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Evaluation of a Binaural Spatialization Method for Hearing Aids

Evaluation of a Binaural Spatialization Method for Hearing Aids, in Terms of Speech Intelligibility, Speaker Localization and Subjective Preference.

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02693704
Acronym
BHA(L&S)
Enrollment
40
Registered
2016-02-29
Start date
2016-02-29
Completion date
2016-07-31
Last updated
2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural Hearing Loss

Brief 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. 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.

Interventions

DEVICEHearing Aids

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.

Sponsors

Sonova AG
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Speech Intelligibility1 day of the experimentSpeech 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 Localization1 day of the experimentLocalization 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 Preference1 day of the experimentListeners 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.

Countries

Switzerland

Participant flow

Participants by arm

ArmCount
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.
10
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
10
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
10
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
10
Total40

Baseline characteristics

CharacteristicModerate Hearing ImpairedSevere Hearing ImpairedNormal HearingProfound Hearing ImpairedTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants6 Participants0 Participants1 Participants11 Participants
Age, Categorical
Between 18 and 65 years
6 Participants4 Participants10 Participants9 Participants29 Participants
Age, Continuous51 years
STANDARD_DEVIATION 24
63 years
STANDARD_DEVIATION 20
21 years
STANDARD_DEVIATION 2
38 years
STANDARD_DEVIATION 18
43 years
STANDARD_DEVIATION 23
Region of Enrollment
Switzerland
10 participants10 participants10 participants10 participants40 participants
Sex: Female, Male
Female
3 Participants5 Participants5 Participants6 Participants19 Participants
Sex: Female, Male
Male
7 Participants5 Participants5 Participants4 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 100 / 100 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 100 / 10

Outcome results

Primary

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.

Time frame: 1 day of the experiment

ArmMeasureGroupValue (NUMBER)
Normal HearingListener's Subjective PreferenceDiotic60 Percentage of participants
Normal HearingListener's Subjective PreferenceNo preference5 Percentage of participants
Normal HearingListener's Subjective PreferenceSpatialization35 Percentage of participants
Moderate Hearing ImpairedListener's Subjective PreferenceDiotic50 Percentage of participants
Moderate Hearing ImpairedListener's Subjective PreferenceSpatialization35 Percentage of participants
Moderate Hearing ImpairedListener's Subjective PreferenceNo preference15 Percentage of participants
Severe Hearing ImpairedListener's Subjective PreferenceNo preference15 Percentage of participants
Severe Hearing ImpairedListener's Subjective PreferenceDiotic45 Percentage of participants
Severe Hearing ImpairedListener's Subjective PreferenceSpatialization40 Percentage of participants
Profound Hearing ImpairedListener's Subjective PreferenceNo preference20 Percentage of participants
Profound Hearing ImpairedListener's Subjective PreferenceSpatialization50 Percentage of participants
Profound Hearing ImpairedListener's Subjective PreferenceDiotic30 Percentage of participants
Primary

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.

Time frame: 1 day of the experiment

ArmMeasureGroupValue (MEAN)Dispersion
Normal HearingSpeaker's LocalizationSpatialized localization0.45 Localization error (# spatial sectors)Standard Deviation 0.09
Normal HearingSpeaker's LocalizationAided localization0.3 Localization error (# spatial sectors)Standard Deviation 0.1
Normal HearingSpeaker's LocalizationUnaided localization0.13 Localization error (# spatial sectors)Standard Deviation 0.04
Moderate Hearing ImpairedSpeaker's LocalizationSpatialized localization0.54 Localization error (# spatial sectors)Standard Deviation 0.08
Moderate Hearing ImpairedSpeaker's LocalizationUnaided localization0.45 Localization error (# spatial sectors)Standard Deviation 0.11
Moderate Hearing ImpairedSpeaker's LocalizationAided localization0.33 Localization error (# spatial sectors)Standard Deviation 0.08
Severe Hearing ImpairedSpeaker's LocalizationAided localization0.57 Localization error (# spatial sectors)Standard Deviation 0.07
Severe Hearing ImpairedSpeaker's LocalizationUnaided localization0.5 Localization error (# spatial sectors)Standard Deviation 0.06
Severe Hearing ImpairedSpeaker's LocalizationSpatialized localization0.75 Localization error (# spatial sectors)Standard Deviation 0.21
Profound Hearing ImpairedSpeaker's LocalizationUnaided localization2.02 Localization error (# spatial sectors)Standard Deviation 0.38
Profound Hearing ImpairedSpeaker's LocalizationAided localization1.74 Localization error (# spatial sectors)Standard Deviation 0.34
Profound Hearing ImpairedSpeaker's LocalizationSpatialized localization1.65 Localization error (# spatial sectors)Standard Deviation 0.4
Primary

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.

Time frame: 1 day of the experiment

ArmMeasureGroupValue (MEAN)Dispersion
Normal HearingSpeech IntelligibilityDiotic Rendering63 Percentage of understood wordStandard Deviation 4
Normal HearingSpeech IntelligibilitySpatialized rendering68 Percentage of understood wordStandard Deviation 3
Moderate Hearing ImpairedSpeech IntelligibilitySpatialized rendering67 Percentage of understood wordStandard Deviation 6
Moderate Hearing ImpairedSpeech IntelligibilityDiotic Rendering60 Percentage of understood wordStandard Deviation 6
Severe Hearing ImpairedSpeech IntelligibilityDiotic Rendering59 Percentage of understood wordStandard Deviation 6
Severe Hearing ImpairedSpeech IntelligibilitySpatialized rendering66 Percentage of understood wordStandard Deviation 7
Profound Hearing ImpairedSpeech IntelligibilityDiotic Rendering48 Percentage of understood wordStandard Deviation 12
Profound Hearing ImpairedSpeech IntelligibilitySpatialized rendering47 Percentage of understood wordStandard Deviation 9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026