NCT06962540

Brief Summary

The goal of this clinical trial is to learn if hearing aid settings that are customized to individual listening strategies result in better speech understanding than non-customized hearing aid settings. The main question it aims to answer is: Do customized hearing aid settings result in better speech understanding? Researchers will compare hearing aid settings that match individual listening strategy to a general setting. Participants will: Wear hearing aids for a 2-hour visit to our laboratory. Listen to some sentences in noise and repeat the sentences they hear, with two different hearing aid settings Listen to some sentences in noise and rate how understandable they think those sentences are, with two different hearing aid settings

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Apr 2025Jul 2027

First Submitted

Initial submission to the registry

December 2, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

April 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

December 2, 2024

Last Update Submit

April 28, 2026

Conditions

Keywords

Speech RecognitionHearing Aids

Outcome Measures

Primary Outcomes (1)

  • Speech recognition

    Participants listen to and repeat sentences, they are scored based on the % correct of keywords they accurately repeat.

    Outcome measure is collected during the intervention, a two hour visit to the lab where they are wearing the hearing aids

Secondary Outcomes (1)

  • Speech Spatial Quality

    Outcome measure is collected during the intervention, a two hour visit to the lab where they are wearing the hearing aids

Study Arms (2)

Customized to match listening strategy First

ACTIVE COMPARATOR

Participants in this arm will listen to hearing aid settings programmed to match their listening strategy first, then the general setting

Device: Hearing aid with settings customized to match their individual listening strategyDevice: Hearing Aid with settings based on audiogram alone

Not customized to match listening strategy First

ACTIVE COMPARATOR

Participants will listen to hearing aid settings based only on their pure-tone thresholds first (general hearing aid settings), then ones programmed to match their listening strategies.

Device: Hearing aid with settings customized to match their individual listening strategyDevice: Hearing Aid with settings based on audiogram alone

Interventions

Behind-the-ear hearing aids that have been programmed based on their hearing loss and typical clinical settings.

Also known as: General Hearing Aid Settings
Customized to match listening strategy FirstNot customized to match listening strategy First

Behind-the-ear hearing aids that have been programmed based on the participant's individual listening strategy and hearing loss.

Also known as: Customized Hearing Aid Settings
Customized to match listening strategy FirstNot customized to match listening strategy First

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sensorineural hearing loss

You may not qualify if:

  • Montreal Cognitive Assessment \< 23 points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

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

Study Officials

  • Pamela Souza, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know when they are listening to a hearing aid that is programmed with general or customizable settings.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will listen to hearing aids programmed specifically for their listening strategies or to ones programmed with typical clinical settings first, then switch strategies.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2024

First Posted

May 8, 2025

Study Start

April 18, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations