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PRINCE22 System Complete Performance Study

Primary Purpose

Hearing Loss, Bilateral, Hearing Loss, Unilateral

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test)
Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test)
Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)
Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale)
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Bilateral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hörzentrum Oldenburg gGmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Narrow reference beamformer

Novel beamformer approach

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
November 16, 2022
Last Updated
March 24, 2023
Sponsor
Sonova AG
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1. Study Identification

Unique Protocol Identification Number
NCT05656313
Brief Title
PRINCE22 System Complete Performance Study
Official Title
Feature Supporting Multitasking of Visual and Acoustical Objects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Bilateral, Hearing Loss, Unilateral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrow reference beamformer
Arm Type
Experimental
Arm Title
Novel beamformer approach
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Difference in speech recognition threshold between the reference beamformer and the novel (mean value of 10 repetitions).
Description
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.
Time Frame
4 weeks
Title
Difference in multitasking ability between the reference beamformer and the novel (1. Respond on two trigger words / 2. Respond on a target sign).
Description
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).
Time Frame
4 weeks
Title
Difference in subjective speech intelligibility between the reference beamformer and the novel (subjects rate his/her perception of the presented speech).
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Latzel
Organizational Affiliation
Sonova AG
Official's Role
Study Director
Facility Information:
Facility Name
Hörzentrum Oldenburg gGmbH
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26129
Country
Germany

12. IPD Sharing Statement

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PRINCE22 System Complete Performance Study

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