AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

K122496 · Bio-Logic Systems Corp. · EWO · Nov 1, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K122496
• Device Name: AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
• Applicant: Bio-Logic Systems Corp.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Nov 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Handheld, battery-operated OAE measurement system; uses Bio-logic ear probe with miniature receivers and microphone. Device delivers controlled acoustic stimuli to ear canal; records evoked emissions from outer hair cells. System performs TEOAE and DPOAE tests; collects/averages data until parameters met. Operated by trained healthcare professionals/supervised personnel in clinical settings. Features LCD for real-time data display, pass/refer recommendations, and graphic review. Data can be exported to PC-based databases (P&TI) or hearing tracking systems (HATS) for analysis. Provides objective assessment of cochlear function; aids clinical decision-making for patients unable to provide reliable behavioral responses.

Clinical Evidence

Bench testing only. Verification and validation performed to ensure device meets performance specifications and demonstrates equivalence to predicate devices. No clinical data presented.

Technological Characteristics

Handheld, battery-operated (rechargeable Li-ion). Uses Bio-logic OAE ear probe (miniature receivers/microphone). Connectivity via RS-232/USB to PC. Standards: IEC 60601-1, IEC 60601-1-2, CISPR 11. Software: Firmware written in assembly code for stimulus control/data collection. Biocompatibility: Ear tips per ISO 10993-1 (cytotoxicity, sensitization, irritation).

Indications for Use

Indicated for patients of all ages (newborns to geriatric) to assess cochlear function via TEOAE and DPOAE testing. Especially indicated for individuals where behavioral audiometric testing is unreliable, such as infants, young children, and cognitively impaired adults.

Regulatory Classification

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.

Predicate Devices

• AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function (K111618)
• ABaer with ABaer I/O (K112247)
• Otoport (K072033)

Submission Summary (Full Text)

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K122496

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

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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

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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.

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# Comparison Table

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| | AuDX with AuDX I/O<br>Function | ABaer with ABaer I/O<br>Function | Otodynamics Otoport | AuDX Pro |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate 510(k)<br>number | K111618 | K112247 | K072033 | New device |
| Intended Use | To measure or<br>determine cochlear<br>function via<br>performing transient<br>evoked otoacoustic<br>emissions (TEOAE),<br>distortion product<br>otoacoustic emissions<br>(DPOAE) and<br>determining DPOAE<br>Input / Output (I/O)<br>functions. | Performs an<br>automated auditory<br>evoked response<br>(ABaer) screening<br>and/or an automated<br>otoacoustic emissions<br>(AOAE) screening.<br>The device performs<br>TEOAE and DPOAE<br>tests and determining<br>DPOAE Input / Output<br>(I/O) functions. | Can perform automated<br>TEOAE and DPOAE<br>based measurements<br>via an ear probe,<br>including I/O<br>functionality. | To measure or<br>determine cochlear<br>function via<br>performing transient<br>evoked otoacoustic<br>emissions (TEOAE)<br>and distortion product<br>otoacoustic emissions<br>(DPOAE). |
| User | Trained health care<br>professionals | Same | Same | Same |
| Patient Population | Newborn infants<br>through adults, to and<br>including geriatric<br>patients. Especially for<br>use in testing<br>individuals where<br>behavioral audiometric<br>results are unreliable. | Same | Same | Same |
| Anatomical sites | External ear canal | External ear canal<br>for OAE and for<br>ABR testing; scalp,<br>ear and other skin<br>sites proper for<br>surface electrode.<br>placement. | External ear canal | External ear canal |
| Noninvasive | Yes | Yes | Yes | Yes |
| Physical Form | Standalone handheld<br>system that can be<br>connected to a PC. | PC based system<br>with handheld size<br>external data<br>acquisition box. | Standalone handheld<br>system. | Standalone handheld<br>system that can be<br>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<br>Pass/Refer<br>recommendation | Yes | Yes | Yes | Yes |
| Background noise<br>check during test | Yes | Yes | Yes | Yes |
| Measurement<br>based stopping<br>criteria | Yes | Yes | Yes | Yes |
| Performs in-the-<br>ear calibration | Yes | Yes | Yes | Yes |
| User customization<br>of test protocols | Yes - User has<br>control over DPOAE<br>I/O function test<br>parameters, but not<br>automated DPOAE or<br>TEOAE testing. | Yes - User has<br>control over DPOAE<br>I/O function test<br>parameters, but not<br>automated DPOAE or<br>TEOAE testing. | Yes, Can create, edit<br>and save user's own<br>test protocols and<br>pass/refer criteria for<br>automated DPOAE,<br>TEOAE and DPOAE I/O<br>testing. | Yes, Can create, edit<br>and save user's own<br>test protocols and<br>pass/refer criteria for<br>automated DPOAE<br>and TEOAE testing. |
| | AuDX with AuDX I/O<br>Function | ABaer with ABaer I/O<br>Function | Otodynamics Otoport | AuDX Pro |
| Predicate 510(k)<br>number | K111618 | K112247 | K072033 | New device |
| Fundamental<br>Scientific<br>Technology | Records data in the<br>form of acoustic<br>signals, i.e. OAE with<br>the use of an ear<br>probe. The probe<br>houses miniature<br>receivers to deliver a<br>stimulus and a<br>microphone to records<br>stimulus and the<br>resulting evoked<br>OAEs. The test<br>consists of either<br>measuring and<br>recording TEOAEs or<br>DPOAEs. Sensed<br>signals are amplified,<br>filtered and averaged<br>to improve the signal<br>quality and signal-to-<br>noise ratio. The<br>resulting recorded<br>measurements are<br>automatically<br>displayed and can be<br>evaluated for OAE<br>signals. I/O software<br>feature to the DPOAE<br>test suite provides<br>ability to allow the<br>user to change the<br>stimulus levels at<br>constant stimuli<br>frequencies and plot<br>the corresponding<br>stimulus amplitude vs<br>DPOAE level<br>functions to evaluate<br>the input/output<br>relations of the<br>generated DPOAEs at<br>specific frequency<br>regions as defined by<br>the user. | Same as K111618<br>with respect to OAE<br>testing (TEOAE,<br>DPOAE and DPOAE<br>I/O). Additionally, the<br>device performs<br>screening by<br>recording and<br>analyzing Auditory<br>Brainstem Responses<br>(ABR). | Can screen for cochlear<br>function using either<br>Transient Evoked or<br>Distortion Product<br>Otoacoustic Emissions<br>(TE or DPOAEs). It<br>uses an ear probe to<br>deliver stimulus and to<br>record evoked OAEs.<br>Recorded signals are<br>evaluated automatically<br>using signal analysis to<br>provide robust<br>indications of cochlear<br>function and high<br>immunity to extraneous<br>noise. Additionally, the<br>system includes I/O<br>functionality. | Same as K111618,<br>K112247 and<br>K072033 with respect<br>to TEOAE and<br>DPOAE. |
| Safety<br>Characteristics | No direct electrical<br>connection to the<br>patient. | Same | Same | Same |
| Energy delivered<br>to the patient | Audible acoustic<br>stimulus to the<br>subject's auditory<br>system. | Same | Same | Same |
| Energy delivered<br>to the patient | Audible acoustic<br>stimulus to the<br>subject's auditory<br>system. | Same | Same | Same |
| Energy delivered<br>to the patient | Audible acoustic stimulus<br>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)<br>number | Function<br>K111618 | Function<br>K112247 | K072033 | New device |
| Energy delivered<br>to the patient | Audible acoustic<br>stimulus to the<br>subject's auditory<br>system. | Same | Same | Same |
| Mechanical safety | No moving<br>mechanical parts in<br>contact with the<br>subject | Same | Same | Same |
| Electrical Safety<br>and Performance<br>Standards | CISPR 11, IEC 60601-1,<br>IEC 60601-1-1,<br>IEC 60601-1-2,<br>IEC 610003-2,<br>IEC 610003-3,<br>IEC 610004-2,<br>IEC 610004-3,<br>IEC 610004-4,<br>IEC 610004-5,<br>IEC 610004-6,<br>IEC 610004-8,<br>IEC 610004-11,<br>IEC 60101-1-4 | CISPR 11, IEC 60601-1,<br>IEC 60601-1-1,<br>IEC 60601-1-2,<br>IEC 610003-2,<br>IEC 610003-3,<br>IEC 610004-2,<br>IEC 610004-3,<br>IEC 610004-4,<br>IEC 610004-5,<br>IEC 610004-6,<br>IEC 610004-8,<br>IEC 610004-11,<br>IEC 60101-1-4 | BS EN 60601-1,<br>BS EN 60601-1-1,<br>BS EN 60601-1-2,<br>BS EN 60601-1-4 | CISPR 11,<br>IEC 60601-1 + Coor. 2,<br>IEC 60601-1-2 + A1,<br>IEC 610003-2,<br>IEC 610003-3 + A1 +<br>IEC 610004-2,<br>IEC 610004-3,<br>IEC 610004-4,<br>IEC 610004-5,<br>IEC 610004-6,<br>IEC 610004-8,<br>IEC 610004-11,<br>IEC 60101-1-4 |
| Battery powered<br>hardware (Battery<br>type) | Yes (Rechargeable<br>Lithium Ion Battery) | No (6 V DC) | Yes (Rechargeable Lithium<br>polymer) | Same as K111618 |
| Data display | Information displayed<br>on the AuDX screen<br>and the PC monitor<br>screen for the AuDX<br>I/O | Information displayed<br>on computer monitor<br>screen. | Information displayed<br>on the Otoport device<br>screen. | Information displayed<br>on the device's LCD<br>screen and can be<br>displayed on a<br>computer monitor<br>screen. |
| Built in keys for<br>user interface on<br>the collection box | Yes; 5-keys | No | Yes | Yes, 7-keys |
| Computer<br>compatibility | IBM compatible PC. | Same | Same | Same |
| Operating System | Windows for host PC<br>for AuDX I/O and<br>utilities. No OS for the<br>AuDX hardware<br>device. | Windows® 2000,<br>Windows® XP,<br>Windows® 7 | Windows 2000/XP/Vista<br>for PC based utilities | No OS for the AuDX<br>hardware device. |
| Communication with<br>PC | RS-232 and USB | RS-232 and USB | USB | RS-232 and USB |
| System Design | With respect to<br>TEOAE and DPOAE,<br>the main stimulus<br>generation and data<br>acquisition hardware<br>connected to OAE<br>probe. For the AuDX<br>I/O functionality, the<br>main stimulus<br>generation and data<br>acquisition hardware<br>connected to OAE<br>probe and a personal<br>computer hosting<br>testing software, data<br>display and user<br>interface. | Main stimulus<br>generation and data<br>acquisition hardware<br>connected to patient<br>cables, transducers<br>and personal<br>computer hosting<br>testing software, data<br>display and user<br>interface. | Main stimulus<br>generation and data<br>acquisition hardware<br>connected to OAE<br>probe and hosting the<br>testing software, data<br>display and user<br>interface functionality<br>without a need to<br>connect to PC. | Main stimulus<br>generation and data<br>acquisition hardware<br>connected to OAE<br>probe. |
| | AuDX with AuDX I/O.<br>Function | ABaer with ABaer I/O<br>Function…