Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans

Conditions

• Auditory Diseases, Central

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• Phonak Lumina P90 — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Apr 1, 2024

Status verified

Apr 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

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.

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). ]

Central Contacts

• Jonathan Venezia, PhD
  (909) 825-7084
  [email protected]
• Akai R McKinley, BA
  (909) 825-7084
  [email protected]

Locations (3)

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