Abris; About The Abris Module; Automated Abr Testing; Automated Abr With Sera - Interacoustics Sera Additional Information

ABRIS

About the ABRIS module

The Sera with ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve
TM
disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The
target population for Sera
The ABRIS 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.

Automated ABR testing

Automated ABR testing is commonly used for infant hearing screenings as it tests the entire auditory system
up to the brainstem.
Automated ABR technology uses a broadband stimulus such as a click or CE-Chirp
using a fast stimulus rate. Electrodes are placed on the baby and record the brain activity (EEG) that is
evoked during presentation of the stimulus. Advanced algorithms are used to determine if there is a
response to the stimulus in the recorded EEG.
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 brainstem are detected from electrodes that are attached to the head
of the neonatal patient. Results are automatically analyzed and displayed as either PASS or REFER.

Automated ABR with Sera™

The ABRIS module with Sera
a fast stimulus rate (90Hz).
The algorithm is a multiple q-sample test with a critical test value set to a sensitivity of 99.9% and was
developed by Stürzebecher et al. (1999
The algorithm assesses the incoming EEG in the frequency domain assessing amplitude and phase at a
range of harmonics of the response to the periodic stimulus. By measuring a large number of EEG-
responses, and performing a frequency analysis on the data, it is possible to calculate a test value, which
gives an indication of the phase stability for the frequencies equal to the stimulus rate and the first 8
harmonics. Comparing the phase stability with a mathematically found critical test value, it is possible to
determine if there is a response to the stimulus in the EEGs. The calculation is performed everyone and a
half seconds, and if the test value is greater than or equal to the critical test value the algorithm returns a
"PASS". If the test value has not reached the critical test value before the maximum test time (180 seconds),
the algorithm returns a "REFER".
The critical test value for PASS/REFER cannot be modified.
1
Stürzebecher, E., Cebulla, M., & Wernecke, K.D. (1999). Objective response detection in the frequency domain:
Comparison of several q-sample tests. Audiol Neurootol, 4, 2-11
2
Cebulla, M., Stürzebecher, E., Elberling, C. (2006). Objective detection of auditory steady-state responses: Comparison
of one-sample and q-sample tests. J Am Acad Audiol, 17(2), 93-103.
D-0114042-D – 2020/03
Sera™ - Additional Information
with ABRIS is newborns.
TM
performs Automated ABR by stimulating the ear with a click or CE-Chirp® at
TM
) and later improved by Mario Cebulla and colleagues (2006
1
.
to stimulate the ear
®
).
2
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