NCT04521166

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 15, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

August 17, 2020

Results QC Date

June 26, 2024

Last Update Submit

September 11, 2025

Conditions

Keywords

hearing aidsdirectional microphonescognitioncompression

Outcome Measures

Primary Outcomes (1)

  • Speech Intelligibility (Percent Correct Scores)

    Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (\~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.

    ~20 mins for each intervention over the course of 1-2 days

Study Arms (4)

Setting 1

EXPERIMENTAL

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

Device: Hearing aid

Setting 2

EXPERIMENTAL

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

Device: Hearing aid

Setting 3

EXPERIMENTAL

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

Device: Hearing aid

Setting 4

EXPERIMENTAL

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

Device: Hearing aid

Interventions

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 1Setting 2Setting 3Setting 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> =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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Limitations and Caveats

Listeners were tested on the same day as the hearing aid fitting and were not provided with time to acclimate to the different settings. Experience with the different hearing aid settings could affect the role of working memory in speech understanding with hearing aids.

Results Point of Contact

Title
Varsha Rallapalli
Organization
Northwestern University

Study Officials

  • Varsha Rallapalli, AuD, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 20, 2020

Study Start

May 6, 2021

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

September 15, 2025

Results First Posted

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations