AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION

K111618 · Natus Medical Incorporated · EWO · Dec 28, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K111618
• Device Name: AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
• Applicant: Natus Medical Incorporated
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Dec 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The 'AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function" is indicated for use when it is necessary for a trained health care professional to measure or determine 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

AuDX Otoacoustic Emissions Measurement System measures cochlear function via TEOAE and DPOAE testing. System uses miniature receivers and microphones in a Bio-logic OAE probe to deliver acoustic stimuli to the ear canal and record resulting emissions. Software collects/averages data samples; calculates TEOAE reproducibility/noise floor and DPOAE/noise floor amplitudes. AuDX I/O software option enables DPOAE testing at varying stimulus intensities to generate Input/Output functions. Output is graphical representation of stimulus level vs. DPOAE level. Used in clinical/screening environments by trained personnel (nurses, technicians, volunteers) for screening or audiologists/physicians for diagnostic assessment. Automated pass/refer recommendations provided for screening; diagnostic data used by clinicians to assess cochlear function, aid diagnosis, and manage hearing disorders.

Clinical Evidence

Bench testing only. Design verification and validation performed to confirm performance specifications and equivalence to predicate automated I/O functions. No clinical study data presented.

Technological Characteristics

Windows-based software application; hardware includes miniature receivers and microphones in Bio-logic OAE probe. Performs TEOAE and DPOAE testing. Connectivity via AuDX system. Software-based signal processing for data averaging and amplitude calculation. Automated pass/refer algorithm based on user-defined or default protocols.

Indications for Use

Indicated for patients of all ages (newborns to geriatric) to measure cochlear function. Especially for individuals where behavioral testing is unreliable (infants, young children, cognitively impaired). Used for hearing screening (by trained personnel) and diagnostic assessment (by audiologists/physicians).

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

• ABaer Cub with Automated OAE and ABR (K021801)
• Bio-logic Scout and Scout Sport Otoacoustic Emissions (OAE) Test Instruments (K964132)
• Sport / AuDX OAE Test Instrument with Bio-logic Ear Probe (K974076)
• Otodynamics Otoport (K072033)

Submission Summary (Full Text)

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## natus.

## 510(k) SUMMARY

DEC 2 8 2011

| Manufacturer's Name: | Natus Medical Incorporated<br>One Bio-logic Plaza<br>Mundelein, IL 60060 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Martha M. Kadas<br>Director Quality Assurance and Regulatory Affairs<br>Natus Medical Incorporated<br>One Bio-logic Plaza<br>Mundelein, IL 60060 |
| Telephone Number:<br>Fax Number: | 847.573.5409<br>847.949.8615 |
| Summary Date: | May 31, 2011 |
| Trade Name: | AuDX Otoacoustic Emissions Measurement System with<br>AuDX I/O Function |
| Common or Usual Name: | Audiometer |
| Classification Name<br>and Number: | Audiometer 21 CFR 874.1050, Product Code: EWO |
| Predicate Devices: | K021801 ABaer Cub with Automated OAE and ABR<br>K964132 Bio-logic Scout and Scout Sport Otoacoustic<br>Emissions (OAE) Test Instruments with TEOAE and DPOAE<br>Software, incorporating the modifications of Automated<br>Input / Output Software Functions<br>K974076 Sport / AuDX OAE Test Instrument with Bio-logic<br>Ear Probe<br>K072033 Otodynamics Otoport |
| Device Description: | The AuDX I/O Function is a Windows® based software<br>application for use with the AuDX Otoacoustic Emissions<br>Measurement System. The AuDX I/O software enables the<br>AuDX device user to perform DPOAE testing at different test<br>frequencies, frequency ratios and intensity levels. The<br>graphical representation of the test results in the form of<br>stimulus level presented versus measured DPOAE level<br>provides an effective way for the user to view and evaluate |

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Intended Use:

Technological Characteristics: stimulus level-sensitive information about DPOAE responses.

The 'AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function" is indicated for use when it is necessary for a trained health care professional to measure or determine 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.

The AuDX 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 qenerated by the inner ear as a result of normal hearing process. The stimuli are presented via miniature receivers and the sounds in the external ear canal are 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 at the end of the test automatically based on user defined custom protocols or default test protocols and measured OAE test parameters.

With respect to TEOAE and DPOAE testing, the AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function is equivalent to the devices cleared under K021801, K964132, K974076, and K072033.

The AuDX I/O is a software option to be used in coniunction with the AuDX system. The standard DPOAE test measures otoacoustic response to a series of frequency-pairs of tones. varying the frequency while keeping the level or intensity of the stimulus tones at a constant level. The AuDX I/O

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software option enables the AuDX device user to perform DPOAE testing at different stimulus intensities in order to obtain the 'DPOAE Input / Output (I/O) function' for user defined test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level vs. DPOAE level provides an effective way for the user to view and evaluate stimulus levelsensitive information about DPOAE response.

With respect to DPOAE I/O function, the AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function is equivalent to the automated Input / Output Software functions present in the Scout and Scout Sport Otoacoustic Emissions (OAE) Test Instruments.

Nonclinical Tests: Design verification and validation were performed to assure that the AuDX I/O Function meets its performance specifications and demonstrates equivalence to the Automated I/O function present in the Scout and Scout Sport OAE Test Instruments.

> The verification and validation summary report and risk analysis documentation provided in this 510(k) support the conclusion that the AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function is safe and effective.

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

Natus Medical Incorporated c/o Martha M. Kadas Director Quality Assurance and Regulatory Affairs One Bio-logic Plaza Mundelein, IL 60060

DEC 2 8 2011

Re: K111618

Trade/Device Name: AuDX Otoacoustic Emissions Measurement System with

AuDX I/O Function Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: December 1, 2011 Received: December 2, 2011

Dear Ms. Kadas:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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, de nees may been rout do not require approval of a premarket approval application (PMA). and Coometic . Ior ( 100 ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tourmaly, moreleve, mains 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 addition. "Tease noter u, 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Aras Intactes and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFR Part 807); labeling (21 CFR 803); good manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing proctice required as set device-related adverse evenis) (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 If you desire specific advice for your device on our nocently offices/ucm II \$80.htm for go to http://www.lua.gov/Abound717 Center3011 (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office in (21 CEF) Rest the Center for Devices and Radionegroun Ireann's (SS) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = note the regulation entined, "Misoranding of reference to presents under the MDR regulation (21 CFR Part 803), please go to

CFK Part 803), picase go to IIIp://www.rda.governman.governments/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain onlier general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Elenm

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function

Indications for Use:

The AuDX Otoacoustic Emissions Measurement System produces controlled acoustic signals in the ear The RdDA Oloastic Emissions would onearen one on the emissions (OAEs) that are generated by the outer canal and freasures the result of normal peripheral hearing processes. The AuDX device performs half tells of the mirer ear as a roour of normal pennitian product otoacoustic emissions (DPOAE) tests that can be utilized in hearing screening and diagnostic test environments. The AuDX I/O (OPOAL) leasts that can bo dailibu in houring and to be used in conjunction with is a solware option intended to provise ac online enables the AuDX device user to perform DPOAE the AdDA system. The AuDX in order to obtain the 'DPOAE Input / Output (I/O) function' at testing at annular interestion the same intensity levels. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level at each tested frequency results in the form of ouring of of economiand evaluate stimulus level-sensitive information about DPOAE responses.

As an OAE based screening tool, AuDX is indicated for use by any personnel (nurses, technicians, AS an OAL based screening tool, HBA its illerice for the purpose of performing an objective, automated volunteers) who are trained to opity passirefer result requiring no further clinical interpretation. physiorogic screening moader min pacer and the device is indicated for use by traned Adultionally, as a tool that our provide allegricans) to further assess cochlear function for the purpose of nealin care professionals (addiologists, priyoldate) to farthol information may be obtained by viewing the diagriusis and treatment of nouning disorations that and by obtaining the DPOAE I/O functions.

The device can be used for patients of all ages, from newborn infants through adults, to include gerinatic r rie device on be about to patient of the especially indicated for use in testing individuals for whom patichts. The viououdly children isble, such as infants, young children, and cognitively impaired adults.

Shullan Ray

(Division Sign-Off)
Division of Ophthalmic, Neurological and

K111618

510(k) Number

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, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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