- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02693704
Evaluation of a Binaural Spatialization Method for Hearing Aids (BHA(L&S))
Evaluation of a Binaural Spatialization Method for Hearing Aids, in Terms of Speech Intelligibility, Speaker Localization and Subjective Preference.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Lausanne, Switzerland, 1015
- Ecole Polytechnique Fédérale de Lausanne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Normal hearing
People showing no hearing loss (< 20 dB HL).
Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
|
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.
Other Names:
|
|
Experimental: Moderate hearing impaired
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 |
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.
Other Names:
|
|
Experimental: Severe hearing impaired
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 |
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.
Other Names:
|
|
Experimental: Profound hearing impaired
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 |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day of the experiment
|
|
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. |
1 day of the experiment
|
|
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.
|
1 day of the experiment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gilles Courtois, Enginner, Sonova AG
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHALS - 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sensorineural Hearing Loss
-
Oticon MedicalNot yet recruitingSensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound
-
Envoy Medical CorporationActive, not recruitingSensorineural Hearing Loss | Sensorineural Hearing Loss (Disorder) | Sensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound | Sensori-Neural DeafnessUnited States
-
Otologics LLCUnknownMixed Conductive and Sensorineural Hearing Loss, Bilateral
-
CochlearCompletedUnilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis) | Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral SideCanada
-
University College, LondonUnknownSensorineural Hearing Loss | Sensory Hearing Loss | Sensorineural Hearing Loss in Left Ear | Sensorineural Hearing Loss in Right Ear | Sensorineural HearingUnited Kingdom
-
Fundación Pública Andaluza para la gestión de la...RecruitingBilateral Sensorineural Hearing Loss | Unilateral Sensorineural Hearing LossSpain
-
Far East Bio-Tec Co., LtdNot yet recruitingTinnitus | Sudden Sensorineural Hearing Loss (SSNHL)Taiwan
-
Assiut UniversityNot yet recruitingSudden Sensorineural Hearing Loss (SSNHL)Egypt
-
Auris Medical, Inc.TerminatedHearing Loss, Idiopathic Sudden SensorineuralUnited States, Korea, Republic of, Canada
-
Manchester University NHS Foundation TrustUniversity of ManchesterCompletedCochlear Hearing Loss | Sensorineural Hearing Loss, BilateralUnited Kingdom
Clinical Trials on Hearing Aids
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHearing Loss, Sensorineural | Age-related Hearing LossChina
-
University Hospital, ToursCompletedHearing Loss | Alzheimer's DiseaseFrance
-
University of PretoriaChildren's Hospital Medical Center, Cincinnati; National Institute on Deafness...Recruiting
-
Sonova AGUniversity of South FloridaRecruitingHearing Loss, BilateralUnited States
-
Northwestern UniversityUniversity of Colorado, BoulderCompleted
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityActive, not recruitingCognitive Function and EEG Brain Network Remodeling Among Users of Hearing Aids With ARHL (EEG/ARHL)Depression | Sleep Disturbance | Age-related Cognitive Decline | Age-related Hearing LossChina
-
Jong Woo ChungCompletedAuditory Processing Disorder, CentralKorea, Republic of
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHearing Loss, Sensorineural | Cognitive Function Abnormal | Age-related Hearing Loss | Hearing AidChina
-
VA Office of Research and DevelopmentCompleted
-
Sonova AGWestern University, Canada; Sonova Canada Inc.Completed