Auditory Processing DisorderNCT06117254
Hearing Aids for Veterans With Functional Hearing Difficulties
A study testing Communication Counseling, Hearing Aids and Remote Microphones in people with Auditory Processing Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Auditory Processing Disorder
- What is being tested?
- Communication Counseling, Hearing Aids and Remote Microphones
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
Danielle N Beaudry, MA, 503-220-8262 ext. 57524, danielle.beaudry@va.gov
Melissa A Papesh, PhD
About this study
Official title: Evaluating Device-based Rehabilitation for Veterans With Functional Hearing Difficulties: A Randomized Controlled Trial
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.
- Conditions
- Auditory Processing Disorder
- Being tested
- Communication Counseling, Hearing Aids, Remote Microphones
- Keywords
- Auditory Perception, Hearing, Acoustic Stimulation
- Medical subject headings
- Auditory Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication CounselingBehavioural
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 AidsDevice
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 MicrophonesDevice
Remote microphone systems will be provided for use with hearing aids.
| Study group | Role | What they receive |
|---|---|---|
| Communication Counseling | Active comparator | 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. Receives: Behavioral: Communication Counseling |
| Hearing Aids | Experimental | Individuals randomized to this group will receive communication counseling as well as hearing aids set to provide a low level of amplification. Receives: Behavioral: Communication Counseling; Device: Hearing Aids |
| Hearing Aids with Remote Microphones | Experimental | 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. Receives: Behavioral: Communication Counseling; Device: Hearing Aids; Device: Remote Microphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2- and 6-months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start9 Mar 2025
- Primary completion29 Oct 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Processing DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Melissa A Papesh, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117254
- Sponsor's protocol ID
- C4791-R
- Status last verified
- Apr 2026
- First submitted
- 30 Oct 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Device-based Rehabilitation for Veterans With Functional Hearing Difficulties: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06117254
- Acronym / sponsor ID
- C4791-R
- Conditions
- Auditory Processing Disorder
- Keywords
- Auditory Perception, Hearing, Acoustic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Mar 2025 (actual)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Communication Counseling | Active comparator | Behavioral: Communication CounselingIndividuals 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 | Experimental | Behavioral: Communication Counseling, Device: Hearing AidsIndividuals 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 | Experimental | Behavioral: Communication Counseling, Device: Hearing Aids, Device: Remote MicrophonesIndividuals 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication CounselingIndividuals 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. | Behavioural | Communication Counseling, Hearing Aids, Hearing Aids with Remote Microphones |
| Hearing AidsHearing 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. | Device | Hearing Aids, Hearing Aids with Remote Microphones |
| Remote MicrophonesRemote microphone systems will be provided for use with hearing aids. | Device | Hearing Aids with Remote Microphones |
Primary outcome
Change in Hearing Handicap Inventory for Adults (HHIA) score
Time frame: Baseline and 2- and 6-months post randomization
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa A Papesh, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Counseling, Hearing Aids and Remote Microphones in people with Auditory Processing Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa A Papesh, PhD ((503) 220-8262, Melissa.Papesh@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hearing Handicap Inventory for Adults (HHIA) score (time frame: Baseline and 2- and 6-months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.