) has developed a new feature of sound rendering in hearing aids. This is a collaboration between EPFL and the Swiss company Phonak Communications AG. The new functionality works with the range of Roger products from Phonak, a new generation of FM systems that use a digital transmission.
FM technology refers to a type of wireless system that helps people better understand speech in noisy situations. FM systems commonly work together with a user's hearing aids, although systems are also available for those with otherwise normal hearing (such as people who suffer from APD, ADHD etc.). An FM system works like this: the person speaking wears or holds a transmitter microphone, or the transmitter is placed in the middle of the group (picking up speech from all around). Using harmless radio waves, the FM system sends speech signal(s) to the listener, who wears a tiny FM receiver behind the ear.
The new feature of such systems performs processing of the speaker's speech signal so that it renders information related to their spatial location. This so-called sound "spatialization" is a natural property of the human binaural auditory system, which allows us to localize sounds. However, this sound spatialization is not delivered by the current FM systems. Thanks to the new technology from EPFL and Phonak, it is now possible to include a binaural spatialization of the speech signal in the Roger product of Phonak hearing devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal hearing | Experimental | Device: Hearing AidsPeople showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP. |
| Moderate hearing impaired | Experimental | Device: Hearing AidsPatients showing moderate hearing loss (40-60 dB HL). Introduction of speech signal via the DAI of two hearing aids among: PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro |
| Severe hearing impaired | Experimental | Device: Hearing AidsPatients showing severe hearing loss (60-80 dB HL). Introduction of speech signal via the DAI of two hearing aids among: PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro |
| Profound hearing impaired | Experimental | Device: Hearing AidsPatients showing profound hearing loss (> 80 dB HL). Introduction of speech signal via the DAI of two hearing aids among: PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- French-native speakers and adults.
- Normal otoscopy.
- No conductive pathology.
- Normal hearing, or moderate to severe, sloping or flat, symmetrical hearing loss.
- User of bilateral Phonak hearing aids, for more than 6 months (hearing-impaired only).
Key exclusion criteria (4 listed)
- History of tinnitus or hyperacusis.
- Visual impairment, after correction with glasses or not.
- History of chronic or terminal illness or psychiatric disturbance,.
- History of epilepsy or other reactions associated with the proximity to a video screen.
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 |
|---|---|---|
| Hearing AidsAlso: Hearing instrumentsThe only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment. | Device | Moderate hearing impaired, Normal hearing, Profound hearing impaired, Severe hearing impaired |
Primary outcome
Speech Intelligibility
Time frame: 1 day of the experiment
Speech recognition score (%) For each group: average of the SRS over all subjects in the group. The SRS correspond to the number of understood words in a sequence of sentences (French HINT database) mixed with several level of masking noise (speech-shaped noise). Some are played diotically, the other are spatialized in various directions. The goal is to ensure that the spatialization processing does not degrade the understanding of the speech.
Speaker's Localization
Time frame: 1 day of the experiment
Localization error (in number of spatial sectors) For each group: average localization error over all subjects in the group. It is the difference between the actual spatial sector and the one reported by the listeners. There were 5 spatial sectors, and 9 possible locations. For instance: if the stimuli is played in sector 4, and the listener perceives it in 2, then the localization error is |4-2| = 2. The goal is to compare the localization error in 3 conditions: 1/ with no hearing aids (reference of natural localization) and no spatialization 2/ with hearing aids and standard fittings and no spatialization, and 3/ with spatialization applied.
Listener's Subjective Preference
Time frame: 1 day of the experiment
Listeners compare two audiovisual stimuli (diotic and spatialized) and Indicate their preference between binaural diotic (no spatialization), spatialized stimuli, or no preference. Results are given as the percentage of participant for the 3 possible answers in each group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29457537Courtois G, Lissek H, Estoppey P, Oesch Y, Gigandet X. Effects of Binaural Spatialization in Wireless Microphone Systems for Hearing Aids on Normal-Hearing and Hearing-Impaired Listeners. Trends Hear. 2018 Jan-Dec;22:2331216517753548. doi: 10.1177/2331216517753548.
- 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.
Gilles Courtois, Enginner principal investigator
Sonova AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hearing Aids in people with Sensorineural Hearing Loss, run by Sonova AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Speech Intelligibility (time frame: 1 day of the experiment). The study lists 3 primary outcomes in all. 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 NCT02693704, 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 4 Oct 2016.