(77 days)
Not Found
No
The document describes a system for measuring otoacoustic emissions using hardware and software to generate and record acoustic signals. It mentions data collection, averaging, and comparison to normalized data for a pass/refer result. There is no mention of AI, ML, or related concepts like training sets, test sets, or complex algorithms beyond standard signal processing and data comparison.
No.
The device measures otoacoustic emissions to assess cochlear function, which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate any condition.
Yes
The device performs otoacoustic emissions testing to assess cochlear function and provides a "pass or refer" result, which indicates a diagnostic purpose.
No
The device description explicitly states it is a "handheld battery operated device" and uses a "combination of hardware and software" including an "ear probe" with embedded receivers and a microphone. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the AuDX Pro Otoacoustic Emissions Measurement System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AuDX Pro Function: The AuDX Pro works by delivering acoustic signals into the ear canal and measuring the resulting physical response (otoacoustic emissions) generated by the inner ear. It does not analyze biological specimens.
- Intended Use: The intended use is to assess cochlear function by measuring a physical response, not by analyzing biological samples.
Therefore, the AuDX Pro falls under the category of a diagnostic device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AuDX Pro Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The AuDX Pro device performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests.
AuDX Pro is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function.
The device can be used for patients of all ages, from newborn infants through adults, to include geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.
Product codes (comma separated list FDA assigned to the subject device)
EWO
Device Description
The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. The AuDX Pro system includes optional software selections distinguished by the AuDX Pro, AuDX Pro II, and AuDX Pro Plus naming designations.
The test consists of measuring and recording transient (clickevoked) otoacoustic emissions (TEOAE) or distortion product otoacoustic emissions (DPOAE) utilizing pure tones. The same ear probe is used for both types of tests. For transient otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes appear on the LCD display on the front of the AuDX Pro unit. For distortion product otoacoustic emissions (DPOAEs), the DPOAE and noise floor amplitudes appear on the LCD. A pass or refer result is assigned at the end of the test based on a comparison of the patient's OAE response to normalized data. Additionally, a graphic display of the data is presented on the LCD allowing users to view and/or analyze the results.
The data collected by the AuDX system can be sent to a host computer where it can be saved or placed in a database. Optional Natus software programs are available for that function. Natus software programs provide a mechanism for users to define their own specific test protocols and download them to the AuDX Pro device.
The AuDX Pro Otoacoustic Emissions Measurement System expands upon the capabilities of the AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function [K111618]. The AuDX Pro System provides the following enhancements over the AuDX System:
- Protocol Setup utilities to load expanded frequency . protocols to the AuDX Pro:
- Options to upload data to a PC based Patient and Test . Information Database (P&TI);
- . Options to graphically review data from a PC based Hearing Assessment & Tracking System (HATS) software utility linked with the P&TI Database; and.
- . A Graphical User Interface (GUI) on an enhanced LCD screen for testing, patient information, and data review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
External ear canal
Indicated Patient Age Range
Newborn infants through adults, to and including geriatric patients.
Intended User / Care Setting
Trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications and demonstrates equivalence to the specified predicate devices.
The verification and validation summary report and risk analysis documentation provided in this 510(k) support the conclusion that the AuDX Pro Otoacoustic Emissions Measurement System is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
0
NOV
1 2012
510(k) SUMMARY
Manufacturer's Name:
Natus Medical Incorporated One Bio-logic Plaza Mundelein, IL 60060
Corresponding Official:
Telephone Number: Fax Number:
Timothy Karlovsky Quality and Regulatory Assurance Manager Natus Medical Incorporated One Bio-logic Plaza Mundelein, IL 60060 847.573.5430 847.949.8615
Summary Date:
October 23, 2012
Trade Name:
and Number:
Classification Name
Common or Usual Name: Audiometer
Audiometer 21 CFR 874.1050, Product Code: EWO
AuDX Pro Otoacoustic Emissions Measurement System
Predicate Devices:
K111618 AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function
K112247 ABaer with ABaer I/O
K072033 Otoport
Device Description:
The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. The AuDX Pro system includes optional software selections
1
distinguished by the AuDX Pro, AuDX Pro II, and AuDX Pro Plus naming designations.
The test consists of measuring and recording transient (clickevoked) otoacoustic emissions (TEOAE) or distortion product otoacoustic emissions (DPOAE) utilizing pure tones. The same ear probe is used for both types of tests. For transient otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes appear on the LCD display on the front of the AuDX Pro unit. For distortion product otoacoustic emissions (DPOAEs), the DPOAE and noise floor amplitudes appear on the LCD. A pass or refer result is assigned at the end of the test based on a comparison of the patient's OAE response to normalized data. Additionally, a graphic display of the data is presented on the LCD allowing users to view and/or analyze the results.
The data collected by the AuDX system can be sent to a host computer where it can be saved or placed in a database. Optional Natus software programs are available for that function. Natus software programs provide a mechanism for users to define their own specific test protocols and download them to the AuDX Pro device.
The AuDX Pro Otoacoustic Emissions Measurement System expands upon the capabilities of the AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function [K111618]. The AuDX Pro System provides the following enhancements over the AuDX System:
- Protocol Setup utilities to load expanded frequency . protocols to the AuDX Pro:
- Options to upload data to a PC based Patient and Test . Information Database (P&TI);
- . Options to graphically review data from a PC based Hearing Assessment & Tracking System (HATS) software utility linked with the P&TI Database; and.
- . A Graphical User Interface (GUI) on an enhanced LCD screen for testing, patient information, and data review.
Intended Use:
The AuDX Pro Otoacoustic Emissions Measurement System is indicated for use when it is necessary for a trained health care professional to assess cochlear function. The device can be used for patients of all ages, from newborn infants through adults, to include geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral responses are deemed
2
unreliable, such as infants, young children, and cognitively impaired adults.
The AuDX Pro Otoacoustic Emissions Measurement System performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests. Using a combination of hardware and software, the AuDX system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the inner ear as a result of normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. For transient evoked otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes are calculated and presented to the user. For distortion product otoacoustic emissions (DPOAEs), the DP and noise floor amplitudes are calculated and presented to the user. A pass or refer recommendation is assigned automatically at the end of the test based on user defined custom protocols or default test protocols and measured OAE test parameters. The AuDX Pro Otoacoustic Emissions Measurement System is equivalent to the devices cleared under K111618. K112247, and K072033.
Nonclinical Tests:
Technological Characteristics:
Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications and demonstrates equivalence to the specified predicate devices.
The verification and validation summary report and risk analysis documentation provided in this 510(k) support the conclusion that the AuDX Pro Otoacoustic Emissions Measurement System is safe and effective.
3
Comparison Table
:
.
| | AuDX with AuDX I/O
Function | ABaer with ABaer I/O
Function | Otodynamics Otoport | AuDX Pro |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate 510(k)
number | K111618 | K112247 | K072033 | New device |
| Intended Use | To measure or
determine cochlear
function via
performing transient
evoked otoacoustic
emissions (TEOAE),
distortion product
otoacoustic emissions
(DPOAE) and
determining DPOAE
Input / Output (I/O)
functions. | Performs an
automated auditory
evoked response
(ABaer) screening
and/or an automated
otoacoustic emissions
(AOAE) screening.
The device performs
TEOAE and DPOAE
tests and determining
DPOAE Input / Output
(I/O) functions. | Can perform automated
TEOAE and DPOAE
based measurements
via an ear probe,
including I/O
functionality. | To measure or
determine cochlear
function via
performing transient
evoked otoacoustic
emissions (TEOAE)
and distortion product
otoacoustic emissions
(DPOAE). |
| User | Trained health care
professionals | Same | Same | Same |
| Patient Population | Newborn infants
through adults, to and
including geriatric
patients. Especially for
use in testing
individuals where
behavioral audiometric
results are unreliable. | Same | Same | Same |
| Anatomical sites | External ear canal | External ear canal
for OAE and for
ABR testing; scalp,
ear and other skin
sites proper for
surface electrode.
placement. | External ear canal | External ear canal |
| Noninvasive | Yes | Yes | Yes | Yes |
| Physical Form | Standalone handheld
system that can be
connected to a PC. | PC based system
with handheld size
external data
acquisition box. | Standalone handheld
system. | Standalone handheld
system that can be
connected to a PC. |
| DPOAE | Yes | Yes | Yes | Yes |
| I/O function | Yes | Yes | Yes - Otoport Advance | No |
| TEOAE | Yes | Yes | Yes | Yes |
| ABR | No | Yes | No | No |
| Can provide
Pass/Refer
recommendation | Yes | Yes | Yes | Yes |
| Background noise
check during test | Yes | Yes | Yes | Yes |
| Measurement
based stopping
criteria | Yes | Yes | Yes | Yes |
| Performs in-the-
ear calibration | Yes | Yes | Yes | Yes |
| User customization
of test protocols | Yes - User has
control over DPOAE
I/O function test
parameters, but not
automated DPOAE or
TEOAE testing. | Yes - User has
control over DPOAE
I/O function test
parameters, but not
automated DPOAE or
TEOAE testing. | Yes, Can create, edit
and save user's own
test protocols and
pass/refer criteria for
automated DPOAE,
TEOAE and DPOAE I/O
testing. | Yes, Can create, edit
and save user's own
test protocols and
pass/refer criteria for
automated DPOAE
and TEOAE testing. |
| | AuDX with AuDX I/O
Function | ABaer with ABaer I/O
Function | Otodynamics Otoport | AuDX Pro |
| Predicate 510(k)
number | K111618 | K112247 | K072033 | New device |
| Fundamental
Scientific
Technology | Records data in the
form of acoustic
signals, i.e. OAE with
the use of an ear
probe. The probe
houses miniature
receivers to deliver a
stimulus and a
microphone to records
stimulus and the
resulting evoked
OAEs. The test
consists of either
measuring and
recording TEOAEs or
DPOAEs. Sensed
signals are amplified,
filtered and averaged
to improve the signal
quality and signal-to-
noise ratio. The
resulting recorded
measurements are
automatically
displayed and can be
evaluated for OAE
signals. I/O software
feature to the DPOAE
test suite provides
ability to allow the
user to change the
stimulus levels at
constant stimuli
frequencies and plot
the corresponding
stimulus amplitude vs
DPOAE level
functions to evaluate
the input/output
relations of the
generated DPOAEs at
specific frequency
regions as defined by
the user. | Same as K111618
with respect to OAE
testing (TEOAE,
DPOAE and DPOAE
I/O). Additionally, the
device performs
screening by
recording and
analyzing Auditory
Brainstem Responses
(ABR). | Can screen for cochlear
function using either
Transient Evoked or
Distortion Product
Otoacoustic Emissions
(TE or DPOAEs). It
uses an ear probe to
deliver stimulus and to
record evoked OAEs.
Recorded signals are
evaluated automatically
using signal analysis to
provide robust
indications of cochlear
function and high
immunity to extraneous
noise. Additionally, the
system includes I/O
functionality. | Same as K111618,
K112247 and
K072033 with respect
to TEOAE and
DPOAE. |
| Safety
Characteristics | No direct electrical
connection to the
patient. | Same | Same | Same |
| Energy delivered
to the patient | Audible acoustic
stimulus to the
subject's auditory
system. | Same | Same | Same |
| Energy delivered
to the patient | Audible acoustic
stimulus to the
subject's auditory
system. | Same | Same | Same |
| Energy delivered
to the patient | Audible acoustic stimulus
to the subject's auditory | Same | Same | Same |
| | AuDX with AuDX I/O, | ABaer with ABaer I/O | Otodynamics Otoport | AuDX Pro |
| Predicate 510(k)
number | Function
K111618 | Function
K112247 | K072033 | New device |
| Energy delivered
to the patient | Audible acoustic
stimulus to the
subject's auditory
system. | Same | Same | Same |
| Mechanical safety | No moving
mechanical parts in
contact with the
subject | Same | Same | Same |
| Electrical Safety
and Performance
Standards | CISPR 11, IEC 60601-1,
IEC 60601-1-1,
IEC 60601-1-2,
IEC 610003-2,
IEC 610003-3,
IEC 610004-2,
IEC 610004-3,
IEC 610004-4,
IEC 610004-5,
IEC 610004-6,
IEC 610004-8,
IEC 610004-11,
IEC 60101-1-4 | CISPR 11, IEC 60601-1,
IEC 60601-1-1,
IEC 60601-1-2,
IEC 610003-2,
IEC 610003-3,
IEC 610004-2,
IEC 610004-3,
IEC 610004-4,
IEC 610004-5,
IEC 610004-6,
IEC 610004-8,
IEC 610004-11,
IEC 60101-1-4 | BS EN 60601-1,
BS EN 60601-1-1,
BS EN 60601-1-2,
BS EN 60601-1-4 | CISPR 11,
IEC 60601-1 + Coor. 2,
IEC 60601-1-2 + A1,
IEC 610003-2,
IEC 610003-3 + A1 +
IEC 610004-2,
IEC 610004-3,
IEC 610004-4,
IEC 610004-5,
IEC 610004-6,
IEC 610004-8,
IEC 610004-11,
IEC 60101-1-4 |
| Battery powered
hardware (Battery
type) | Yes (Rechargeable
Lithium Ion Battery) | No (6 V DC) | Yes (Rechargeable Lithium
polymer) | Same as K111618 |
| Data display | Information displayed
on the AuDX screen
and the PC monitor
screen for the AuDX
I/O | Information displayed
on computer monitor
screen. | Information displayed
on the Otoport device
screen. | Information displayed
on the device's LCD
screen and can be
displayed on a
computer monitor
screen. |
| Built in keys for
user interface on
the collection box | Yes; 5-keys | No | Yes | Yes, 7-keys |
| Computer
compatibility | IBM compatible PC. | Same | Same | Same |
| Operating System | Windows for host PC
for AuDX I/O and
utilities. No OS for the
AuDX hardware
device. | Windows® 2000,
Windows® XP,
Windows® 7 | Windows 2000/XP/Vista
for PC based utilities | No OS for the AuDX
hardware device. |
| Communication with
PC | RS-232 and USB | RS-232 and USB | USB | RS-232 and USB |
| System Design | With respect to
TEOAE and DPOAE,
the main stimulus
generation and data
acquisition hardware
connected to OAE
probe. For the AuDX
I/O functionality, the
main stimulus
generation and data
acquisition hardware
connected to OAE
probe and a personal
computer hosting
testing software, data
display and user
interface. | Main stimulus
generation and data
acquisition hardware
connected to patient
cables, transducers
and personal
computer hosting
testing software, data
display and user
interface. | Main stimulus
generation and data
acquisition hardware
connected to OAE
probe and hosting the
testing software, data
display and user
interface functionality
without a need to
connect to PC. | Main stimulus
generation and data
acquisition hardware
connected to OAE
probe. |
| | AuDX with AuDX I/O.
Function | ABaer with ABaer I/O
Function | | AuDX Pro |
| Predicate 510(k)
number | K111618 | K112247 | | New device |
| Uses disposable ear
tips (silicon and foam
ear tips) | Yes | Yes | Yes | Yes |
| Biocompatibility | Ear tip materials are
classified by ISO 10993-
1 as surface-contacting
devices / limited
exposure to skin. Tests:
Cytotoxicity (ISO 10993-
5), Sensitization (ISO
10993-10), and Irritation
(ISO 10993-10) | Same | Info not available | Same |
| Sterility | None required | Same | Same | Same |
| Built-in LCD Screen
Transducers | Yes
Bio-logic OAE Ear Probe | Yes
Bio-logic OAE Ear Probe
for OAE tests. TDH-39
earphones, insert
earphones, bone
conductor oscillator for
ABR tests. | Yes
Otodynamics OAE ear
probe | Yes
Bio-logic OAE Ear Probe |
| Software and
Firmware | The handheld AuDX
hardware runs the
firmware written in
assembly code that
controls the stimulus
generation, data
collection and analysis
for OAE testing. The
AuDX I/O software
feature is written in
C++ language and
mainly provides the
convenient PC-based
user interface and
communicates with
the data collection
hardware. | Firmware is written
entirely in ADSP-219x
assembly language.
This allows for direct
and efficient control of
the DSP and
associated hardware.
Software is written in
Microsoft Visual
Studio C++. | Firmware controls the
stimulus presentation,
data collection and
evaluation. Specific
development language
is not available from
competitive product
information. | The handheld AuDX
Pro hardware runs
the firmware written in
assembly code that
controls the stimulus
generation, data
collection and
analysis for OAE
testing. |
| Reports | Data files can be
printed | A single patient report
can be printed based
on a default template.
Four types of multi-
patient reports are
available (basic,
extended, complete
and custom).
Additionally, statistical
reports can be
generated. | A single patient report
can be printed via
Otolink accessory
software. There are two
print formats: one to
print the results of a
single ear and the other
prints the results of two
tests, one for each ear. | Similarly, a single
patient report can be
printed. There are two
print formats: one to
print the results of a
single ear and the
other prints the
results of two tests,
one for each ear. |
| Patient & Test
Information
Database (P&TI) | No | Yes, includes
predefined fields,
customizable layout,
edit feature, search
feature, sort feature,
form & table views,
archival / copy
feature, backup
feature, repair
feature, compact
feature and import
tool. | Similarly, data can be
transferred to PC via
Otolink accessory
software. | Similarly, AuDX Pro is
able to store data in
and configure
common P&TI
database like ABaer. |
| | AuDX with AuDX I/O
Function | ABaer with ABaer I/O
Function | Otodynamics Otoport | AuDX Pro |
| Predicate 510(k)
number | K111618 | K112247 | K072033 | New device |
| Hearing
Assessment &
Tracking System
(HATS) | No | Yes. The HATS utility
enables AuDX Pro
data to be exported to
HiTrack via ABaer. | Similarly, Otolink
accessory software
enables transfer of data
to HiTrack. | Yes. The HATS utility
extracts data from the
AuDX Pro box and
enables the
exportation to HiTrack
via ABaer. |
| Microphone
frequency
response | 100 Hz - 10 kHz ± 3
dB | Same | Info not available | Same |
| Microphone
sensitivity (@1 kHz
re 1V/Pa) | -33 dB | Same | Info not available | Same |
| Speaker frequency
bandwidth | 100 Hz - 10 kHz ± 5
dB | 100 Hz - 10 kHz ± 5
dB | 500Hz-6000Hz | 100 Hz - 10 kHz ± 5
dB |
| System Signal-to-
noise ratio | -85 dB | Same | Same | Same |
| Speaker sensitivity | 90 dB SPL (@ 1kHz
re 1 VAC Drive) | 92 dB re 1 VAC | Info not available | 90 dB SPL (@ 1 kHz
re 1 VAC Drive) |
| Maximum stimulus
output |