Characterizing Variability in Hearing Aid Outcomes Among Older Adults
| Registry | NCT03345654 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 42 (Actual) |
| Sponsor | Northwestern University (Other); collaborators: University of Colorado, Boulder |
| Conditions | Hearing Loss |
| Interventions | Hearing Aids (Other) |
| Dates | start 2023-09-08, primary completion 2024-11-08, completion 2024-11-08, first posted 2017-11-17, last updated 2025-05-02 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Hearing Loss All trials of Hearing Aids
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| New Hearing Aid Users fit with standard-of-care | Other: Hearing Aids | Adults (18+) with hearing loss and newly fit with hearing aids |
Sex: All, ages: 18 Years to 90 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Northwestern University | Evanston, Illinois | United States |