Recruiting

Hearing Aids

Sponsor:

VA Office of Research and Development

Code:

NCT06309264

Conditions

Auditory Diseases, Central

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Phonak Lumina P90

Study Details

Brief summary:

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

Auditory Diseases, Central

Study ID

NCT06309264

Start date

Apr 1, 2024

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

Human subjects will be male or female Veterans selected without regard to race or ethnic background. All subjects will be 18 years of age or older and no more than 60 years old. On the QCuBE, all subjects must report at least one exposure to high-intensity blast (e.g., RPG, IED, mortar) close enough to feel the heat or pressure of the blast wave. All subjects must also score 20 or higher on the Hearing Handicap Inventory for Adults (HHIA). The remaining inclusion criteria for all subjects are:

1. pure-tone average (PTA) at 0.5, 1, 2, 4 kHz of 35 dB HL or better in each ear;
2. pure-tone thresholds no worse than 40 dB HL at any two audiometric frequencies up to 8 kHz;
3. no differences in pure-tone thresholds exceeding 10 dB between the two ears at more than one audiometric frequency up to 4 kHz;
4. native speaker of English; and
5. a score of at least 25 on the Mini Mental State Exam.

Exclusion Criteria:

1. a conductive hearing impairment or other otological pathology;
2. chronic disease or use of medication that might affect the auditory system or the subject's ability to perform the experimental tasks;
3. an inability to perform the experimental tasks;
4. any contraindications for MRI scanning (this may specifically exclude subjects who have a pacemaker, metal clips, or any other metal device in their body, or who have any other contraindication for MRI as determined by an MRI screening questionnaire); and
5. experience with hearing aids prior to the study.

Potential subjects meeting criterion 4 (contraindications for fMRI) will remain eligible to complete the non-MRI components of the trial (all visits other than V3, V10). These will be included in a Intent to Treat (ITT) cohort. Additional subjects who are eligible for MRI will be recruited into a Per Protocol (PP) cohort until the PP cohort meets target for total sample size (N = 60).

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Speech-based hearing aid fitting

Half of the study participants receive a hearing aid with gain settings determined via speech-based audiometry. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.

active comparator: Audiogram-based hearing aid fitting

Half of the study participants receive a hearing aid with gain settings determined by applying the NAL-NL2 prescriptive formula to the pure-tone audiogram. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.

Interventions

Phonak Lumina P90

FDA approved hearing aid with gain settings determined either by speech-based audiometry or conventional fitting methods (NAL-NL2). Other features such as noise reduction and directional microphones are disabled for the duration of the study.

Primary outcome measure

  • Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks [ Time Frame: Assessed at baseline (pre-intervention; V4) and at the end of the final week of the 6-week hearing aid intervention (V11). Results will be reported through study completion, on average once per year (aligned with the RPPR). ]
  • Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Assessed at the end of the final week of the 6-week hearing aid intervention (V11). Results will be reported through study completion, on average once per year (aligned with the RPPR). ]

Central Contacts and Locations

Central contacts

Locations

VA Loma Linda Healthcare System, Loma Linda, CA

Recruiting

Loma Linda, California, United States, 92357-1000

Contacts

Principal Investigator:

Jonathan Venezia, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • blast injuries
  • occupational exposure
  • auditory diseases, central
  • hearing loss, hidden
  • hearing loss
  • hearing aids
  • hearing disorders
  • hearing loss, central
  • auditory perceptual disorders
  • correction of hearing impairment

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 2026-04-14.