Hearing Aid Performance Study for Different Spatial Configurations
NCT ID: NCT05284903
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2022-03-21
2022-07-05
Brief Summary
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Detailed Description
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This investigation is designed to extend the evaluation of hearing aid features to different spatial configuration and also to evaluate the benefit of the investigational device. The investigational device is European conformity (CE) marked and will be used within its defined use and on the intended population. The investigation is divided into three independent parts:
* Beamformer (BF) benefit: the first part of the study will evaluate the effect of a wider beamformer on intelligibility and listening effort for a speech-in-noise condition when the talker is not in front of the listener in comparison to a narrower beamformer,
* Speech Enhancer benefit: the second part of the study will evaluate the effect of the Speech Enhancer algorithm on distant speech in quiet and when speech in quiet is coming from an adjacent room with different measures such as listening effort, objective and subjective speech intelligibility,
* Hearing aid benefit: the third part of the study will evaluate the benefit provided by amplification with a speech-in-noise test where the talker is in front and close to the hearing aid user
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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Experimental: Phonak device with activated feature
The clinical investigation is designed to evaluate clinical performances in terms of speech intelligibility and listening effort. The expected benefit is based on clinical relevant differences. This clinical investigation is divided in three parts including Beamformer benefit, Speech Enhancer benefit and Hearing aid benefit (this part will be performed aided).
Beamformer Benefit: Speech intelligibility and Listening effort
Confirm the improvement in terms of speech intelligibility (measured by OLSA, Oldenburg Sentence Test) and the reduction in terms of listening effort (measured by ACALES) of the I-BF (investigational Beamformer) compared to the R-BF (reference Beamformer), when speech is not coming from the front.
Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility
Confirm the improvement in terms of speech intelligibility (measured by Oldenburg Sentence test) and the reduction in terms of listening effort (measured by ACALES) when the Speech Enhancer is on (SE ON) compared to Speech Enhancer is off (SE OFF) for distant speech or speech from adjacent room.
Confirm the improvement in terms of subjective level to follow a conversation in quiet when SE ON compared to SE OFF for distant speech or speech from adjacent room. Measured by a subjective assessment.
Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition)
Confirm the improvement in terms of speech intelligibility (measured by OLSA) in noise with the investigational device (aided condition) compared to the unaided condition.
Hearing aid benefit: Speech intelligibility in noise (aided condition)
Confirm the improvement in terms of speech intelligibility (measured by OLSA) with the Reference binaural beamformer compared to the fixed directional.
Comparator: Phonak device with deactivated feature
The comparative testings should be used as reference. The measures will be performed by the same participant group and the same three parts will be evaluated including Beamformer (BF) benefit, Speech Enhancer benefit and Hearing aid benefit. The reference will be performed without these features or with different settings of these features. In case of the Hearing aid benefit, the reference is an unaided fitting.
Beamformer Benefit: Speech intelligibility and Listening effort
Confirm the improvement in terms of speech intelligibility (measured by OLSA, Oldenburg Sentence Test) and the reduction in terms of listening effort (measured by ACALES) of the I-BF (investigational Beamformer) compared to the R-BF (reference Beamformer), when speech is not coming from the front.
Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility
Confirm the improvement in terms of speech intelligibility (measured by Oldenburg Sentence test) and the reduction in terms of listening effort (measured by ACALES) when the Speech Enhancer is on (SE ON) compared to Speech Enhancer is off (SE OFF) for distant speech or speech from adjacent room.
Confirm the improvement in terms of subjective level to follow a conversation in quiet when SE ON compared to SE OFF for distant speech or speech from adjacent room. Measured by a subjective assessment.
Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition)
Confirm the improvement in terms of speech intelligibility (measured by OLSA) in noise with the investigational device (aided condition) compared to the unaided condition.
Hearing aid benefit: Speech intelligibility in noise (aided condition)
Confirm the improvement in terms of speech intelligibility (measured by OLSA) with the Reference binaural beamformer compared to the fixed directional.
Interventions
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Beamformer Benefit: Speech intelligibility and Listening effort
Confirm the improvement in terms of speech intelligibility (measured by OLSA, Oldenburg Sentence Test) and the reduction in terms of listening effort (measured by ACALES) of the I-BF (investigational Beamformer) compared to the R-BF (reference Beamformer), when speech is not coming from the front.
Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility
Confirm the improvement in terms of speech intelligibility (measured by Oldenburg Sentence test) and the reduction in terms of listening effort (measured by ACALES) when the Speech Enhancer is on (SE ON) compared to Speech Enhancer is off (SE OFF) for distant speech or speech from adjacent room.
Confirm the improvement in terms of subjective level to follow a conversation in quiet when SE ON compared to SE OFF for distant speech or speech from adjacent room. Measured by a subjective assessment.
Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition)
Confirm the improvement in terms of speech intelligibility (measured by OLSA) in noise with the investigational device (aided condition) compared to the unaided condition.
Hearing aid benefit: Speech intelligibility in noise (aided condition)
Confirm the improvement in terms of speech intelligibility (measured by OLSA) with the Reference binaural beamformer compared to the fixed directional.
Eligibility Criteria
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Inclusion Criteria
* Adult (minimum age: 18 years) hearing aid users,
* Written and spoken German,
* Ability to understand instruction,
* Ability to describe listening experiences,
* Ability to attend to the appointments,
* Healthy outer ear,
* Hearing loss within the fitting ranges of the investigational product,
* Informed consent as documented by signature.
Exclusion Criteria
* Known hypersensitivity or allergy,
* Not willing to wear the hearing aid,
* Fluctuating hearing that could influence the results.
18 Years
ALL
No
Sponsors
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Sonova AG
INDUSTRY
Responsible Party
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Locations
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Hörzentrum Oldenburg gGmbH
Oldenburg, Lower Saxony, Germany
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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New implementation of directional beamforming configurations shows improved speech understanding and reduced listening effort
Other Identifiers
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SRF-386
Identifier Type: -
Identifier Source: org_study_id
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