Hearing LossNCT03345654
Individually-guided Hearing Aid Fitting
An observational study of Hearing Loss, run by Northwestern University at 1 site in United States.
Trial summary
This translational project aims to optimize the fitting of hearing aids by development and clinical validation of a toolset that guides signal processing choice based on the individual auditory and cognitive abilities of the patient. 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?
- Hearing Aids
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 8 Nov 2024
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population will be recruited from the Northwestern University Center for Audiology, Speech, Learning, and Language. They will be adults (18+) who are new hearing aid users with no recent prior hearing aid experience. Any patient at the clinic who purchases a new pair of hearing aids and meets the study criteria will be provided information about the study.
Who may be able to join
- sensorineural hearing loss with pure-tone thresholds 70 dB HL or better at octave frequencies between 250 and 4000 Hz, 4 (.5, 1, 2, 3 kHz)
- frequency pure-tone average (PTA) of ≥ 30 dB HL.
- Listeners will have symmetrical losses, defined here as a 4-frequency PTA difference between ears ≤ 20 dB HL.
Who cannot join
- recent (within last 12 months) hearing aid use
- conductive loss (air-bone gaps > 10 dB at any frequency and/or abnormal immittance) -
- scoring < 23 on the Montreal Cognitive Assessment
- Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
- Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
- Significant history of otologic or neurologic disorders
Show all 9Show fewer
- Non English speaking participants
- Any clinically significant unstable or progressive medical condition
- Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing Variability in Hearing Aid Outcomes Among Older Adults
This translational project aims to optimize the fitting of hearing aids by development and clinical validation of a toolset that guides signal processing choice based on the individual auditory and cognitive abilities of the patient.
Read the detailed description
The clinical trial portion of the project will validate clinical use of the toolset by evaluating a population of patients fit using current standard of care. Patient characteristics, such as audiological profile and cognition, will be collected. Their hearing aid settings will then be evaluated to determine if they meet toolset guidelines for signal processing based on their patient characteristics (auditory and cognition). Data regarding subjective and objective hearing aid outcomes will also be collected. It is hypothesized that hearing aid fittings that meet the standards of the proposed clinical toolset will result in better patient outcomes (objective and subjective) and fewer post-fitting visits.
- Conditions
- Hearing Loss
- Being tested
- Hearing Aids
- 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 AidsOther
Also called Hearing Aid Fitting
The signal processing of newly fit hearing aids will be evaluated for acceptability based on the toolset, which takes additional patient information beyond hearing threshold (like cognition) to determine the optimal hearing aid signal processing strategies.
| Study group | Role | What they receive |
|---|---|---|
| New Hearing Aid Users fit with standard-of-care | Adults (18+) with hearing loss and newly fit with hearing aids Receives: Other: Hearing Aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intelligibility
Repeat low-context sentences
Measured: Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later
Secondary outcomes (2)
Post-fitting adjustment visits
Number of times hearing aid adjustments are made post-fitting
Measured: First 30 days of fitting
Speech and Spatial qualities questionnaire (SSQ)
Questionnaire evaluating subjective perception of hearing ability in different environments
Measured: Baseline at initial fit, then post intervention at final hearing aid appointment, about 30 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start8 Sep 2023
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Principal investigator, Pamela Souza, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345654
- Sponsor's protocol ID
- 1R01DC012289-06
- Status last verified
- Apr 2025
- First submitted
- 14 Nov 2017
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Variability in Hearing Aid Outcomes Among Older Adults
- ClinicalTrials.gov ID
- NCT03345654
- Acronym / sponsor ID
- 1R01DC012289-06
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 17 Nov 2017 (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.
This translational project aims to optimize the fitting of hearing aids by development and clinical validation of a toolset that guides signal processing choice based on the individual auditory and cognitive abilities of the patient.
Detailed description
The clinical trial portion of the project will validate clinical use of the toolset by evaluating a population of patients fit using current standard of care. Patient characteristics, such as audiological profile and cognition, will be collected. Their hearing aid settings will then be evaluated to determine if they meet toolset guidelines for signal processing based on their patient characteristics (auditory and cognition). Data regarding subjective and objective hearing aid outcomes will also be collected. It is hypothesized that hearing aid fittings that meet the standards of the proposed clinical toolset will result in better patient outcomes (objective and subjective) and fewer post-fitting visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Hearing Aid Users fit with standard-of-care | – | Other: Hearing AidsAdults (18+) with hearing loss and newly fit with hearing aids |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be recruited from the Northwestern University Center for Audiology, Speech, Learning, and Language. They will be adults (18+) who are new hearing aid users with no recent prior hearing aid experience. Any patient at the clinic who purchases a new pair of hearing aids and meets the study criteria will be provided information about the study.
Key inclusion criteria (3 listed)
- sensorineural hearing loss with pure-tone thresholds 70 dB HL or better at octave frequencies between 250 and 4000 Hz, 4 (.5, 1, 2, 3 kHz)
- frequency pure-tone average (PTA) of ≥ 30 dB HL.
- Listeners will have symmetrical losses, defined here as a 4-frequency PTA difference between ears ≤ 20 dB HL.
Key exclusion criteria (9 listed)
- recent (within last 12 months) hearing aid use
- conductive loss (air-bone gaps > 10 dB at any frequency and/or abnormal immittance) -
- scoring < 23 on the Montreal Cognitive Assessment
- Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
- Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
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 AidsAlso: Hearing Aid FittingThe signal processing of newly fit hearing aids will be evaluated for acceptability based on the toolset, which takes additional patient information beyond hearing threshold (like cognition) to determine the optimal hearing aid signal processing strategies. | Other | New Hearing Aid Users fit with standard-of-care |
Primary outcome
Speech intelligibility
Time frame: Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later
Repeat low-context sentences
2 secondary outcomes
Post-fitting adjustment visits
Time frame: First 30 days of fitting
Speech and Spatial qualities questionnaire (SSQ)
Time frame: Baseline at initial fit, then post intervention at final hearing aid appointment, about 30 days later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- 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.
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?
An observational study of Hearing Loss, 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 3 inclusion and 9 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 2 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later). 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 2 May 2025.