Hearing Aids and the Brain

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: hearing aids

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System, Portland, OR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hearing aids; All study participants will be fit with hearing aids.	Device: hearing aids; Subjects are fit with hearing aids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evoked potential latency	Latency will be measured in milliseconds	Approximately 1 year
Evoked potential amplitude	Amplitude will be measured in microvolts	Approximately 1 year
Frequency following response magnitude	Magnitude of response measured in nanovolts	Approximately 1 year
Frequency following response timing	Timing measured by cross-correlation between stimulus and response	Approximately 1 year
Ongoing electroencephalography power	EEG power as a function of frequency recorded during words-in-noise measure	Approximately 1 year
Montreal Cognitive Assessment score	Assessment score from 1 to 30	Approximately 1 year
Reading Span	Percent correct recall on working memory task	Approximately 1 year
Hearing aid usage	Data logging from the hearing aid will provide usage in hours per day	Approximately 1 year
Word-in-noise perception testing	Signal-to-noise ratio at which participant correctly understands 50% of speech in noise using WIN test	Approximately 1 year
Listening invested/required effort	Participants' rating of the effort required (0-9) and invested (0-9) for listening task	Approximately 1 year
Working memory testing	Performance on auditory working memory task	Approximately 1 year
Glasgow Hearing Aid Benefit Profile (GHABP)	Participants 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	Approximately 1 year

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: hearing; auditory perception
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: C2396-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No