Evaluation of a Binaural Spatialization Method for Hearing Aids

Sensorineural Hearing Loss Clinical Trial

— BHA(L&S)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693704
• Other study ID #: BHALS - 001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 17, 2016
• Last updated: October 3, 2016
• Start date: February 2016
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Cantonal Office of Public Health
• Study type: Interventional

Clinical 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. The results of a diotic (current rendering) and a binaural (suggested rendering) rendering are compared.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• Hearing 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.

Locations

Country	Name	City	State
Switzerland	Ecole Polytechnique Fédérale de Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 day of the experiment	No
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.	1 day of the experiment	No
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.	1 day of the experiment	No