Hearing Loss
Conditions
Brief 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.
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.
Interventions
OTHERHearing Aids
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.
Sponsors
University of Colorado, Boulder
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech intelligibility | Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later | Repeat low-context sentences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-fitting adjustment visits | First 30 days of fitting | Number of times hearing aid adjustments are made post-fitting |
| Speech and Spatial qualities questionnaire (SSQ) | Baseline at initial fit, then post intervention at final hearing aid appointment, about 30 days later | Questionnaire evaluating subjective perception of hearing ability in different environments |
Countries
United States
Outcome results
None listed