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Completed

NCT Number: NCT03345654

Individually-guided Hearing Aid Fitting

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Evanston, Illinois, 60208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hearing Aids

Other

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.

Other names: Hearing Aid Fitting

Primary outcomes

  1. 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

  1. Post-fitting adjustment visits

    Time frame: First 30 days of fitting

    Number of times hearing aid adjustments are made post-fitting

  2. Speech and Spatial qualities questionnaire (SSQ)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • University of Colorado, Boulder

Registry information

Official study title

Characterizing Variability in Hearing Aid Outcomes Among Older Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2017
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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