Hearing Aids for Veterans With Functional Hearing Difficulties
Evaluating Device-based Rehabilitation for Veterans With Functional Hearing Difficulties: A Randomized Controlled Trial
1 other identifier
interventional
142
1 country
1
Brief Summary
Every year, approximately 100,000 Veterans seek help at VA Audiology clinics for hearing and communication difficulties only to learn that they have normal hearing sensitivity. Unfortunately, there are very few established options to improve hearing and listening for these patients. To address this need, audiologists are increasingly prescribing hearing aids set to provide a small amount of amplification. Patients may benefit from the amplification or from modern hearing aid features such as noise reduction technology and the ability to stream sounds from a desired sound source directly to their ears thus reducing the background noise. This project will help to determine if prescribing hearing aids to patients without hearing loss is, in fact, beneficial and if so, why. It will also help to determine if some patients benefit more from hearing aids than others so that in the future, rehabilitation strategies can be better targeted toward individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedStudy Start
First participant enrolled
March 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
April 20, 2026
April 1, 2026
2.6 years
October 30, 2023
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hearing Handicap Inventory for Adults (HHIA) score
The HHIA is a self-report measure of the impact of hearing difficulties on daily life and functioning, including social and emotional affects. It is comprised of 25 questions with total scores from 0 to 100. Higher scores indicate greater levels of perceived hearing handicap.
Baseline and 2- and 6-months post randomization
Study Arms (3)
Communication Counseling
ACTIVE COMPARATORIndividuals randomized to this group will receive information on how to improve their ability to hear and communicate including tips on environmental modification and communication repair strategies.
Hearing Aids
EXPERIMENTALIndividuals randomized to this group will receive communication counseling as well as hearing aids set to provide a low level of amplification.
Hearing Aids with Remote Microphones
EXPERIMENTALIndividuals randomized to this group will receive communication counseling as well as hearing aids set to provide a low level of amplification and remote microphones that can be used in some situations to improve the signal-to-noise ratio.
Interventions
Individuals randomized to this group will receive information on how to improve their ability to hear and communicate including general tips on environmental modification and communication repair strategies and personalized tips to help with patient-specific listening difficulties. This is consistent with current audiological standard of care.
Hearing aids will be provided with amplification settings programmed specific to each participant's pure-tone hearing thresholds with subsequent adjustments based upon participant preferences. Standard noise cancelation and signal-to-noise ratio improvement strategies will be activated.
Remote microphone systems will be provided for use with hearing aids.
Eligibility Criteria
You may qualify if:
- Veteran eligible for VA Healthcare
- Ability to travel to VA Portland Medical Center for repeated visits
- Pure-tone thresholds of no more than 30 dB HL at frequencies between 500 and 3000 Hz, and no more than 40 dB HL at 4000 Hz
- HHIA scores of 24 or greater indicating moderate to significant perceived hearing handicap
You may not qualify if:
- Conductive hearing loss or other significant otologic problems
- Non-native English speakers
- Inability to perform experimental tasks
- Pure-tone interaural threshold asymmetries greater than 15 dB between 250 and 4000 Hz
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa A Papesh, PhD
VA Portland Health Care System, Portland, OR
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 3, 2023
Study Start
March 9, 2025
Primary Completion (Estimated)
October 29, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share