Individually-guided Hearing Aid Fitting

Northwestern University42 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hearing Loss

Interventions

Hearing AidsOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Northwestern University

Evanston, Illinois, United States

Outcomes

Primary Outcomes

Speech intelligibility

Repeat low-context sentences

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

Secondary Outcomes

Post-fitting adjustment visits

Number of times hearing aid adjustments are made post-fitting

Time frame: First 30 days of fitting

Speech and Spatial qualities questionnaire (SSQ)

Questionnaire evaluating subjective perception of hearing ability in different environments

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

Data from ClinicalTrials.gov

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