Individually-guided Hearing Aid Fitting

• Conditions: Hearing Loss
• Interventions: Other: Hearing Aids

• Registration Number: NCT03345654
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Study Start: 2023-09-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
New Hearing Aid Users fit with standard-of-care	Hearing Aids	Adults (18+) with hearing loss and newly fit with hearing aids

Primary Outcome Measures

Name	Time	Method
Speech intelligibility	Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later	Repeat low-context sentences

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Evanston, Illinois, United States