Individually-guided Hearing Aid Fitting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Characterizing Variability in Hearing Aid Outcomes Among Older Adults

Conditions
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Hearing Loss

Intervention / Treatment
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* Other: Hearing Aids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New Hearing Aid Users fit with standard-of-care<br>Adults (18+) with hearing loss and newly fit with hearing aids | Other: Hearing Aids<br>* 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.<br>* Other names: Hearing Aid Fitting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech intelligibility | Repeat low-context sentences | Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-fitting adjustment visits | Number of times hearing aid adjustments are made post-fitting | First 30 days of fitting | 
| Speech and Spatial qualities questionnaire (SSQ) | Questionnaire evaluating subjective perception of hearing ability in different environments | Baseline at initial fit, then post intervention at final hearing aid appointment, about 30 days later |