PRINCE22 System Complete Performance Study

Feature Supporting Multitasking of Visual and Acoustical Objects

The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise. The beamformer effect will be determined in terms of speech intelligibility, listening effort and ability to multitask when the talkers are located on the side or in the back.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Bilateral; Hearing Loss, Unilateral
• Intervention / Treatment: Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test); Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test); Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test); Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Oldenburg, Niedersachsen, Germany, 26129
      • Hörzentrum Oldenburg gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Experienced (minimum use duration 6 months)
• Adult (minimum age: 18 years) hearing aid users,
• Written and spoken German,
• Ability to understand instruction,
• Ability to perform tests successfully
• Ability to describe listening experiences,
• Ability to attend to the appointments,
• Healthy outer ear,
• Moderat to severe Hearing
• Informed consent as documented by signature.

Exclusion Criteria:

• Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
• Known hypersensitivity or allergy,
• Not willing to wear the hearing aid,
• Fluctuating hearing that could influence the results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Narrow reference beamformer	Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test); The Concurrent OLSA test (CC-OLSA) is a speech recognition test with three turn-taking talkers presenting sentences of the Oldenburg sentences test at fixed signal-to-noise ratios. CC-OLSA is the only one-talker-at-a-time speech test that is sensitive at the desired SNR and uses sentences with an intelligibility function with slopes of 10-17 %/dB.; Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test); The measure of the subjective speech recognition threshold is an alternative procedure to evaluate the subjective speech intelligibility in different listening conditions. The subjective speech recognition threshold is defined as the speech presentation level of running speech needed to just follow conversation. Subjects have to adjust the presentation level of speech so that they are just able to understand the speech, using a slider on a touch screen. This adjustment is repeated 10 times. Each adjustment results in a value for the subjective speech recognition threshold in dB SNR. The outcome measure is the mean value of the 10 repetitions. The HEISS-Test will be repeated four times for the secondary objective: test for 2 test conditions (Reference, novel approach) against 2 target directions (better ear side, back).; Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test); This test uses a dual-task-paradigm assessing vigilance for auditory and visual triggers concurrently. The primary task is to listen to a novel (Harry Potter) and respond on two trigger words by pressing the appropriate button (one in each hand). The secondary task is to observe a monitor showing a sequence of random signs and respond on a target sign by pressing both buttons. The test includes at least 100 triggers (50 auditory, 50 visual) and takes 10 minutes per condition (side vs. back; novel approach vs. reference; 40 minutes in total). The multitask test will be repeated four times for the secondary objective: 2 conditions (Refrence, novel approach) against 2 target directions (better ear side, back). Following data are provided from each multitask Test measure: (1) subjective rating of the perceived ability to perform the visual and the auditory test simultaneously. (2) reaction times to auditory and visual tasks, and (3) accuracy.; Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale); In addition to the tests mentioned above a subjective assessment will be used to determine the subjective perception as this measure is often a good indication for clinical relevance. For this purpose, the same speech material as used in the HEISS-test is presented by a loudspeaker in the same noisy environment as in the other three tests. The subjects rate his/her perception of the presented speech using a questionnaire on the dimensions "listen effort and speech intelligibility". The subject will rate his perception on the 100 point scale with pencils with different colors to get either absolute and relative ratings. The subjective assessment will be repeated four times for the secondary objective: 2 test conditions (Rference and novel approach) against 2 target directions (better ear side, back). Following data are provided from assessment: rating on a 100-point scale per condition and per dimension.
Active Comparator: Novel beamformer approach	Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test); The Concurrent OLSA test (CC-OLSA) is a speech recognition test with three turn-taking talkers presenting sentences of the Oldenburg sentences test at fixed signal-to-noise ratios. CC-OLSA is the only one-talker-at-a-time speech test that is sensitive at the desired SNR and uses sentences with an intelligibility function with slopes of 10-17 %/dB.; Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test); The measure of the subjective speech recognition threshold is an alternative procedure to evaluate the subjective speech intelligibility in different listening conditions. The subjective speech recognition threshold is defined as the speech presentation level of running speech needed to just follow conversation. Subjects have to adjust the presentation level of speech so that they are just able to understand the speech, using a slider on a touch screen. This adjustment is repeated 10 times. Each adjustment results in a value for the subjective speech recognition threshold in dB SNR. The outcome measure is the mean value of the 10 repetitions. The HEISS-Test will be repeated four times for the secondary objective: test for 2 test conditions (Reference, novel approach) against 2 target directions (better ear side, back).; Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test); This test uses a dual-task-paradigm assessing vigilance for auditory and visual triggers concurrently. The primary task is to listen to a novel (Harry Potter) and respond on two trigger words by pressing the appropriate button (one in each hand). The secondary task is to observe a monitor showing a sequence of random signs and respond on a target sign by pressing both buttons. The test includes at least 100 triggers (50 auditory, 50 visual) and takes 10 minutes per condition (side vs. back; novel approach vs. reference; 40 minutes in total). The multitask test will be repeated four times for the secondary objective: 2 conditions (Refrence, novel approach) against 2 target directions (better ear side, back). Following data are provided from each multitask Test measure: (1) subjective rating of the perceived ability to perform the visual and the auditory test simultaneously. (2) reaction times to auditory and visual tasks, and (3) accuracy.; Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale); In addition to the tests mentioned above a subjective assessment will be used to determine the subjective perception as this measure is often a good indication for clinical relevance. For this purpose, the same speech material as used in the HEISS-test is presented by a loudspeaker in the same noisy environment as in the other three tests. The subjects rate his/her perception of the presented speech using a questionnaire on the dimensions "listen effort and speech intelligibility". The subject will rate his perception on the 100 point scale with pencils with different colors to get either absolute and relative ratings. The subjective assessment will be repeated four times for the secondary objective: 2 test conditions (Rference and novel approach) against 2 target directions (better ear side, back). Following data are provided from assessment: rating on a 100-point scale per condition and per dimension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in speech intelligibility between the reference beamformer and the novel beamformer approach (percentage of correct responses in word recognition) in a noisy situation with speech from the side and from behind.	Two directional conditions (better ear side, back) and two beamformer conditions (Novel approach: SpeechSensor, Reference: StereoZoom) are tested (test and retest, eight measurements in total).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in speech recognition threshold between the reference beamformer and the novel (mean value of 10 repetitions).	Subjects have to adjust the presentation level of speech so that they are just able to understand the speech, using a slider on a touch screen. This adjustment is repeated 10 times. Each adjustment results in a value for the subjective speech recognition threshold in dB signal-to-noise ratio.	4 weeks
Difference in multitasking ability between the reference beamformer and the novel (1. Respond on two trigger words / 2. Respond on a target sign).	This test uses a dual-task-paradigm assessing vigilance for auditory and visual triggers concurrently. The primary task is to listen to a novel (Harry Potter) and respond on two trigger words by pressing the appropriate button (one in each hand). The secondary task is to observe a monitor showing a sequence of random signs and respond on a target sign by pressing both buttons. The test includes at least 100 triggers (50 auditory, 50 visual) and takes 10 minutes per condition (side vs. back; SpeechSensor vs. StereoZoom; 40 minutes in total).	4 weeks
Difference in subjective speech intelligibility between the reference beamformer and the novel (subjects rate his/her perception of the presented speech).	The subjects rate his/her perception of the presented speech using a questionnaire on the dimensions "listen effort and speech intelligibility". The subject will rate his perception on the 100 point scale with pencils with different colors to get either absolute and relative ratings. The subjective assessment will be repeated four times for the secondary objective: 2 test conditions (StereoZoom and SpeechSensor) against 2 target directions (better ear side, back). Following data are provided from assessment: rating on a 100-point scale per condition and per dimension.	4 weeks

Collaborators and Investigators

• Sponsor: Sonova AG
• Investigators: Study Director: Matthias Latzel, Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Bilateral; Hearing Loss, Unilateral
• Other Study ID Numbers: SRF-2391

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No