Speech Locator_Benefits in Pediatric Popluations

July 30, 2024 updated by: Sonova AG

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 3 hours

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 3 hours
  1. 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.
  2. 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
Time Frame: Up to 4 weeks
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
Time Frame: Up to 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sonova AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings