Comprehensive Wide Bandwidth Test Battery of Auditory Function in Veterans
Conditions: Hearing Loss, Sensorineural, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Otosclerosis, Tympanic Membrane Perforation, Otitis Media With Effusion, Cholesteatoma
Sponsor: VA Office of Research and Development

Official Title: 
Comprehensive Wide Bandwidth Test Battery of Auditory Function 
in Veterans 
 
NCT Number: 
02019888 
 
Document Date: 
3/5/2021 
 

Study Protocol 
The goal of this research is to evaluate a comprehensive test battery of new wide-
bandwidth, i.e., wideband (WB), acoustical tests of auditory function in the differential 
diagnosis of middle ear, cochlear and neural pathologies in a population of Veterans. 
WB tests refer to ear canal tests using sound responses measured from 200 Hz to 
frequencies as high as 8000 Hz, a bandwidth that is critical for speech perception. 
There will be tests in the battery for middle-ear assessment using absorbance cochlear 
assessment using otoacoustic emissions (OAEs) and the acoustic stapedius reflex 
(ASR) using middle ear power absorption. Results will be compared with a standard 
single-frequency clinical immittance test battery routinely used in the assessment of 
auditory function in Veterans.  
Aim 1 seeks to evaluate the accuracy of the WB test battery in the differential diagnosis 
of middle-ear pathology and related conductive hearing loss by comparing the 
sensitivity and specificity of the WB battery to the traditional immittance battery for 
disorders common in Veterans including tympanic membrane perforation and serous 
otitis media.  Aim 2 seeks to modify a WB ASR test to provide automatic detection of 
the ASR threshold for comparison with the traditional single-frequency ASR threshold.  
Aim 3 seeks to validate the use of Transient-evoked otoacoustic emission (TEOAE) and 
spontaneous otoacoustic emissions (SOAEs) tests in Veterans to assess cochlear 
status, and evaluate their test performance in classifying ears with normal hearing and 
sensorineural hearing loss.  The combination of tests across aims will allow for 
examination of the diagnostic accuracy of the full WB test battery in comparison tot he 
single-frequency admittance test battery to detect any type of hearing loss including 
sensorineural, conductive and mixed. The hypothesis is that the WB test battery is more 
accurate than the traditional immittance test battery in identifying ears with normal 
auditory status and ears with a range of risks for auditory pathology. 
Methods: 
Subjects- Human subjects will be recruited for this study who have had a hearing 
evaluation from the VA Audiology Service at the Portland VA Medical Center and the H. 
Quillen VA Medical Center. These subjects will respond to flyers or be contacted from 
an IRB-approved human subject volunteer registry. Data will be acquired from three 
groups of subjects with normal hearing, sensorineural hearing loss (SNHL), and middle 
ear disorders.   
Testing- All subjects will receive the same clinical and WB test battery. Each subject will 
be tested in one laboratory visit. Subjects will be enrolled in this study that upon 
otoscopic inspection of their ear canals, have no active drainage from the ears, and 
have ear canals free of cerumen (wax) impaction, bilaterally. Subjects who are found to 
have draining ears or cerumen impaction will be referred for treatment. These 
individuals may be enrolled in the study following successful treatment for their 
conditions. All subjects will have a standard pure-tone air- and bone-conduction 

audiogram while comfortably seated in a sound-treated booth. Standard insert 
earphones and a bone-conduction vibrator will be used to present the sound stimuli. 
Next, speech audiometry will be completed and the speech reception thresholds, 
uncomfortable loudness test for speech, and speech recognition scores will be 
obtained. Then the subjects will have a standard immittance test battery consisting of a 
tympanogram and acoustic reflex threshold testing. Stimuli will not exceed a level of 100 
decibels hearing level (dB HL). Finally, the wideband test battery will be performed with 
adults seated comfortably in a sound-treated booth. A small probe with a soft rubber tip 
will be inserted in the subject's ear canal, and the subject will be asked to remain quiet 
while sounds are presented to an ear via sound sources within the probe. Responses 
will be measured using a miniature microphone within the probe. The tests in the 
wideband battery are similar to the clinical admittance battery and include ambient 
absorbance, absorbance tympanometry and acoustic reflex threshold. The otoacoustic 
emission testing is a separate measurement of inner ear function typically conducted in 
the clinic using different equipment.