N/A
N=320
Wide Frequency Band Test of Hearing in Veterans
Hearing Loss, Sensorineural · Hearing Loss, Conductive · Hearing Loss, Mixed Conductive-Sensorineural · Otosclerosis · Tympanic Membrane Perforation
Bottom Line
View on ClinicalTrials.gov: NCT02019888 ↗Enrolled (actual)
320
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Experimental Middle Ear Test: Ambient Wideband Absorbance — 0.39; 0.38; 0.32 Ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Experimental Middle Ear Test: Ambient Wideband Absorbance |
0.39; 0.38; 0.32 | — |
| SECONDARY Middle Ear Muscle Reflex Test |
85.45; 92.02; 94.36; 69.54; 86.99; 93.27 | — |
| SECONDARY Wideband Otoacoustic Emission Test |
10.29; 4.29; 3.30 | — |
| SECONDARY Clinical Middle Ear Test: Peak Static Acoustic Admittance |
0.7; 0.8; 0.81 | — |
Summary
The accurate assessment of auditory status is critical for planning treatment for Veterans with hearing loss to include medical and audiological management. Current physiologic tests of auditory function in the standard clinical audiological test battery for Veterans have limited sensitivity in detecting some middle-ear disorders, and do not include a direct test of cochlear function. Recent studies have shown promise for new wide-bandwidth (WB) tests of absorbance for improved sensitivity in the assessment of middle-ear function including acoustic reflex testing. The addition of WB tests of cochlear function included in the WB test battery provides an opportunity to improve audiological diagnosis of a range of hearing disorders in Veterans. The automation provided by the WB test battery could provide additional benefits in reducing the duration of the evaluation, leaving more time for evaluation of test findings and counseling. Results from this study may lead to the improvement of audiological care for Veterans with hearing loss.
Eligibility Criteria
Inclusion Criteria
Adults with normal hearing
- Veteran status
- Age between 20 and 79 years
- All puretone thresholds at 25 dB HL or lower
Adults with sensory neural hearing loss
- Veteran status
- Age between 20 and 79 years
- Average hearing thresholds between 26 and 55 dB HL
Adults with middle ear disorders
- Veteran status
- Adult between 20 and 89 years
- Diagnosis of middle ear disorder
Exclusion Criteria
- Draining ear
- Sensory neural hearing loss greater than 55 dB HL
- Cerumen impaction of ear canal
Data sourced from ClinicalTrials.gov (NCT02019888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.