Status:

COMPLETED

Individually-guided Hearing Aid Fitting

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

University of Colorado, Boulder

Conditions:

Hearing Loss

Eligibility:

All Genders

18-90 years

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 co...

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 audiolog...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 8 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 8 2024

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT03345654

Start Date

September 8 2023

End Date

November 8 2024

Last Update

May 2 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Northwestern University

Evanston, Illinois, United States, 60208

Individually-guided Hearing Aid Fitting | DecenTrialz