Actively Recruiting
Benefits of Speech-based Audiometry and Low-gain Hearing Aids for Blast-exposed Veterans
Led by VA Office of Research and Development ยท Updated on 2026-04-14
80
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
U
University of California, San Diego
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate low-gain hearing aids programmed using either conventional audiogram-based methods or a new speech-based audiometry (SBA) approach in blast-exposed Veterans experiencing functional hearing difficulties (FHDs) despite normal or near-normal hearing. Blast injury has been linked to increased risk of auditory problems, and this study focuses on improving hearing aid fitting to better address speech recognition and listening challenges in this population. Participants will be randomly assigned to receive hearing aids programmed with either the SBA method or standard audiogram-based settings. Each group is further divided into subgroups where some use their hearing aids daily over six weeks, while others use them only for outcome testing. The study includes prescreening, preparatory visits for fitting and verification, a baseline period with assessments including fMRI and speech-in-noise tests, a five-week treatment period with weekly monitoring, and a follow-up period with repeated assessments. Throughout the study, participants will undergo a series of evaluations including audiological exams, questionnaires on hearing difficulties and cognitive function, speech recognition tests, and brain imaging during speech tasks. Hearing aid performance and usage are closely monitored with specialized equipment and data logging. Primary outcomes include changes in speech-in-noise test scores and subjective hearing aid benefit measured before and after the six-week intervention. Safety and hearing aid function are regularly checked during weekly visits, with study completion followed by transition back to routine care.
CONDITIONS
Brief Title
Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female Veterans aged 18 to 60 years
- At least one exposure to high-intensity blast close enough to feel heat or pressure
- Score of 20 or higher on the Hearing Handicap Inventory for Adults (HHIA)
- Pure-tone average hearing level of 35 dB HL or better in each ear
- Pure-tone thresholds no worse than 40 dB HL at any two audiometric frequencies up to 8 kHz
- No differences in pure-tone thresholds exceeding 10 dB between ears at more than one frequency up to 4 kHz
- Native English speaker
- Score of at least 25 on the Mini Mental State Exam (MMSE)
You will not qualify if you...
- Conductive hearing impairment or other ear pathology
- Chronic disease or medication affecting auditory system or ability to perform tasks
- Inability to perform experimental tasks
- Contraindications for MRI scanning (e.g., pacemaker, metal clips, or other metal devices)
- Prior experience with hearing aids
- Subjects with MRI contraindications may still participate in non-MRI parts of the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Approximately 2 weeks
Participants complete two visits to prepare for the hearing aid intervention, including speech-based audiometry or conventional fitting, real ear measurements, hearing aid programming, and counseling.
2 visits (in-person)
Duration - Up to 1 week
Participants complete baseline assessments including an initial fMRI scan and speech-in-noise evaluations before starting hearing aid use.
2 visits (in-person)
Duration - 6 weeks
Participants use hearing aids programmed by either speech-based audiometry or conventional methods. Weekly visits occur to verify hearing aid gain settings, check usage data, and complete speech-in-noise testing during the first five weeks of the six-week intervention.
5 weekly visits (in-person)
Duration - 1 week
In the final week, participants complete two visits including a second fMRI scan, speech-in-noise testing, questionnaires on hearing aid benefit, and final assessments before transitioning back to routine care.
2 visits (in-person)
Trial Site Locations
Total: 3 locations
1
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357-1000
Actively Recruiting
2
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343
Not Yet Recruiting
3
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003
Not Yet Recruiting
Research Team
J
Jonathan Venezia, PhD
A
Akai R McKinley, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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