Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans
This study is looking at how different ways of setting up hearing aids can help Veterans who have experienced blast injuries and have trouble hearing in noisy places, even if their regular hearing tests are normal. We are comparing two methods for programming the Phonak Lumina P90 hearing aid: a standard method (NAL-NL2) and a new method called speech-based audiometry. The main goal is to see if one method helps Veterans understand speech better in noise and improves their overall hearing aid benefit after 6 weeks. We are enrolling 80 Veterans aged 18 to 60 who have experienced a blast and have these "functional hearing difficulties."
- Study design
- This is an interventional, randomized study involving 80 participants. Participants will be assigned to different groups to receive hearing aids programmed with either conventional or speech-based methods.
- What's involved
- You will participate in a 6-week intervention period, completing several assessments before, during, and after this time. Some participants will use their hearing aid daily, while others will only use it for assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be assessed at the end of the 6-week hearing aid intervention period.
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Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans
At a glance
Conditions
Where it's being run
3 sites across 1 statesStudy leadership
- Jonathan Venezia, PhD · PRINCIPAL_INVESTIGATOR · VA Loma Linda Healthcare System, Loma Linda, CA
Who to contact
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What this trial measures
- Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeksAssessed 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).
Participants repeat back sentences embedded in four-talker babble, with each sentence presented at one of six signal-to-noise ratios decreasing from 33.5 dB to 8.5 dB in 5 dB steps. Each sentence is scored for number of correct keywords (out of five) and the total number correct over six sentences is subtracted by a normative value of 25.5 to obtain the "signal-to-noise ratio loss." The average signal-to-noise ratio loss across two sets of six sentences is obtained. The target sentences are time-compressed by 66% and subject to simulated room reverberation (0.25 s reverberation time). The outcome is the aided vs. unaided difference across all measurement time points (within-subject). The effect of hearing aid fitting method (conventional, speech-based) is obtained between-subjects. The effect of hearing aid acclimatization is the between-subject difference (daily use group vs. no daily use group) in the change of the aided vs. unaided difference at 6 weeks.
- Abbreviated Profile of Hearing Aid Benefit (APHAB)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).
The APHAB is a validated questionnaire that measures subjective levels of listening difficulty pre and post hearing aid fitting in persons with hearing loss. The APHAB has been used to quantify subjective benefits of low-gain hearing aids in Service members with FHDs. The APHAB will be completed at the end of the study by participants assigned to use their hearing aids daily. The primary subjective study outcome is the aided vs. unaided difference in APHAB global score, obtained within-subject at a single time point (end of the final week of the six-week acclimatization period). The effect of hearing aid fitting method (conventional, speech-based) is obtained between-subjects.