Clinical trial NCT06533774: Speech Locator_Benefits in Pediatric Popluations
Official title: SpeechSensor and StereoZoom for Pediatrics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 27
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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%

Primary outcomes:
measure: Speech intelligibility using AZBio sentences Verbal response accuracy based on percent of words correctly repeated on an open-set sentence recognition in noise task.
timeFrame: 3 hours
Secondary outcomes:
measure: 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.
timeFrame: 3 hours
measure: Preference for having slider
timeFrame: Up to 4 weeks
measure: Confidence and Anxiety
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Hearts for Hearing
state: Oklahoma
Study officials:
References: