Hearing Aids for Veterans With Functional Hearing Difficulties

Part of paid clinical trials in Portland, Oregon.

Sponsor
VA Office of Research and Development
Study ID
NCT06117254
Status
Recruiting

Conditions

  • Auditory Processing Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Communication Counseling — BEHAVIORAL
    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 — DEVICE
    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 — DEVICE
    Remote microphone systems will be provided for use with hearing aids.

Study Details

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.

Key Dates

Start date
Mar 9, 2025
Status verified
Apr 2026
Primary completion
Oct 29, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Danielle N Beaudry, MA
503-220-8262
Melissa A Papesh, PhD (PRINCIPAL_INVESTIGATOR)

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