Speech Locator_Benefits in Pediatric Popluations

Sonova

Status: Terminated

Conditions: Hearing Loss

Treatments: Device: Phonak Audéo Lumity 90-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT06533774

eSRF: 7688

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Audeo Lumity hearing aid with the SpeechSensor and StereoZoom 2.0 features

Experimental group

Description:

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

Treatment:

Device: Phonak Audéo Lumity 90-R