New hearing aid method could help veterans who 'Hear but Can't Understand'
NCT ID NCT06309264
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
Many blast-exposed veterans struggle to hear in noisy places even though their standard hearing tests are normal. This study tests whether a new fitting method called speech-based audiometry (SBA) makes low-gain hearing aids more effective than the usual approach. Eighty veterans will use Phonak Lumina P90 hearing aids programmed either with SBA or conventional settings, and researchers will measure improvements in speech understanding and listening effort over six weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Phonak Lumina P90 hearing aid
- What this could lead to
- If successful, this could provide a new, data-driven way to fit hearing aids for veterans with hidden hearing problems, improving their ability to understand speech in noisy places.
- What could go wrong
- This is a small, early-stage study (80 participants) focused on a specific group (blast-exposed veterans). The benefits may not apply to others, and the hearing aids may not work better than standard fitting methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VA Greater Los Angeles Healthcare System, Sepulveda, CA
NOT_YET_RECRUITINGSepulveda, California, 91343, United States
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VA Greater Los Angeles Healthcare System, West Los Angeles, CA
NOT_YET_RECRUITINGWest Los Angeles, California, 90073-1003, United States
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VA Loma Linda Healthcare System, Loma Linda, CA
RECRUITINGLoma Linda, California, 92357-1000, United States