Teoae; About The Teoae Module; Teoae Testing; Automated Teoae With Sera Tm - Interacoustics Sera Additional Information

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TEOAE

About the TEOAE module

The Sera
with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders
TM
using Transient Evoked Otoacoustic Emissions. The target population for Sera
ages.
The TEOAE is to be used by trained personnel only, such as audiologists, ENT surgeons and doctors,
hearing healthcare professionals or personnel with a similar level of education. The device should not be
used without the necessary knowledge and training to understand its use and how results should be
interpreted.

TEOAE testing

Transient Evoked Otoacoustic Emissions (TEOAEs) are commonly used for infant hearing screening and in
diagnostic testing as they screen patients for cochlear hearing loss.
TEOAE technology uses a broadband click stimulus to assess the status of the outer hair cells within the
cochlea. Responses from the outer hair cells to the stimulus are predictable and therefore can be measured
via a sensitive microphone placed in the patient's ear canal.
It is ideal for testing newborns and infants as the patient does not need to be awake or respond in any way to
the test stimulus. Responses from the cochlea (outer hair cells) are recorded and results are automatically
analyzed and displayed as either PASS or REFER.
Automated TEOAE with Sera
The TEOAE module with Sera
presence or absence of an OAE response within various frequency bands. Prior to the start of the
measurement, the stimulus level is adjusted with reference to the ear canal volume to ensure the correct
stimulus level is presented to the test ear. Testing occurs by delivery of a sub-group of 4 broadband click
stimuli (8 subgroups = 1 sweep) multiple times and performing a sequence of signal processing operations to
optimally extract any TEOAE signal that is present in the responses to these stimuli. A time domain
averaging technique together with noise rejection and Bayesian weighting is used to obtain a sufficient signal
to noise ratio (SNR). The time-averaged responses (waveform) are stored in two memory buffers, labelled A
and B. If the patient has a normal OAE, it is these two responses which improve in signal quality (i.e.
increasing signal to noise ratio) as the data collection and averaging process progresses. These two
responses are then analyzed to assess whether an OAE is present and whetherto stop further data
collection. Once a minimum amount of data is recorded (50 sweeps), the detection algorithm can then label
each of the frequency bands as detected or not. The fundamental identifying factor is the presence of
sufficient SNR in a half octave frequency band. However, there are several qualifying factors that are
included in to the decision process such as the stability of the stimulus throughout the test, the level of noise,
and features in the response waveform that indicate a risk of a false response. When the minimum number
of frequencies bands required for the test to pass (as defined by the protocol) have been detected, the test
automatically stops and the test result is labelled a PASS. If the minimum number of frequencies bands
required for a PASS is not met during the maximum test time, the test ends with a REFER result. If the test
is stopped before a PASS is detected or before the maximum test time is exceeded, the test is labelled as
INCOMPLETE.
D-0114042-D – 2020/03
Sera™ - Additional Information
TM
uses a predefined protocol together with a detection algorithm to assess the
TM
with TEOAE includes all
TM
Page 29

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