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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1
Northwestern University
Evanston, Illinois, United States, 60208