Individually-guided Hearing Aid Fitting

NCT ID: NCT03345654

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-08

Study Completion Date

2024-11-08

Brief Summary

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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

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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.

Conditions

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Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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New Hearing Aid Users fit with standard-of-care

Adults (18+) with hearing loss and newly fit with hearing aids

Hearing Aids

Intervention Type 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.

Interventions

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Hearing Aids

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.

Intervention Type OTHER

Other Intervention Names

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Hearing Aid Fitting

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Boulder

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Pamela Souza

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Evanston, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DC012289-06

Identifier Type: NIH

Identifier Source: org_study_id

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