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Hearing Aids and the Brain

Hearing Aids and the Brain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03279510
Enrollment
20
Registered
2017-09-12
Start date
2018-03-22
Completion date
2021-01-31
Last updated
2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

auditory perception, hearing

Brief summary

Hearing aids are being fit on inexperienced hearing aid users and the short-term and long-term effects are measured. This research aims to improve understanding of the individual factors that contribute to receiving benefit from hearing aids and lead to more individualized treatment of hearing loss.

Detailed description

Hearing aids are used to improve audibility for patients with hearing loss and improve speech perception. In addition to these immediate benefits, amplification has the potential to have long-term effects on higher level auditory processing abilities, such as cognition or other abilities required for complex listening tasks. These long-term acclimatization effects are not well understood and merit further behavioral and physiological examination. Hearing aids will be fit on inexperienced hearing aid users and outcome measures will be used to determine immediate and long-term effects of hearing aids. This research may provide a more detailed view of individual differences that contribute to receiving benefit from a hearing aid and may lead to more individualized treatment of hearing loss.

Interventions

DEVICEhearing aids

Subjects are fit with hearing aids.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 50 years of age or older * Bilateral, mild to moderately severe hearing loss * Inexperienced hearing aid users

Exclusion criteria

* Subject deciding that they do not wish to wear hearing aids as necessitated per study protocol * Audiometric thresholds that suggest research stimuli would not be audible * Conductive hearing loss and/or other significant ear or hearing problems * Non-native English speakers * Conditions or circumstances that would preclude a participant from wearing hearing aids consistently or finishing the study * An inability to perform or complete the experimental tasks

Design outcomes

Primary

MeasureTime frameDescription
Evoked potential latencyApproximately 1 yearLatency will be measured in milliseconds
Evoked potential amplitudeApproximately 1 yearAmplitude will be measured in microvolts
Frequency following response magnitudeApproximately 1 yearMagnitude of response measured in nanovolts
Frequency following response timingApproximately 1 yearTiming measured by cross-correlation between stimulus and response
Ongoing electroencephalography powerApproximately 1 yearEEG power as a function of frequency recorded during words-in-noise measure
Montreal Cognitive Assessment scoreApproximately 1 yearAssessment score from 1 to 30
Reading SpanApproximately 1 yearPercent correct recall on working memory task
Hearing aid usageApproximately 1 yearData logging from the hearing aid will provide usage in hours per day
Word-in-noise perception testingApproximately 1 yearSignal-to-noise ratio at which participant correctly understands 50% of speech in noise using WIN test
Listening invested/required effortApproximately 1 yearParticipants' rating of the effort required (0-9) and invested (0-9) for listening task
Working memory testingApproximately 1 yearPerformance on auditory working memory task
Glasgow Hearing Aid Benefit Profile (GHABP)Approximately 1 yearParticipants rating on five-point scale their perceived initial (i.e., unaided) hearing disability, initial handicap, aided benefit, aided handicap, HA use and HA satisfaction in four listening situations

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026