Hearing LossNCT06533774
Speech Locator_Benefits in Pediatric Popluations
A study testing Phonak Audéo Lumity 90-R in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Phonak Audéo Lumity 90-R
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Phonak Audéo Lumity 90-R
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phonak Audéo Lumity 90-RDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Phonak Audéo Lumity 90-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
- 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):
- 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.
Measured: 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.
Measured: 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).
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start8 Jun 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Why it stopped: Unreliable data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533774
- Sponsor's protocol ID
- eSRF: 7688
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpeechSensor and StereoZoom for Pediatrics
- ClinicalTrials.gov ID
- NCT06533774
- Acronym / sponsor ID
- eSRF: 7688
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unreliable data
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Audeo Lumity hearing aid with the SpeechSensor and StereoZoom 2.0 features | Experimental | Device: Phonak Audéo Lumity 90-RAudeo Lumity hearing aid and the SpeechSensor and StereoZoom 2.0 features, which is found in the Audeo Lumity devices. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phonak Audéo Lumity 90-RThis 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. | Device | Audeo Lumity hearing aid with the SpeechSensor and StereoZoom 2.0 features |
Primary outcome
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 secondary outcomes
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
Preference for having slider
Time frame: Up to 4 weeks
Confidence and Anxiety
Time frame: Up to 4 weeks
Results and safety
The study was stopped early (reason given: Unreliable data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonak Audéo Lumity 90-R in people with Hearing Loss, run by Sonova AG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unreliable data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.