Hearing Loss, SensorineuralDIRWDRCWMNCT04521166
Hearing Aid Processing and Working Memory in Realistic Spatial Conditions
A study testing Hearing aid in people with Hearing Loss, Sensorineural, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this project is to determine whether the selection of hearing aid settings should be based in part on an individual's cognitive characteristics (specifically, working memory). We anticipate the outcomes of this study to be applicable to realistic listening conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 29 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > =18 years of age; any sex
- Sensorineural hearing loss with pure-tone thresholds between 25-70 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz
- Speak English as their primary language
- Normal or corrected-to-normal vision (<=20/50)
- Participants will be in good health (self-report)
Who cannot join
- Clinically significant unstable or progressive medical conditions
- Participants who score < 23 on the cognitive screening test (Montreal Cognitive Assessment)
- Evidence of conductive hearing loss or middle ear issues
- Significant history of otologic or neurologic disorders
- Evidence of significant asymmetry between ears
- Non-English-speaking or non-native English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Relationship Between Directional Microphones, Compression, and Working Memory in Realistic Spatial Conditions.
The goal of this project is to determine whether the selection of hearing aid settings should be based in part on an individual's cognitive characteristics (specifically, working memory). We anticipate the outcomes of this study to be applicable to realistic listening conditions.
Read the detailed description
Hearing aids have specialized features to improve access to sounds for the hearing-impaired listener. The choice of appropriate hearing aid settings is integral to the hearing rehabilitative process. Researchers and clinicians have been influenced by previous work showing that individual cognitive abilities, including working memory, are associated with hearing aid benefit, especially in adverse listening conditions. However, previous research is limited to omnidirectional microphone settings and unrealistic listening conditions. Such conditions fail to recognize that most hearing aids are fit with directional processing that may improve the listening environment, and that typical environments contain speech and noise signals in a range of spatial locations. Therefore, the broad goal of this research is to understand how patient variables interact with hearing aid signal processing in realistic listening conditions in order to effectively treat hearing-impaired individuals in communications situations that are most important to them.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Hearing aid
- Keywords
- hearing aids, directional microphones, cognition, compression
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aidDevice
Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.
| Study group | Role | What they receive |
|---|---|---|
| Setting 1 | Experimental | Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression Receives: Device: Hearing aid |
| Setting 2 | Experimental | Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression Receives: Device: Hearing aid |
| Setting 3 | Experimental | Hearing aid features presented in this arm include directional microphone settings and fast-acting compression Receives: Device: Hearing aid |
| Setting 4 | Experimental | Hearing aid features presented in this arm include directional microphone settings and slow-acting compression Receives: Device: Hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility (Percent Correct Scores)
Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.
Measured: ~20 mins for each intervention over the course of 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start6 May 2021
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Factorial
- Model description
- Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Pamela Souza, Northwestern University
- Investigators
- Varsha Rallapalli, AuD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521166
- Sponsor's protocol ID
- STU00210459
- Other IDs
- K01DC018324
- Acronym
- DIRWDRCWM
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2020
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rallapalli V, Freyman R, Souza P. Relationship Between Working Memory, Compression, and Beamformers in Ideal Conditions. Ear Hear. 2025 Mar-Apr 01;46(2):523-536. doi: 10.1097/AUD.0000000000001605. Epub 2024 Nov 6.
PubMed 39620655
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Directional Microphones, Compression, and Working Memory in Realistic Spatial Conditions.
- ClinicalTrials.gov ID
- NCT04521166
- Acronym / sponsor ID
- DIRWDRCWM / STU00210459
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- hearing aids, directional microphones, cognition, compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to determine whether the selection of hearing aid settings should be based in part on an individual's cognitive characteristics (specifically, working memory). We anticipate the outcomes of this study to be applicable to realistic listening conditions.
Detailed description
Hearing aids have specialized features to improve access to sounds for the hearing-impaired listener. The choice of appropriate hearing aid settings is integral to the hearing rehabilitative process. Researchers and clinicians have been influenced by previous work showing that individual cognitive abilities, including working memory, are associated with hearing aid benefit, especially in adverse listening conditions. However, previous research is limited to omnidirectional microphone settings and unrealistic listening conditions. Such conditions fail to recognize that most hearing aids are fit with directional processing that may improve the listening environment, and that typical environments contain speech and noise signals in a range of spatial locations. Therefore, the broad goal of this research is to understand how patient variables interact with hearing aid signal processing in realistic listening conditions in order to effectively treat hearing-impaired individuals in communications situations that are most important to them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.
| Arm | Type | Receives |
|---|---|---|
| Setting 1 | Experimental | Device: Hearing aidHearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression |
| Setting 2 | Experimental | Device: Hearing aidHearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression |
| Setting 3 | Experimental | Device: Hearing aidHearing aid features presented in this arm include directional microphone settings and fast-acting compression |
| Setting 4 | Experimental | Device: Hearing aidHearing aid features presented in this arm include directional microphone settings and slow-acting compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > =18 years of age; any sex
- Sensorineural hearing loss with pure-tone thresholds between 25-70 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz
- Speak English as their primary language
- Normal or corrected-to-normal vision (<=20/50)
- Participants will be in good health (self-report)
Key exclusion criteria (6 listed)
- Clinically significant unstable or progressive medical conditions
- Participants who score < 23 on the cognitive screening test (Montreal Cognitive Assessment)
- Evidence of conductive hearing loss or middle ear issues
- Significant history of otologic or neurologic disorders
- Evidence of significant asymmetry between ears
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 aidSettings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality. | Device | Setting 1, Setting 2, Setting 3, Setting 4 |
Primary outcome
Speech Intelligibility (Percent Correct Scores)
Time frame: ~20 mins for each intervention over the course of 1-2 days
Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39620655Rallapalli V, Freyman R, Souza P. Relationship Between Working Memory, Compression, and Beamformers in Ideal Conditions. Ear Hear. 2025 Mar-Apr 01;46(2):523-536. doi: 10.1097/AUD.0000000000001605. Epub 2024 Nov 6.
- 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.
Varsha Rallapalli, AuD, PhD principal investigator
Northwestern University
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 aid in people with Hearing Loss, Sensorineural, run by Northwestern University 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 5 inclusion and 6 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 15 Sep 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 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 15 Sep 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?
Speech Intelligibility (Percent Correct Scores) (time frame: ~20 mins for each intervention over the course of 1-2 days). 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 NCT04521166, which also lists 1 linked publication.
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 15 Sep 2025.