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Clinical Trials/NCT03345654
NCT03345654
Completed
N/A

Characterizing Variability in Hearing Aid Outcomes Among Older Adults

Northwestern University1 site in 1 country42 target enrollmentSeptember 8, 2023
ConditionsHearing Loss

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Northwestern University
Enrollment
42
Locations
1
Primary Endpoint
Speech intelligibility
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 8, 2023
End Date
November 8, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pamela Souza

Professor

Northwestern University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Speech intelligibility

Time Frame: Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later

Repeat low-context sentences

Secondary Outcomes

  • Post-fitting adjustment visits(First 30 days of fitting)
  • Speech and Spatial qualities questionnaire (SSQ)(Baseline at initial fit, then post intervention at final hearing aid appointment, about 30 days later)

Study Sites (1)

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