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The study seeks to evaluate the impact of SpeechSensor and StereoZoom 2.0 on speech understanding in noise in dynamic listening conditions in pediatric hearing aid users.
The purpose of this study is to substantiate clinical performance claims regarding the benefit of the SpeechSensor feature on speech recognition in noise for side and rear speech as well as StereoZoom 2.0 benefit data for front speech in noise. In addition, the study will yield myPhonak app usability data and claims regarding children's impressions (confidence, anxiety) when given the opportunity to personalize their beamformer settings in noise during a home trial. Finally, this work will confirm hearing aid intended use for pediatric hearing aid users. Results will inform feature setting, provide critical post-market clinical hearing aid data and support for claims.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audeo Lumity hearing aid with the SpeechSensor and StereoZoom 2.0 features | Experimental | Audeo Lumity hearing aid and the SpeechSensor and StereoZoom 2.0 features, which is found in the Audeo Lumity devices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonak Audéo Lumity 90-R | Device | This study will be using the Audeo L90-R devices, which are programmed by the hearing care professional (HCP) using Target fitting software version 8.1. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech intelligibility using AZBio sentences Verbal response accuracy based on percent of words correctly repeated on an open-set sentence recognition in noise task. | Verbal response accuracy based on percent of words correctly repeated on an open-set sentence recognition in noise task.
| 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Focus Slider Usability - Performance on a modified PHAST (Practical Hearing Aid Skills Test) tool will be used to document whether participants can successfully modify the Speech Focus slider. |
i. Show me what you would do to better hear a person in front; ii. Show me what you would do to hear more of the sounds around you. iii. Demonstrate what you should do when you leave the situation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hearts for Hearing | Oklahoma City | Oklahoma | 73120 | United States |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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This clinical investigation is an interventional study, executed at one investigation site, with a confirmatory design. The investigation model is single group, with a randomized test order where the test conditions are fully crossed-over.
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For objectives 1-3, it is single blinded because all test conditions are implemented in the same hearing aid with the beamformer setting being unknown to the test participant but known to the investigator who enacts program changes.
For the remaining objectives (4-8), it is non-blinded as participants will be trained on the app before completing a skills test (4), will compare impressions using versus not using the app to change their beamformer (5-7) and speech understanding with versus without amplification (8).
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| 3 hours |
| Preference for having slider | Preference for having the Speech Focus slider accessible via the app will be documented with a Yes/ No question on a subjective questionnaire administered post-home trial. | Up to 4 weeks |
| Confidence and Anxiety | The possible impact of having access to the Speech Focus slider on confidence and anxiety will be measured using subjective ratings on a post-home trial questionnaire (i.e., Likert scale). | Up to 4 weeks |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |