• Audera Pro Clinical Evoked Potentials and OAE system from Grason-Stadler

    AUDERA PRO

    VERSATILE CLINICAL EP/OAE

    The Audera Pro™  is an evoked potential and otoacoustic emissions device from GSI. Equipped with the same great features as its predecessor, the Audera Pro also offers numerous updates to support the needs of a modern audiology practice.

    The GSI Audera Pro™ EP/OAE system is a compact yet versatile device, capable of performing all standard evoked potential tests. Depending on the modality license you select, ASSR (auditory steady state responses) and OAE (otoacoustic emissions) can also be included. The Audera Pro is the next generation to the well-known GSI Audera™ and comes with significant updates to support the demands of any busy practice. Some of the featured new tests include: P300/MMN, ASSR Binaural testing, transient evoked otoacoustic emissions (TEOAE), and Speech Stimuli for ABR. The hardware has been updated to provide a smaller footprint, an integrated pre-amplifier, lightweight cables, and the GSI OAE probe. The system also has modern waveform analysis tools such as Area Ratio for ECochG, application of digital filters, the ability to split alternating waveform into rarefaction and condensation components, cross correlation of waveforms, and automatic SNR (Signal-to-Noise Ratio) and RN (Residual Noise) calculation. Since it's capable of performing so many tests, the Audera Pro makes the perfect choice for clinics that need to comprehensively evaluate, identify, document, and diagnose auditory and vestibular disorders on all patient populations.

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FREQUENTLY ASKED QUESTIONS

What configurations are available with the GSI Audera Pro?

Available configurations on the Audera Pro include AEP only, AEP and ASSR, AEP and TEOAE/DPOAE, TEOAE/DPOAE only, and a full configuration that includes all test modalities AEP/ASSR/TEOAE/DPOAE.

What tests can be performed with the AEP test modality?

The following tests are available with the AEP test modality: ECochG, ABR, MLR, LLR and SN10. In addition, eABR, P300, MMN as well as oVEMP/cVEMP protocols are included.

Is it possible to record bone conduction ASSR?

Yes, the Audera Pro includes this feature. It is possible to record ASSRs with all AEP transducers, including insert earphones, headphones, bone oscillator, and the optional amplified speakers.

What OAE tests can be performed with the Audera Pro?

The following tests are available: screening (pass/refer) protocols, diagnostic protocols, spontaneous OAE, and DP input/output functions.

Are there objective tools for analyzing waveforms?

The Audera Pro includes a variety of objective analysis tools such as cross correlation, SNR, and RN. SNR and RN are objective tools that assist the clinician in determining the presence or absence of a response. Cross correlation is a statistical tool that provides an objective estimate of the similarity of two waveforms. The higher the correlation value, the more similar the waveforms are with “1” being perfect correlation. Signal to Noise Ratio (SNR) is the ratio of the response from the patient (the ABR, or auditory brainstem response) vs the noise such as the EEG or EMG activity. Residual Noise (RN) is the amount of noise that remains in the response. When a response is present, the SNR should increase, and the RN should decrease during the collection as more sweeps are averaged. The Audera Pro displays RN and SNR for the active waveform as well as saved waveforms.

OAE testing on an infant with the Audera Pro

COMPREHENSIVE BATTERY OF TEST TYPES

The GSI Audera Pro comes equipped with a comprehensive battery of evoked potentials and otoacoustic emissions test types. Optional modality licenses may be purchased, allowing you to perform a combination of different tests: AEP, ASSR, DPOAE, and TEOAE.

 

PRODUCT SPECS

DIMENSIONS AND WEIGHT

• L x W x H: 12 x 15 x 3 in (30.48 x 38.1 x 7.62 cm)
• Weight: 4.4 lb (1995 g)

GENERAL SPECIFICATIONS

• Evoked Potentials: ECochG, ABR, MLR, LLR, SN10, P300, MMN, VEMP, ASSR
• Otoacoustic Emissions: DPOAE, TEOAE, SPOAE
• Warm Up Time: None at room/operating temperature

TRANSDUCERS

• RadioEar IP30 Insert Earphones: Frequency Range: 125 Hz-8000 Hz, Output Level: -10 to 132 dB SPL
• RadioEar DD45 Headphones: Frequency Range: 125 Hz-8000 Hz, Output Level: -10 to 120 dB SPL
• RadioEar B81 Bone Conductor: Frequency Range: 250 Hz-8000 Hz, Output Level: -10 to 109 dB SPL
• GSI OAE Probe: Frequency Range: 300 Hz-12,000 Hz, Output Level: 40 to 83 dB SPL
• RadioEar SP90A Speaker: Frequency Range: 100 Hz-8000 Hz, Output Level: -10 to 90 dB SPL

EP STIMULUS SPECIFICATIONS

• Stimulus Types: Click, CE-Chirp, Tones, CE-Chirp Octave Bands, Speech stimuli, User File
• Click Duration: 100 uSec default (adjustable)
• Tone Duration: Up to 500 ms (adjustable)
• Tone Window Types: Rectangular, Hann, Blackman, Gaussian, Trapezoidal, Extended Cosine
• Rate: 0.1 to 100 per second
• Polarity: Rarefaction, Condensation, Alternating

 

MASKING

• Type: White noise, specific level or relative to stimulus level
• Frequency Response: Flat to 20 kHz (transducer limits determine roll off)
• Maximum Output: 125 dB SPL
• D/A: 16-bit
• Level Accuracy: ±1 dB
• Attenuation Range: 150 dB
• Frequency Accuracy: ±1%
• Total Harmonic Distortion: < 1% (DD45), < 3% (IP30), < 2% (B81), < .1% (SP90A)

EP AMPLIFIER SPECIFICATIONS

• Number of Channels: 2 
• Gain: 5000-200,000 (adjustable)
• High Pass Filters: 0.1 Hz-300 Hz (adjustable) (-6 dB/Oct., -24dB/Oct. for 70 Hz)
• Low Pass Filters: 30 Hz-5000 Hz (adjustable) (-6 dB/Oct., -24dB/Oct. for 500 Hz)
• Sampling Rate: 200-40,000 Hz (adjustable)
• A/D: 16-bit
• Common Mode Rejection: ≥ 110 dB @ 1 kHz, 50/60 Hz
• Input Impedance: > 10 M Ohm
• Noise Level: ≤ 0.27 uV RMS 
• Artifact Rejections: Adjustable level (0-100%) and any region within the analysis time window
• Line Frequency Filter: 50 or 60 Hz, -12 dB/Octave
• Recording Window: -2.5 sec to 2.5 sec (maximum)
• Data Points per Waveform: 1024
• Digital Filters: Finite Impulse Response (FIR), band pass and notch
• Electrode Impedance Measuring frequency: 1000 Hz, Range: 1-25k Ohm

 

 

OAE SPECIFICATIONS

• Sample Rate: 40k Hz
• A/D: 16-bit
• Frequency Accuracy: ±1% from selected
• Frequency Analysis (FFT) Points: DPOAE: 4096, TEOAE: 1024
• Frequency Resolution: DPOAE: 9.8 Hz, TEOAE: 39.1 Hz
• Acquisition Time: DPOAE: 102.24 ms, TEOAE: 25.56 ms

 

STIMULI - TEOAE

• Stimulus: 75 uS click
• Presentation: Linear or non-linear train
• Level: 80 dB SPL (user defined 0-95 dB SPL)
• Stimulus Rate: 1-50/s (user defined)
• Analysis Frequencies: 1000-4000 Hz

 

STIMULI - DPOAE

• Stimulus: 2 Pure Tones (500-12000 Hz user defined start, end and F2/F1 ratio)
• Levels: 65/55 (user defined L1, L2, 0-80 dB SPL)
• Steps per Octave: 1-10 (user defined)

POWER

INTERNAL POWER SUPPLY

• Input Voltage: 100-240 VAC, 350-150 mA
• Input Frequency: 50-60 Hz
• Internal Fuse: Time lag fuse rated to 2A, 250V

ENVIRONMENTAL

Transport package shall be kept away from rain and stored in dry conditions.

• Operating Temperature: +59° F (+15° C) to +95° F (+35° C)
• Transport Temperature: -4° F (-20° C) to +122° F (+50° C)
• Storage Temperature: +32° F (0° C) to + 122° F (+ 50° C)
• Operating Relative Humidity: Maximum 90%, non-condensing at 104° F (40° C)
• Transport & Storage Relative Humidity: Maximum 93% (non-condensing)
• Ambient Air Pressure: 98 kPa-104 kPa
• Maximum Altitude: 9843 feet (3000 m) above sea level
• Location: Indoor use, quiet environment
• Mode of Operation: Continuous
• Degree of Mobility: Portable equipment
• Vibration and Shock: Not applicable

QUALITY SYSTEM

Manufactured, designed, developed, and marketed under ISO 13485 certified quality systems.

REGULATORY
The Audera Pro is an active, diagnostic medical product. The device is classified as a class IIa device according to the EU medical device directive 93/42/EEC and a class II device according to the US FDA.
COMPLIANCE

• Safety and Electromagnetic compatibility (EMC): IEC 60601-1, Type B and BF applied parts, IEC 60601-1-2, IEC 60601-2-40
• Calibration and Test Signal: ISO 389-2, ISO 389-6, IEC 60645-3
• OAE: IEC 60645-6: 2009, Type 1
• EP (ABR): IEC 60645-7: 2009, Type 1
• Protection from Fluids: IPX0 – Ordinary equipment

  • Audera Pro features multiple analysis

    MULTIPLE ANALYSIS TOOLS

    The Audera Pro includes a variety of objective analysis tools such as cross correlation of two waveforms, real time signal to noise ratio (SNR), and residual noise (RN) estimates to assist the clinician in validating test data from any patient population.

  • Audera Pro features efficient data collection

    EFFICIENT DATA COLLECTION

    Modules of the Audera Pro feature predefined protocols and normative data. On screen options allow for changes in real time. Customized protocols may be added to meet individual testing needs.

  • Audera Pro features CE-Chirp

    LARGER AMPLITUDE WITH CE-CHIRP

    Save time and increase clinical confidence by using the CE-Chirp and CE-Chirp Octave Band stimuli, which have been shown to result in auditory brainstem response amplitudes that are up to two times larger than with traditional test stimuli.

Audera Pro evoked potentials testing

ORGANIZED DATA

Reporting is clear and concise, allowing test results to be easily organized, combined, and interpreted by busy clinicians. All test modules on the Audera Pro feature data organization designed with efficiency in mind. This includes multiple pages available in a single report to include ABR, ASSR, and OAE data.

Key System Features

  • 1. ARRAY OF SETUP OPTIONS

    The system includes a comprehensive battery of evoked potentials test types including ECochG, ABR, MLR, LLR, SN10, P300/MMN, ASSR, and eABR.

  • 2. STATISTICAL CROSS CORRELATION

    Quickly obtain an objective estimate of the similarity of two waveforms. The higher the correlation value, the more similar the waveforms.

  • 3. SPLITTING ACTIVE RECORDING

    Collect a waveform using alternating polarity and split into rarefaction and condensation waveforms.

  • 4. DIGITAL FILTERING

    After a waveform has been collected, digital high-pass and low-pass filters can be applied to the saved waveform.

  • 5. STIMULI OPTIONS

    The Audera Pro gives you options with classic test stimuli of clicks and tone bursts with the added benefit of the CE-Chirp, CE-Chirp Octave Band, and speech stimuli.

  • 6. SMALL AND CONFIGURABLE FOOTPRINT

    With a small and sleek footprint, the Audera Pro may be placed vertically in a stand, underneath a laptop, or mounted on the wall. It's the perfect solution for any size audiology practice or ENT clinic.

  • Evoked potentials testing screen

    EP

    The following tests are available: ECochG, ABR, MLR, LLR, and SN10. Also included are P300 and MMN protocols and eABR protocols. Traditional test stimuli of click and tone bursts, CE-Chirp and CE-Chirp Octave Bands, and speech stimuli are included.

  • ASSR testing screen

    ASSR

    Test stimuli include pure tones of 250, 500, 1000, 2000, 4000, and 8000 Hz. Present up to four frequencies in both ears at the same time for a total of eight frequencies.

  • DPOAE testing screen

    DPOAE

    The following tests are available with DPOAE: screening (pass/refer) protocols, diagnostic protocols, customizable protocols, and DP input/output functions.

  • TEOAE testing screen

    TEOAE

    The following tests are available with TEOAE: screening (pass/refer) protocols, customizable protocols, and spontaneous OAE (SOAE).

FEATURED VIDEOS

  • Software Tutorial

    ABR Tutorial

  • Software Tutorial

    ASSR Tutorial

  • Software Tutorial

    Software Demo

Audera Pro EP-OAE system with stand set up and a computer screen with evoked potentials data

MULTIPLE SETUP OPTIONS

The Audera Pro can be set up in a variety of ways to best fit your workspace. The device can be placed horizontally under a laptop, vertically in the stand, or mounted on the wall.

 

Visit the Evoked Potentials Page and OAE Page for a full list of available GSI devices.

 

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