Speech Locator_Benefits in Pediatric Popluations

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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).

Study Groups

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Audeo Lumity hearing aid with the SpeechSensor and StereoZoom 2.0 features

Audeo Lumity hearing aid and the SpeechSensor and StereoZoom 2.0 features, which is found in the Audeo Lumity devices.

Group Type EXPERIMENTAL

Phonak Audéo Lumity 90-R

Intervention Type 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.

Interventions

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Phonak Audéo Lumity 90-R

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Experienced (\> 6 months), full-time hearing aid user
* 10 years up to but not including 18 years of age
* Spoken English
* Ability to understand oral instruction
* Ability to describe listening experiences
* No known neurological issues or cognitive impairment
* Ability to attend the in-person appointment(s)
* No speech/language deficits that could compromising ability to perform tasks
* Healthy outer and middle ear
* Hearing loss consistent with fitting range of the investigational product
* Access to a smartphone that can be used during a home trial
* Informed consent (signature) of parent and consent or assent (verbal) of child

Exclusion Criteria

* Clinical contraindications (e.g., closed ear canal, absence of pinna)
* Known hypersensitivity or allergy to materials comprising hear-ing aid or acoustic coupling
* Unwilling to wear the hearing aid
* Unwilling or not permitted to use a smartphone
* Aided open-set aided speech recognition scores for speech front (+15 dB SNR) \< 30%

Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No