Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users

A study testing Phonak Audeo hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents. Read more about this study

Who is it for?: Ages 8 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Hearing Loss
What is being tested?: Phonak Audeo hearing aid
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2021to 29 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 8 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss
Must use oral mode of communication
must speak English

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Arizona State University
Tempe, Arizona, 85281

Other trials in United States

About this study

Official title: Measuring Comfort and Clarity Using Low Gain Feature in Pediatric Hearing Aid Users

Conditions: Hearing Loss
Being tested: Phonak Audeo hearing aid
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 Audeo hearing aidDevice
receiver in the canal devices with custom earmolds

Study groups in NCT05150964
Study group	Role	What they receive
Experimental	Experimental	One group will be fit with commercially available hearing aids that will have different program settings Receives: Device: Phonak Audeo hearing aid

What is being measured

The primary outcome is the main question the study is designed to answer.

Speech Reception Threshold
A familiar spondee word list is presented at varying dB (decibel) levels. Threshold is defined as the lowest dB level at which a correct response occurs for two out of three ascending trials. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session, and counterbalanced across participants. Each session consisted of testing with the ASG (Adaptive Situational Gain) feature on and off. The lower the number (dB level), the softer the participant is able to repeat the words correctly two out of three times.
Measured: Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)
Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
Familiar monosyllabic word list presented at 40 dB and 70 dB. Percentage of words correctly repeated is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. The higher the score, the better the word recognition in each condition.
Measured: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Multi-word Recognition at 40 dB SPL and 70 dB SPL
Out of a list of seven words, the participant repeats back as many words as they can recall. Percentage of correct words repeated back is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. One fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. A higher percentage score indicates better multi-word recognition.
Measured: Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)
Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
A list of 10 3-word phrases are presented to the participant. The participant indicates if the phrase contains a nonsense word by selecting the numbered response button (i.e. "1", "2", or "3") that corresponds to the position oof the nonsense word in the phrase. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. . The score is the percent correct, a higher score is better.
Measured: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
A word learning task used to determine participant's ability to associate novel/nonsense words with novel images as rapidly as possible. Five nonsense words are paired with five novel images displayed on response buttons. The words are presented randomly 10 times each. The participant selects one picture per word. Scores are presented as percent correct. A higher percentage indicates better word learning. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off.
Measured: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.
Measured: 2nd appointment (day 14 of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202129 May 2022

First posted9 Dec 2021
Study start1 Jun 2021
Primary completion15 Oct 2021
Study completion29 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05150964
Sponsor's protocol ID: SRF-379
Status last verified: May 2023
First submitted: 28 Sep 2021
Last updated: 19 May 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measuring Comfort and Clarity Using Low Gain Feature in Pediatric Hearing Aid Users
ClinicalTrials.gov ID: NCT05150964
Acronym / sponsor ID: SRF-379
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Sonova AGIndustry (pharma, biotech, devices)
Collaborators: Arizona State University
Study start: 1 Jun 2021 (actual)
Primary completion: 15 Oct 2021 (actual)
Study completion: 29 May 2022 (actual)
First posted: 9 Dec 2021 (actual)
Results: Posted 19 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Device: Phonak Audeo hearing aidOne group will be fit with commercially available hearing aids that will have different program settings

Who may qualify

Ages: 8 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss
Must use oral mode of communication
must speak English

Key exclusion criteria (1 listed)

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 Audeo hearing aidreceiver in the canal devices with custom earmolds	Device	Experimental

Primary outcome

Speech Reception Threshold
Time frame: Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)
A familiar spondee word list is presented at varying dB (decibel) levels. Threshold is defined as the lowest dB level at which a correct response occurs for two out of three ascending trials. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session, and counterbalanced across participants. Each session consisted of testing with the ASG (Adaptive Situational Gain) feature on and off. The lower the number (dB level), the softer the participant is able to repeat the words correctly two out of three times.
Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
Time frame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Familiar monosyllabic word list presented at 40 dB and 70 dB. Percentage of words correctly repeated is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. The higher the score, the better the word recognition in each condition.
Multi-word Recognition at 40 dB SPL and 70 dB SPL
Time frame: Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)
Out of a list of seven words, the participant repeats back as many words as they can recall. Percentage of correct words repeated back is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. One fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. A higher percentage score indicates better multi-word recognition.
Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
Time frame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
A list of 10 3-word phrases are presented to the participant. The participant indicates if the phrase contains a nonsense word by selecting the numbered response button (i.e. "1", "2", or "3") that corresponds to the position oof the nonsense word in the phrase. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. . The score is the percent correct, a higher score is better.
Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
Time frame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
A word learning task used to determine participant's ability to associate novel/nonsense words with novel images as rapidly as possible. Five nonsense words are paired with five novel images displayed on response buttons. The words are presented randomly 10 times each. The participant selects one picture per word. Scores are presented as percent correct. A higher percentage indicates better word learning. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off.
Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
Time frame: 2nd appointment (day 14 of study)
Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.

Results and safety

Results posted to the registry on 19 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	16	14

Primary outcome: Speech Reception Threshold

Time frame: Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study). Mean (Standard Deviation). Unit: dB HL (decibels hearing level)

Measure	Experimental n = 15
NAL Fitting with ASG Off	27 (8)
NAL Fitting with ASG ON	27 (7)
DSL Fitting with ASG Off	24 (8)
DSL Fitting with ASG On	24 (6)

Experimental: p <0.05, Mixed Models Analysis
Experimental: p >0.05, Mixed Models Analysis

Population analysed: Participants who were fit with study hearing aids and completed at least one two-hour test session.

Primary outcome: Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.

Time frame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study). Mean (Standard Deviation). Unit: percentage of words correctly repeated

Measure	Experimental n = 15
% correct at 40 dB, NAL fitting, ASG Off	52 (24)
% correct at 40 dB, NAL fitting, ASG On	63 (26)
% correct at 40 dB, DSL fitting, ASG Off	69 (21)
% correct at 40 dB, DSL fitting, ASG On	75 (22)
% correct at 70 dB, NAL fitting, ASG Off	92 (10)
% correct at 70 dB, NAL fitting, ASG On	95 (5)
% correct at 70 dB, DSL fitting, ASG Off	95 (6)
% correct, DSL fitting, ASG On	96 (7)

Experimental: p <0.05, Mixed Models Analysis
Experimental: p <0.05, Mixed Models Analysis
Experimental: p <0.05, Mixed Models Analysis

Population analysed: Participants who were fit with study hearing aids and completed at least one two-hour test session.

Primary outcome: Multi-word Recognition at 40 dB SPL and 70 dB SPL

Time frame: Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study). Mean (Standard Deviation). Unit: percentage of words correctly repeated

Measure	Experimental n = 15
% correct at 40 dB for NAL fitting, ASG Off	48 (20)
% correct at 40 dB for NAL fitting, ASG On	56 (16)
% correct at 40 dB for DSL fitting, ASG Off	51 (16)
% correct at 40 dB for DSL fitting, ASG On	54 (16)
% correct at 70 dB, NAL fitting, ASG Off	66 (17)
% correct at 70 dB, NAL fitting, ASG On	67 (13)
% correct at 70 dB, DSL fitting, ASG Off	63 (13)
% correct at 70 dB, DSL fitting, ASG On	67 (13)

Experimental: p <0.05, Mixed Models Analysis
Experimental: p >0.05, Mixed Models Analysis
Experimental: p >0.05, Mixed Models Analysis

Population analysed: Participants who were fit with study hearing aids and completed at least one two-hour test session.

Primary outcome: Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.

Time frame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study). Mean (Standard Deviation). Unit: percentage of correct responses

Measure	Experimental n = 15
% correct at 40 dB, NAL fitting formula, ASG Off	65 (15)
% correct at 40 dB, NAL fitting with ASG On	68 (13)
% correct at 40 dB, DSL fitting, ASG Off	73 (18)
% correct at 40 dB, DSL fitting, ASG On	71 (12)
% correct at 70 dB, NAL fitting, ASG Off	89 (7)
% correct at 70 dB, NAL fitting, ASG On	87 (7)
% correct at 70 dB, DSL fitting, ASG Off	88 (9)
% correct at 70 dB, DSL fitting, ASG On	87 (7)

Experimental: p <0.05, Mixed Models Analysis
Experimental: p <0.05, Mixed Models Analysis
Experimental: p >0.05, Mixed Models Analysis

Population analysed: Participants who were fit with study hearing aids and completed at least one two-hour test session.

Adverse events

Time frame: 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Audeo hearing aid 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 19 May 2023. 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?

Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Reception Threshold (time frame: Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05150964.

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 19 May 2023.