Evaluation of a Binaural Spatialization Method for Hearing Aids

NCT02693704 | Completed Phase 2 Results

• 1 other identifier: BHALS - 001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 day of the experiment

Study Arms (4)

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.

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

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

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

Device: Hearing Aids

Interventions

Hearing Aids DEVICE

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.

Also known as: Hearing instruments

Moderate hearing impaired; Normal hearing; Profound hearing impaired; Severe hearing impaired

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Ecole Polytechnique Fédérale de Lausanne

Lausanne, 1015, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 29457537 DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Results Point of Contact

• Title: Gilles Courtois
• Organization: EPFL

gilles.courtois@epfl.ch

0041216932631

Study Officials

• Gilles Courtois, Enginner

  Sonova AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 29, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 4, 2016
• Results First Posted: October 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)