Speech Locator_Benefits in Pediatric Popluations

NCT06533774 | Terminated FDA Device

• 1 other identifier: eSRF: 7688
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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. 1. 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) 2. 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 Outcomes (3)

• 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.

  3 hours

• Preference for having slider

  Up to 4 weeks

• Confidence and Anxiety

  Up to 4 weeks

Study Arms (1)

Audeo Lumity hearing aid with the SpeechSensor and StereoZoom 2.0 features

EXPERIMENTAL

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

Interventions

Phonak Audéo Lumity 90-R 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.

Audeo Lumity hearing aid with the SpeechSensor and StereoZoom 2.0 features

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Experienced (\> 6 months), full-time hearing aid user
• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Hearts for Hearing

Oklahoma City, Oklahoma, 73120, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: June 8, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: August 1, 2024

Record last verified: 2023-08

Locations

US (1)