Recruiting

Hearing AidsHearing Aids for Veterans With Functional Hearing Difficulties

Sponsor:

VA Office of Research and Development

Code:

NCT06117254

Conditions

Auditory Processing Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Communication Counseling

Hearing Aids

Remote Microphones

Study Details

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.

Conditions

Auditory Processing Disorder

Study ID

NCT06117254

Start date

Mar 9, 2025

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Oct 29, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

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.

Interventions

Communication 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.

Hearing 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.

Remote Microphones

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

Primary outcome measure

Change in Hearing Handicap Inventory for Adults (HHIA) score [ Time Frame: Baseline and 2- and 6-months post randomization ]

Central Contacts and Locations

Central contacts

Melissa A Papesh, PhD

(503) 220-8262 Melissa.Papesh@va.gov

Locations

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Danielle N Beaudry, MA

503-220-8262 danielle.beaudry@va.gov

Principal Investigator:

Melissa A Papesh, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

Auditory Perception
Hearing
Acoustic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-20.