ClinicalTrials.gg
RecruitingNCT06117254Updated Apr 20, 2026

Hearing Aids for Veterans With Functional Hearing Difficulties

An interventional study of Communication Counseling and Hearing Aids in Auditory Processing Disorder, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

Read the detailed description

At least 10% of Veterans seeking help in VA audiology clinics have clinically normal audiograms, a figure that broadly confirms a recent prevalence study indicating that 33.6% of current active-duty military Service Members are at risk of hearing and communication deficits despite having normal-hearing thresholds. While a considerable amount of research effort over the past 20 years has been devoted to understanding the potential causes for hearing difficulties in patients with normal hearing sensitivity, comparatively little research effort has been devoted to rehabilitation and improvement of function for these patients. This predicament has left audiologists and other medical professionals with very few evidence-based options to provide care for the large segment of help-seeking Veterans struggling with functional hearing difficulties. Currently, audiologic standard of care (SOC) for these patients involves reassurance of normal hearing and providing general communication tips, though evidence suggests that many patients are unsatisfied with this approach and request further testing and rehabilitation options. To help address patient concerns, many VA audiologists are now prescribing hearing aids though there is very little data on whether these devices improve functional outcomes for patients with self-reported hearing difficulties and normal hearing sensitivity. Therefore, the purpose of this study is to compare the efficacy of device-based rehabilitation options with current standard of care for Veterans with self-reported hearing and communication problems, and to identify subgroups in the sample that may benefit differently depending upon patient-specific characteristics and needs. The general hypothesis is that most Veterans with hearing difficulties and normal audiograms will benefit from device-based auditory rehabilitation as reflected by decreases in perceived hearing handicap. However, the amount of benefit will vary according to patient-specific characteristics including auditory, psychological and cognitive factors in combination with the type and severity of auditory dysfunction experienced by the patient.

All study participants will be Veterans with normal to near-normal pure-tone sensitivity but with moderate to severe perceived hearing handicap who are interested in seeking professional help. Participants will be interviewed to gather data regarding their hearing difficulties, including the context and impacts of difficulties as well as goals for auditory rehabilitation. Next, participants will undergo assessments of peripheral and central auditory system function including electrophysiological and behavioral measures and cognitive and psychological status assessed using established NIH Toolbox® measures. Participant medical charts will be reviewed to gather data on comorbid conditions and previous exposures known to be risk factors for developing auditory processing difficulties. These data will be compiled to provide an estimate of the distribution of characteristics likely to impact auditory function and response to intervention among Veterans seeking help for functional hearing difficulties. Participants will then be randomized into one of following three intervention arms: 1. SOC, 2. SOC + hearing aids, or 3. SOC + hearing aids with remote microphone. Outcomes will be measured at two- and six-months post-intervention. The primary outcome measure is the Hearing Handicap Inventory for Adults. Secondary outcome measures are aimed at identifying the underlying mechanisms and potential mediators that influence whether and how participants receive benefit from hearing devices. These will include measures of speech understanding in quiet and noise, objective and subjective listening effort, electrophysiological measures of neural responses to sound, and interviews to learn more about participants' perceptions of the intervention. Interaction effects will be estimated between treatment arm and patient characteristics to identify key moderating factors that influence the degree and direction of benefit associated with different treatment strategies. This information can then be used to inform both clinical decision making for individual patients and the design of future intervention studies.

02

Conditions studied

  • Auditory Processing Disorder

Keywords

  • Auditory Perception
  • Hearing
  • Acoustic Stimulation
03

In context

Auditory Perceptual Disorders

24 studies on the registry are indexed under Auditory Perceptual Disorders; 3 are open to participants now.

This study's planned enrollment of 142 is above the median of 52 across 18 interventional studies indexed under Auditory Perceptual Disorders.

Browse Auditory Perceptual Disorders studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
142 participants (estimated)

Study arms

  • Active comparator
    Communication Counseling

    Individuals 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.

    Behavioral: Communication Counseling

  • Experimental
    Hearing Aids

    Individuals randomized to this group will receive communication counseling as well as hearing aids set to provide a low level of amplification.

    Behavioral: Communication Counseling · Device: Hearing Aids

  • Experimental
    Hearing Aids with Remote Microphones

    Individuals 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.

    Behavioral: Communication Counseling · Device: Hearing Aids · Device: Remote Microphones

Interventions

  • BehavioralCommunication Counseling

    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.

  • DeviceHearing Aids

    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.

  • DeviceRemote Microphones

    Remote microphone systems will be provided for use with hearing aids.

06

What researchers measure

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.

    Time frame: Baseline and 2- and 6-months post randomization

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Oct 2027, 31 months after the start.

Of 12 interventional studies with no phase under Auditory Perceptual Disorders, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 62. This study's planned 31 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2023
First posted
Nov 3, 2023
StartActual
Mar 9, 2025
Primary completionEst.
Oct 29, 2027
CompletionEst.
Mar 31, 2028
Last update
Apr 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06117254
Responsible party
Sponsor
First posted
Nov 3, 2023
Start date
Mar 9, 2025
Primary completion
Oct 29, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Apr 20, 2026

Study contacts

Melissa A Papesh, PhD
Contact
Melissa.Papesh@va.gov
(503) 220-8262
Melissa A Papesh, PhD
principal investigator · VA Portland Health Care System, Portland, OR

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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