Speech Locator_Benefits in Pediatric Popluations

SpeechSensor and StereoZoom for Pediatrics

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.

Study Overview

• Status: Terminated
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phonak Audéo Lumity 90-R

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Hearts for Hearing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.; Initial - Personalized Signal-to-Noise-Ratio (SNR) is determined for each participant by finding the point where the participant scores 50% correct individual words within sentences. The personalized SNR is determined from the average of two list for a given condition. (SpeechSensor and SZ2.0 objectives); For comparison conditions - Speech as noise will be presented at the participant's personalized SNR. Speech intelligibility will be determined by accuracy of individual words within sentences. The total words correct is determined for a single list for each condition. (Aided versus unaided, intended use objective).	3 hours

Secondary Outcome Measures

Outcome Measure	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.	Ability to use slider in the app will be determined on the basis of successfully or not successfully completing a single task, "In a situation when you want to use the app, show me what you would do." The child will be reinstructed one time and must successfully perform the desired task to be eligible for the home trial.; Ability to successfully use slider in the app will be determined based on successful execution of all of the following tasks correctly): 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.	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

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: eSRF: 7688

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes