Hearing LossNCT04953390
Evaluating Benefits of Hearing Aid Microphone Directionality Technologies
A study testing Phonak Audeo hearing aid and Phonak hearing aid with multiple directionality settings, adjustable via a mobile app in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
This study will evaluate the impact of hearing aid microphone directionality technologies and settings on speech understanding in noise for experienced hearing aid users. It will also evaluate the participant's spatial awareness of sounds using these different hearing aid microphone directionality technologies. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Phonak Audeo hearing aid and Phonak hearing aid with multiple directionality settings, adjustable via a mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 2 Jul 2021
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- experienced hearing aid users
- moderate to moderate severe sensorineural symmetrical hearing loss defined as a difference of less than 10 dB between ears
- must be able to use app and smart phone
Who cannot join
- asymmetrical hearing losses
- unable or unwilling to use app and smart phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Benefits of Hearing Aid Microphone Directionality Technologies on Spatial Awareness and Speech Intelligibility
This study will evaluate the impact of hearing aid microphone directionality technologies and settings on speech understanding in noise for experienced hearing aid users. It will also evaluate the participant's spatial awareness of sounds using these different hearing aid microphone directionality technologies.
- Conditions
- Hearing Loss
- Being tested
- Phonak Audeo hearing aid, Phonak hearing aid with multiple directionality settings, adjustable via a mobile app
- 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
Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3
Phonak hearing aid with multiple directionality settings, adjustable via a mobile appDevice
Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period. Receives: Device: Phonak Audeo hearing aid; Device: Phonak hearing aid with multiple directionality settings, adjustable via a mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment
Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome.
Measured: Third appointment (day 28 of study)
Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment
Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome.
Measured: Third appointment (day 28 of study)
Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments
Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments. This is purely subjective and there is no better or worse answer.
Measured: Third appointment (day 28 of study)
Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments
Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments.
Measured: Third appointment (day 28 of study)
Secondary outcomes (3)
Speech Reception Threshold
Objective measure of speech reception thresholds with all three microphone settings (DIR1,DIR2,DIR3). This is calculated as the Signal to Noise Ratio at which participant can correctly repeat 50% of the words. A negative number (i.e. -10) indicates that the participant correctly repeated 50% of the words when the speech signal was softer or lower than the noise level. For example, an SNR score of -10 means that the the participant correctly repeated 50% of the words when the speech signal was 10 dB softer than the noise level. In this case, the noise level was appropriate to the microphone setting, i.e., DIR1 was tested in softer noise and DIR2 and DIR3 were tested in loud noise.
Measured: 2nd appointment (Day 14 of study)
Observations and Ratings of Satisfaction of Microphone Directionality in Real Life
Participants made adjustments of microphone directionality via an app, in real world listening situations. When participants adjusted the microphone directionality in real-time, they were also prompted via ecological momentary assessment to rate how satisfied they were with the adjustment. Participants chose one of three satisfaction ratings: no, slight, or clear. "Clear" satisfaction would be the best rating, indicating high satisfaction, "no" would be the worst rating, indicating no satisfaction, and "slight" would indicate somewhat satisfied.
Measured: 4 weeks
Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting
Participants listen to different samples of transition speed from one mic setting to another in an A/B comparison and rate which sample is more noticeable, i.e. A is more noticeable than B, A is less noticeable than B, or A and B are the same. No statistical analysis was done for this outcome measure. Frequency distribution was completed to record the number of responses in which participants rated a 0 second transition time more noticeable than a 2s, 4s, and 8s transition time.
Measured: Third appointment (day 28 of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start3 May 2021
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of participants will be evaluating different directional microphone settings on commercially available hearing aids
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Seitz-Paquette, AuD, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953390
- Sponsor's protocol ID
- SRF-369
- Status last verified
- Jul 2021
- First submitted
- 9 Jun 2021
- Last updated
- 9 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Benefits of Hearing Aid Microphone Directionality Technologies on Spatial Awareness and Speech Intelligibility
- ClinicalTrials.gov ID
- NCT04953390
- Acronym / sponsor ID
- SRF-369
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Posted 9 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the impact of hearing aid microphone directionality technologies and settings on speech understanding in noise for experienced hearing aid users. It will also evaluate the participant's spatial awareness of sounds using these different hearing aid microphone directionality technologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of participants will be evaluating different directional microphone settings on commercially available hearing aids
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Phonak Audeo hearing aid, Device: Phonak hearing aid with multiple directionality settings, adjustable via a mobile appAll study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- experienced hearing aid users
- moderate to moderate severe sensorineural symmetrical hearing loss defined as a difference of less than 10 dB between ears
- must be able to use app and smart phone
Key exclusion criteria (2 listed)
- asymmetrical hearing losses
- unable or unwilling to use app and smart phone
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 aidCommercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3 | Device | Experimental |
| Phonak hearing aid with multiple directionality settings, adjustable via a mobile appCommercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period. | Device | Experimental |
Primary outcome
Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment
Time frame: Third appointment (day 28 of study)
Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome.
Subjective Description of DIR1, DIR2, and DIR3 in Controlled Loud Noise Environment
Time frame: Third appointment (day 28 of study)
Participant describes an acoustically noisy environment in which recorded speech is played from a speaker directly in front of the participant and recorded multi-talker babble is played from multiple speakers around the participant. The participant uses a slider tool to choose if scene sounds acoustically wide (hearing all noise and speech), or acoustically narrow (hearing more of the speech than the noise). The range of the slider is 0-100, with 0 indicating the sound scene is "wide" and 100 indicating the sound scene is "narrow". The slider moves in 5 point increments. This is a purely subjective description and there is no better or worse outcome.
Subjective Preference DIR1, DIR2, and DIR3 in Controlled Soft Noise Environments
Time frame: Third appointment (day 28 of study)
Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments. This is purely subjective and there is no better or worse answer.
Subjective Preference DIR1, DIR2, and DIR3 in Controlled Loud Noise Environments
Time frame: Third appointment (day 28 of study)
Using a sliding scale, the participant chooses their preference for listening to the sound scene, however this time, 0 indicates "not preferred" and 100 indicates "most preferred". The slider moves in 5 point increments.
3 secondary outcomes
Speech Reception Threshold
Time frame: 2nd appointment (Day 14 of study)
Observations and Ratings of Satisfaction of Microphone Directionality in Real Life
Time frame: 4 weeks
Subjective Ratings of Transition Speed From One Directional Microphone Setting to Another Directional Setting
Time frame: Third appointment (day 28 of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kevin Seitz-Paquette, AuD principal investigator
Sonova AG
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 and Phonak hearing aid with multiple directionality settings, adjustable via a mobile app 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 4 inclusion and 2 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 9 Nov 2022. 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 9 Nov 2022). 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?
Subjective Description of DIR1, DIR2, and DIR3 in Controlled Soft Noise Environment (time frame: Third appointment (day 28 of study)). The study lists 4 primary outcomes in all. 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 9 Nov 2022.