Hearing Aid Processing and Working Memory in Realistic Spatial Conditions

NCT ID: NCT04521166

Last Updated: 2025-09-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2023-06-29

Brief Summary

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The goal of this project is to determine whether the selection of hearing aid settings should be based in part on an individual's cognitive characteristics (specifically, working memory). We anticipate the outcomes of this study to be applicable to realistic listening conditions.

Detailed Description

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Hearing aids have specialized features to improve access to sounds for the hearing-impaired listener. The choice of appropriate hearing aid settings is integral to the hearing rehabilitative process. Researchers and clinicians have been influenced by previous work showing that individual cognitive abilities, including working memory, are associated with hearing aid benefit, especially in adverse listening conditions. However, previous research is limited to omnidirectional microphone settings and unrealistic listening conditions. Such conditions fail to recognize that most hearing aids are fit with directional processing that may improve the listening environment, and that typical environments contain speech and noise signals in a range of spatial locations. Therefore, the broad goal of this research is to understand how patient variables interact with hearing aid signal processing in realistic listening conditions in order to effectively treat hearing-impaired individuals in communications situations that are most important to them.

Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participant will be blinded to the hearing aid features being adjusted. The order of presentation of the hearing aid features will be randomized across participants, using a Latin-Square design. The outcomes assessor(s) (who score speech intelligibility) will also be blinded to the conditions.

Study Groups

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Setting 1

Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression

Group Type EXPERIMENTAL

Hearing aid

Intervention Type DEVICE

Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

Setting 2

Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression

Group Type EXPERIMENTAL

Hearing aid

Intervention Type DEVICE

Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

Setting 3

Hearing aid features presented in this arm include directional microphone settings and fast-acting compression

Group Type EXPERIMENTAL

Hearing aid

Intervention Type DEVICE

Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

Setting 4

Hearing aid features presented in this arm include directional microphone settings and slow-acting compression

Group Type EXPERIMENTAL

Hearing aid

Intervention Type DEVICE

Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

Interventions

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Hearing aid

Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \> =18 years of age; any sex
* Sensorineural hearing loss with pure-tone thresholds between 25-70 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz
* Speak English as their primary language
* Normal or corrected-to-normal vision (\<=20/50)
* Participants will be in good health (self-report)

Exclusion Criteria

* Clinically significant unstable or progressive medical conditions
* Participants who score \< 23 on the cognitive screening test (Montreal Cognitive Assessment)
* Evidence of conductive hearing loss or middle ear issues
* Significant history of otologic or neurologic disorders
* Evidence of significant asymmetry between ears
* Non-English-speaking or non-native English speaking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Pamela Souza

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Varsha Rallapalli, AuD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Evanston, Illinois, United States

Site Status

Countries

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United States

References

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Rallapalli V, Freyman R, Souza P. Relationship Between Working Memory, Compression, and Beamformers in Ideal Conditions. Ear Hear. 2025 Mar-Apr 01;46(2):523-536. doi: 10.1097/AUD.0000000000001605. Epub 2024 Nov 6.

Reference Type DERIVED
PMID: 39620655 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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K01DC018324

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00210459

Identifier Type: -

Identifier Source: org_study_id

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