Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06309264

Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans

Led by VA Office of Research and Development · Updated on 2026-04-14

80

Participants Needed

3

Research Sites

208 weeks

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

Since 2000, at least 250,000 U.S. Service members have experienced a blast-related mild traumatic brain injury. A retrospective analysis of over 100,000 post-9/11 Veterans shows that blast injury more than doubles the risk of a diagnosed auditory problem. Many blast-exposed Veterans experience "functional hearing difficulties" (FHDs): problems in challenging listening environments despite clinically normal hearing as measured by the pure-tone audiogram. VA audiologists have begun using low-gain hearing aids to treat FHDs, but there are no concrete guidelines for this application given standard procedures rely on the pure-tone audiogram. This study proposes a data-driven approach called speech-based audiometry (SBA), which optimizes hearing aid gains from a patient's responses to speech stimuli in aided conditions. This trial will assess the behavioral (speech recognition in noise, subjective listening difficulty) and neurophysiological (functional neuroimaging during a speech recognition task) benefits of low-gain hearing aids programmed conventionally or with SBA among blast-exposed Veterans with FHDs.

CONDITIONS

Official Title

Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female Veterans aged 18 to 60 years
  • Report at least one exposure to high-intensity blast close enough to feel heat or pressure
  • Score 20 or higher on the Hearing Handicap Inventory for Adults (HHIA)
  • Pure-tone average at 0.5, 1, 2, 4 kHz of 35 dB HL or better in each ear
  • Pure-tone thresholds no worse than 40 dB HL at any two frequencies up to 8 kHz
  • No more than 10 dB difference between ears at more than one frequency up to 4 kHz
  • Native speaker of English
  • Score of at least 25 on the Mini Mental State Exam
Not Eligible

You will not qualify if you...

  • Conductive hearing impairment or other ear pathology
  • Chronic disease or medications affecting hearing or ability to perform tasks
  • Inability to perform experimental tasks
  • Contraindications for MRI (e.g., pacemaker, metal clips, other metal devices)
  • Prior experience with hearing aids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

J

Jonathan Venezia, PhD

CONTACT

A

Akai R McKinley, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

2

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