NCT06533774

Speech Locator_Benefits in Pediatric Popluations

SpeechSensor and StereoZoom for Pediatrics

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Sonova AG · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-06-08
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2024-08-01
• Last updated: 2024-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study