Pass/Refer Criteria
Pass/Refer Criteria for DPOAE
The decision that a DPOAE exists is based on detecting a signal whose level is
significantly above the background noise level. This requires a statistical
decision, since the random noise level in the DPOAE filter channel can be
expected to exceed the average of the random noise levels in the four adjacent
filter channels -- used as the reference for comparison -- roughly half the
time.
Extended measurements of the noise distributions in both the DPOAE filter channel
"DP level" and the rms average of the 4 adjacent channels "N level" indicate
that the signal-to-noise ratio (the difference between DP and N) has a standard
deviation of 5.5 dB. As shown in the figure below, this implies a 10%
probability of seeing a 7 dB SNR simply from the variability of the noise
levels in the 2 filter sets.
Requiring an SNR of 6 dB in three out of four frequencies drops the probability of
passing an ear with significant hearing loss to 1% or less. Note: By the
binomial distribution, two of three frequencies at >8.4 dB or three of six
frequencies at >7 dB should also ensure less than 1% probability of passing
a moderately-severe hearing-impaired infant.
Preliminary ERO•SCAN trials with newborns indicate that the tester's technique is
the single most important variable in the pass rate on normal-hearing infants.
Some testers pick up the technique with only a couple of days' practice,
producing pass rates comparable to those for other DPOAE equipment they have
used for months; other testers take longer.
Note: The easiest way to obtain a PASS is to a) make sure the eartip is fully seated
on the probe tip and b) make sure the eartip is as deeply seated in the ear
canal as possible.
Occasional claims of extraordinarily low probabilities of missing an ear with
hearing loss appear to be based on poor statistics. As discussed by Gorga (Mayo
Clinic Teleconference,1998), since the incidence of significant hearing loss is
roughly 2 per 1000, verifying a 99.7% accuracy would require testing hundreds
of thousands of babies with a given system. Thus to demonstrate that only 3
babies out of 1000 with hearing loss were missed would require follow-up
testing on 500,000 babies. To our knowledge, no one has performed such tests to
date.
Pass/Refer Criteria for TEOAE
The same basic
principles that underlie DPOAE Pass/Fail criteria underlie TEOAE Pass/Fail
criteria. In the case of transients, requiring SNR of 4 dB at any three out of
the six test frequencies drops the probability of passing an ear with a
significant hearing loss to less than 1%.
Note: The SNR limits for transients are lower than the corresponding limits for
distortion products primarily because the traditional noise calculation used in
TEOAE measurements (and in the ERO•SCAN instrument) gives a 3 dB lower SNR than
the calculation used for DPOAEs. Without that difference, the numerical SNR
value for a PASS with the two methods would be quite similar.
The ERO•SCAN uses a novel noise-rejection algorithm (patent pending) that permits
accurate DPOAE and TEOAE measurements in background noise and babble as high as
70 dB SPL (A-weighted). Briefly explained, use of available memory in the
ERO•SCAN processor permits a post-hoc statistical analysis that identifies
those samples whose retention would improve the overall accuracy. Those samples
are included in the final analysis; the noisier samples are rejected.
The improved operation in noise with the new algorithm was so substantial that we
conducted a complete replica of our original validation tests in "fully
impaired ear" cavities and were able to verify that no increase in false
negatives (false passes) was introduced. Under no test conditions was any such
degradation uncovered.
The artifact rejection can only reject the noisiest samples in a measurement period.
If the ambient noise level rises too high (and/or the eartip seal is poor),
then all samples will be noisy and accurate measurements will be impossible, in
which case the test result will indicate "noisy."