Hearing LossNCT05893992
fNIRS, Listening Effort, and Motivation
A study testing Hearing aids with noise management features for listening in noise and Hearing aid for listening in quiet environments in people with Hearing Loss, run by Sonova AG at 1 site in Canada.
Trial summary
The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Participants will be instructed to listen to sentences in noise at a challenging signal-to-noise-ratio, and to repeat the word that they heard and rate how much subjective listening effort… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing aids with noise management features for listening in noise and Hearing aid for listening in quiet environments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 23 Sep 2023to 31 Dec 2024
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (18-99) years
- Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
- Fluent in English
Who cannot join
- Minors (17 years or less)
- Not able to tolerate wearing of hearing aids
- Vulnerable populations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impacts of Hearing Aid Use on Listening Effort and Motivation Using fNIRS
The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Participants will be instructed to listen to sentences in noise at a challenging signal-to-noise-ratio, and to repeat the word that they heard and rate how much subjective listening effort was required in order to make out the words. fNIRS will be measured throughout. Participants will complete the task using a hearing aid program intended for listening in quiet, and a hearing aid program with new advanced noise management features.
- Conditions
- Hearing Loss
- Being tested
- Hearing aids with noise management features for listening in noise, Hearing aid for listening in quiet environments
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aids with noise management features for listening in noiseDevice
Device for hearing loss compensation with digital noise management features
Hearing aid for listening in quiet environmentsDevice
Device for hearing loss compensation for listening in quiet environments
| Study group | Role | What they receive |
|---|---|---|
| Digital noise management, then quiet listening | Experimental | Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation with digital noise management features, followed by the device for hearing loss compensation for listening in quiet environments. Receives: Device: Hearing aids with noise management features for listening in noise; Device: Hearing aid for listening in quiet environments |
| Quiet listening, then digital noise management | Experimental | Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation for listening in quiet environments, followed by the device for hearing loss compensation with digital noise management features. Receives: Device: Hearing aids with noise management features for listening in noise; Device: Hearing aid for listening in quiet environments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS)
Infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. fNIRS in the prefrontal cortex is intended to index both motivation and listening effort.
Measured: Session 1, 2, 3 and 4; assessed for up to 2 hours
Secondary outcomes (2)
Listening Accuracy
Speech understanding in noise percent correct scores
Measured: Session 1, 2, 3 and 4; assessed for up to 2 hours
Subjective Listening Effort Rating
Participants rate how much listening effort was required in order to make out a sentence from 1-7, where lower scores mean less effort required.
Measured: Session 1, 2, 3 and 4; assessed for up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start23 Sep 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A single cohort of participants will receive and be assessed in all treatment/intervention
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Toronto Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Jinyu Qian, PhD, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893992
- Sponsor's protocol ID
- SRF-15557
- Status last verified
- May 2023
- First submitted
- 30 May 2023
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Hearing Aid Use on Listening Effort and Motivation Using fNIRS
- ClinicalTrials.gov ID
- NCT05893992
- Acronym / sponsor ID
- SRF-15557
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Toronto Metropolitan University
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Participants will be instructed to listen to sentences in noise at a challenging signal-to-noise-ratio, and to repeat the word that they heard and rate how much subjective listening effort was required in order to make out the words. fNIRS will be measured throughout. Participants will complete the task using a hearing aid program intended for listening in quiet, and a hearing aid program with new advanced noise management features.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single cohort of participants will receive and be assessed in all treatment/intervention
| Arm | Type | Receives |
|---|---|---|
| Digital noise management, then quiet listening | Experimental | Device: Hearing aids with noise management features for listening in noise, Device: Hearing aid for listening in quiet environmentsParticipants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation with digital noise management features, followed by the device for hearing loss compensation for listening in quiet environments. |
| Quiet listening, then digital noise management | Experimental | Device: Hearing aids with noise management features for listening in noise, Device: Hearing aid for listening in quiet environmentsParticipants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation for listening in quiet environments, followed by the device for hearing loss compensation with digital noise management features. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18-99) years
- Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
- Fluent in English
Key exclusion criteria (3 listed)
- Minors (17 years or less)
- Not able to tolerate wearing of hearing aids
- Vulnerable populations
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 |
|---|---|---|
| Hearing aids with noise management features for listening in noiseDevice for hearing loss compensation with digital noise management features | Device | Digital noise management, then quiet listening, Quiet listening, then digital noise management |
| Hearing aid for listening in quiet environmentsDevice for hearing loss compensation for listening in quiet environments | Device | Digital noise management, then quiet listening, Quiet listening, then digital noise management |
Primary outcome
Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS)
Time frame: Session 1, 2, 3 and 4; assessed for up to 2 hours
Infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. fNIRS in the prefrontal cortex is intended to index both motivation and listening effort.
2 secondary outcomes
Listening Accuracy
Time frame: Session 1, 2, 3 and 4; assessed for up to 2 hours
Subjective Listening Effort Rating
Time frame: Session 1, 2, 3 and 4; assessed for up to 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
Related trials for Hearing Loss
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Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
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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.
Jinyu Qian, PhD 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 Hearing aids with noise management features for listening in noise and Hearing aid for listening in quiet environments in people with Hearing Loss, run by Sonova AG at 1 site in Canada.
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 3 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 17 Aug 2025. 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 Canada. 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 17 Aug 2025). 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?
Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS) (time frame: Session 1, 2, 3 and 4; assessed for up to 2 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 17 Aug 2025.