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 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.

AI/ML Overview

The provided 510(k) summary for the AuDX Pro Otoacoustic Emissions Measurement System describes its technical characteristics and intended use, and compares it to predicate devices. However, it does not contain information about specific acceptance criteria, a dedicated study proving performance against acceptance criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in such studies for the AuDX Pro.

The document states: "Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications and demonstrates equivalence to the specified predicate devices." This is a general statement and does not provide the granular information requested by the prompt.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can be inferred or directly stated from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be fully provided as specific numeric acceptance criteria and resulting performance values are not detailed in the document. The comparison table primarily focuses on technical features, intended use, and safety characteristics in relation to predicate devices, rather than explicit performance metrics against predefined acceptance criteria.

The document implicitly suggests that the device meets performance specifications by stating "Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications and demonstrates equivalence to the specified predicate devices." However, these "performance specifications" are not listed with quantifiable acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not provided in the document. The 510(k) summary does not mention any specific test set, its size, or the provenance of any data used for performance validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not provided in the document. There is no mention of experts, ground truth establishment, or their qualifications in the context of a performance study for the AuDX Pro.

4. Adjudication Method for the Test Set

Not provided in the document. As there is no described test set or ground truth establishment process, an adjudication method is also not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable/Not performed according to the document. The AuDX Pro is an automated otoacoustic emissions measurement system. It performs the test and assigns a "pass or refer" result automatically based on a comparison to normalized data. The document does not describe any human reader involvement that an MRMC study would assess.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Implied, but details are not provided. The device is described as "automated" and assigns "pass or refer" results, suggesting standalone performance. However, the document does not describe a specific standalone performance study with detailed methodology, metrics, or results. It only states that "Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications."

7. Type of Ground Truth Used

Cannot be explicitly determined from the document for performance validation of the "pass/refer" outcome. The device compares OAE responses to "normalized data" to assign pass/refer. The nature of this "normalized data" (e.g., whether it's derived from expert consensus, pathology, or outcomes data) is not specified for the purpose of validating the device's accuracy in assigning these outcomes.

8. Sample Size for the Training Set

Not applicable/Not provided. The AuDX Pro is a measurement device that calculates biophysical parameters (reproducibility, difference value between TEOAE and noise floor, DPOAE and noise floor amplitudes). While it uses "normalized data" for its "pass or refer" algorithm, the document does not suggest the use of a machine learning model that would require a distinct "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. As there is no mention of a traditional training set for a machine learning algorithm, the establishment of ground truth for such a set is not discussed.

Summary

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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:

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distinguished by the AuDX Pro, AuDX Pro II, and AuDX Pro Plus naming designations.

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

	AuDX with AuDX I/OFunction	ABaer with ABaer I/OFunction	Otodynamics Otoport	AuDX Pro
Predicate 510(k)number	K111618	K112247	K072033	New device
Intended Use	To measure ordetermine cochlearfunction viaperforming transientevoked otoacousticemissions (TEOAE),distortion productotoacoustic emissions(DPOAE) anddetermining DPOAEInput / Output (I/O)functions.	Performs anautomated auditoryevoked response(ABaer) screeningand/or an automatedotoacoustic emissions(AOAE) screening.The device performsTEOAE and DPOAEtests and determiningDPOAE Input / Output(I/O) functions.	Can perform automatedTEOAE and DPOAEbased measurementsvia an ear probe,including I/Ofunctionality.	To measure ordetermine cochlearfunction viaperforming transientevoked otoacousticemissions (TEOAE)and distortion productotoacoustic emissions(DPOAE).
User	Trained health careprofessionals	Same	Same	Same
Patient Population	Newborn infantsthrough adults, to andincluding geriatricpatients. Especially foruse in testingindividuals wherebehavioral audiometricresults are unreliable.	Same	Same	Same
Anatomical sites	External ear canal	External ear canalfor OAE and forABR testing; scalp,ear and other skinsites proper forsurface electrode.placement.	External ear canal	External ear canal
Noninvasive	Yes	Yes	Yes	Yes
Physical Form	Standalone handheldsystem that can beconnected to a PC.	PC based systemwith handheld sizeexternal dataacquisition box.	Standalone handheldsystem.	Standalone handheldsystem that can beconnected 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 providePass/Referrecommendation	Yes	Yes	Yes	Yes
Background noisecheck during test	Yes	Yes	Yes	Yes
Measurementbased stoppingcriteria	Yes	Yes	Yes	Yes
Performs in-the-ear calibration	Yes	Yes	Yes	Yes
User customizationof test protocols	Yes - User hascontrol over DPOAEI/O function testparameters, but notautomated DPOAE orTEOAE testing.	Yes - User hascontrol over DPOAEI/O function testparameters, but notautomated DPOAE orTEOAE testing.	Yes, Can create, editand save user's owntest protocols andpass/refer criteria forautomated DPOAE,TEOAE and DPOAE I/Otesting.	Yes, Can create, editand save user's owntest protocols andpass/refer criteria forautomated DPOAEand TEOAE testing.
	AuDX with AuDX I/OFunction	ABaer with ABaer I/OFunction	Otodynamics Otoport	AuDX Pro
Predicate 510(k)number	K111618	K112247	K072033	New device
FundamentalScientificTechnology	Records data in theform of acousticsignals, i.e. OAE withthe use of an earprobe. The probehouses miniaturereceivers to deliver astimulus and amicrophone to recordsstimulus and theresulting evokedOAEs. The testconsists of eithermeasuring andrecording TEOAEs orDPOAEs. Sensedsignals are amplified,filtered and averagedto improve the signalquality and signal-to-noise ratio. Theresulting recordedmeasurements areautomaticallydisplayed and can beevaluated for OAEsignals. I/O softwarefeature to the DPOAEtest suite providesability to allow theuser to change thestimulus levels atconstant stimulifrequencies and plotthe correspondingstimulus amplitude vsDPOAE levelfunctions to evaluatethe input/outputrelations of thegenerated DPOAEs atspecific frequencyregions as defined bythe user.	Same as K111618with respect to OAEtesting (TEOAE,DPOAE and DPOAEI/O). Additionally, thedevice performsscreening byrecording andanalyzing AuditoryBrainstem Responses(ABR).	Can screen for cochlearfunction using eitherTransient Evoked orDistortion ProductOtoacoustic Emissions(TE or DPOAEs). Ituses an ear probe todeliver stimulus and torecord evoked OAEs.Recorded signals areevaluated automaticallyusing signal analysis toprovide robustindications of cochlearfunction and highimmunity to extraneousnoise. Additionally, thesystem includes I/Ofunctionality.	Same as K111618,K112247 andK072033 with respectto TEOAE andDPOAE.
SafetyCharacteristics	No direct electricalconnection to thepatient.	Same	Same	Same
Energy deliveredto the patient	Audible acousticstimulus to thesubject's auditorysystem.	Same	Same	Same
Energy deliveredto the patient	Audible acousticstimulus to thesubject's auditorysystem.	Same	Same	Same
Energy deliveredto the patient	Audible acoustic stimulusto 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	FunctionK111618	FunctionK112247	K072033	New device
Energy deliveredto the patient	Audible acousticstimulus to thesubject's auditorysystem.	Same	Same	Same
Mechanical safety	No movingmechanical parts incontact with thesubject	Same	Same	Same
Electrical Safetyand PerformanceStandards	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 poweredhardware (Batterytype)	Yes (RechargeableLithium Ion Battery)	No (6 V DC)	Yes (Rechargeable Lithiumpolymer)	Same as K111618
Data display	Information displayedon the AuDX screenand the PC monitorscreen for the AuDXI/O	Information displayedon computer monitorscreen.	Information displayedon the Otoport devicescreen.	Information displayedon the device's LCDscreen and can bedisplayed on acomputer monitorscreen.
Built in keys foruser interface onthe collection box	Yes; 5-keys	No	Yes	Yes, 7-keys
Computercompatibility	IBM compatible PC.	Same	Same	Same
Operating System	Windows for host PCfor AuDX I/O andutilities. No OS for theAuDX hardwaredevice.	Windows® 2000,Windows® XP,Windows® 7	Windows 2000/XP/Vistafor PC based utilities	No OS for the AuDXhardware device.
Communication withPC	RS-232 and USB	RS-232 and USB	USB	RS-232 and USB
System Design	With respect toTEOAE and DPOAE,the main stimulusgeneration and dataacquisition hardwareconnected to OAEprobe. For the AuDXI/O functionality, themain stimulusgeneration and dataacquisition hardwareconnected to OAEprobe and a personalcomputer hostingtesting software, datadisplay and userinterface.	Main stimulusgeneration and dataacquisition hardwareconnected to patientcables, transducersand personalcomputer hostingtesting software, datadisplay and userinterface.	Main stimulusgeneration and dataacquisition hardwareconnected to OAEprobe and hosting thetesting software, datadisplay and userinterface functionalitywithout a need toconnect to PC.	Main stimulusgeneration and dataacquisition hardwareconnected to OAEprobe.
	AuDX with AuDX I/O.Function	ABaer with ABaer I/OFunction		AuDX Pro
Predicate 510(k)number	K111618	K112247		New device
Uses disposable eartips (silicon and foamear tips)	Yes	Yes	Yes	Yes
Biocompatibility	Ear tip materials areclassified by ISO 10993-1 as surface-contactingdevices / limitedexposure to skin. Tests:Cytotoxicity (ISO 10993-5), Sensitization (ISO10993-10), and Irritation(ISO 10993-10)	Same	Info not available	Same
Sterility	None required	Same	Same	Same
Built-in LCD ScreenTransducers	YesBio-logic OAE Ear Probe	YesBio-logic OAE Ear Probefor OAE tests. TDH-39earphones, insertearphones, boneconductor oscillator forABR tests.	YesOtodynamics OAE earprobe	YesBio-logic OAE Ear Probe
Software andFirmware	The handheld AuDXhardware runs thefirmware written inassembly code thatcontrols the stimulusgeneration, datacollection and analysisfor OAE testing. TheAuDX I/O softwarefeature is written inC++ language andmainly provides theconvenient PC-baseduser interface andcommunicates withthe data collectionhardware.	Firmware is writtenentirely in ADSP-219xassembly language.This allows for directand efficient control ofthe DSP andassociated hardware.Software is written inMicrosoft VisualStudio C++.	Firmware controls thestimulus presentation,data collection andevaluation. Specificdevelopment languageis not available fromcompetitive productinformation.	The handheld AuDXPro hardware runsthe firmware written inassembly code thatcontrols the stimulusgeneration, datacollection andanalysis for OAEtesting.
Reports	Data files can beprinted	A single patient reportcan be printed basedon a default template.Four types of multi-patient reports areavailable (basic,extended, completeand custom).Additionally, statisticalreports can begenerated.	A single patient reportcan be printed viaOtolink accessorysoftware. There are twoprint formats: one toprint the results of asingle ear and the otherprints the results of twotests, one for each ear.	Similarly, a singlepatient report can beprinted. There are twoprint formats: one toprint the results of asingle ear and theother prints theresults of two tests,one for each ear.
Patient & TestInformationDatabase (P&TI)	No	Yes, includespredefined fields,customizable layout,edit feature, searchfeature, sort feature,form & table views,archival / copyfeature, backupfeature, repairfeature, compactfeature and importtool.	Similarly, data can betransferred to PC viaOtolink accessorysoftware.	Similarly, AuDX Pro isable to store data inand configurecommon P&TIdatabase like ABaer.
	AuDX with AuDX I/OFunction	ABaer with ABaer I/OFunction	Otodynamics Otoport	AuDX Pro
Predicate 510(k)number	K111618	K112247	K072033	New device
HearingAssessment &Tracking System(HATS)	No	Yes. The HATS utilityenables AuDX Prodata to be exported toHiTrack via ABaer.	Similarly, Otolinkaccessory softwareenables transfer of datato HiTrack.	Yes. The HATS utilityextracts data from theAuDX Pro box andenables theexportation to HiTrackvia ABaer.
Microphonefrequencyresponse	100 Hz - 10 kHz ± 3dB	Same	Info not available	Same
Microphonesensitivity (@1 kHzre 1V/Pa)	-33 dB	Same	Info not available	Same
Speaker frequencybandwidth	100 Hz - 10 kHz ± 5dB	100 Hz - 10 kHz ± 5dB	500Hz-6000Hz	100 Hz - 10 kHz ± 5dB
System Signal-to-noise ratio	-85 dB	Same	Same	Same
Speaker sensitivity	90 dB SPL (@ 1kHzre 1 VAC Drive)	92 dB re 1 VAC	Info not available	90 dB SPL (@ 1 kHzre 1 VAC Drive)
Maximum stimulusoutput	<95 dB	Same	Same	Same

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: :

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wings and tail. The eagle is facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV 1 2012

Natus Medical Incorporated c/o Mr. Timothy Karlovsky Quality and Regulatory Assurance Manager One Bio-logic Plaza Mundelein, IL 60060

Re: K122496

Trade/Device Name: AuDX Pro Otoacoustic Emissions Measurement System Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: August 15, 2012 Received: August 16, 2012

Dear Mr. Karlovsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including; but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Edmund f

Malvina B. Eydelman, M.D Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K122496 510(k) Number (if known):

Device Name: AuDX Pro Otoacoustic Emissions Measurement System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Offic f Device Evaluation (ODE)

Chr. Hein

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

Regulation Number and Section

§ 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.