A BAER WITH ABAER I/O FUNCTION

K112247 · Natus Medical Incorporated · EWO · Apr 2, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K112247
• Device Name: A BAER WITH ABAER I/O FUNCTION
• Applicant: Natus Medical Incorporated
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Apr 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The 'ABaer System with ABaer 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

ABaer system performs automated auditory brainstem response (ABR) and otoacoustic emissions (OAE) screening. ABR input: electrical activity from three scalp electrodes following click stimuli. OAE input: acoustic signals in ear canal recorded via miniature microphone. ABaer I/O software option adds DPOAE Input/Output testing; measures DPOAE response across varying stimulus intensities/frequencies. System processes data via Point Optimized Variance Ratio (POVR) algorithm for ABR; calculates reproducibility, noise floor, and amplitude for OAE. Output: graphical representation of stimulus level vs. DPOAE level, plus Pass/Refer recommendations. Used by trained healthcare professionals in clinical settings. Output assists clinicians in evaluating cochlear outer hair cell function; aids in identifying hearing status in patients unable to provide reliable behavioral responses.

Clinical Evidence

Bench testing only. Design verification and validation were performed to confirm the ABaer with ABaer I/O Function meets performance specifications and demonstrates equivalence to predicate devices. No clinical study data provided.

Technological Characteristics

Windows-based software application running on PC hardware. Components include data collection box, insert earphones, headphones, OAE probe, and electrodes. Sensing: acoustic transducers for stimuli, electrodes for ABR, miniature microphone for OAE. Connectivity: USB. Algorithm: Point Optimized Variance Ratio (POVR) for ABR signal optimization.

Indications for Use

Indicated for patients of all ages (newborns to geriatric) requiring cochlear function assessment. Especially indicated for individuals where behavioral testing is unreliable, including 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

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

Submission Summary (Full Text)

{0}------------------------------------------------

K112247

APR - 2 2012

## 510(k) SUMMARY

Manufacturer's Name:

Natus Medical Incorporated One Bio-logic Plaza Mundelein, IL 60060

Corresponding Official:

Telephone Number: Fax Number:

Summary Date:

Trade Name:

**Common or Usual Name:**

Classification Name and Number:

Predicate Devices:

Device Description:

Don Williams Vice President and General Manager Natus Medical Incorporated One Bio-logic Plaza Mundelein, IL 60060 800.323.8326 ext. 5424 847.949.8615

March 28, 2012

ABaer with ABaer I/O Function

Common or Usual Name: Audiometer and Evoked response auditory stimulator

Audiometer 21 CFR 874.1050, Product Code: EWO

Evoked response auditory stimulator 21 CFR 882.1900 Product Code: GWJ

K021801 ABaer Cub with Automated OAE and ABR

K964132 Bio-logic Scout and Scout Sport Otoacoustic Emissions (OAE) Test Instruments with TEOAE and DPOAE Software, incorporating the modifications of Automated Input / Output Software Functions

K072033 Otodynamics Otoport

The ABaer I/O Function is a Windows® based software application for use with the ABaer Hearing Screening System. The ABaer I/O software option enables the ABaer device user to perform DPOAE Input/Output (I/O) testing at different test frequencies, frequency ratios and intensity levels in addition to the ABR and OAE based hearing screening functions. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level provides an effective way for the

{1}------------------------------------------------

Intended Use:

Technological Characteristics: user to view and evaluate stimulus level-sensitive information about DPOAE responses.

The 'ABaer System with ABaer 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 ABaer Hearing Screening System (HSS) performs an automated auditory evoked response (ABaer) screening and/or an automated otoacoustic emissions (AOAE) screening. The automated auditory brainstem response test (ABaer) involves placement of three recording electrodes on an infant's head. The electrodes record electrical activity generated by the auditory nervous system that results from the presentation of a click stimulus into the patient's ear via acoustic transducers (i.e. insert earphones, headphones, OAE probe, acoustic ear couplers). The system collects and averages evoked potential data in order to perform ABR based screening, recording and analysis functions, provides one channel of data recording, and includes the Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the automated screening function and enhancing speed of test completion in the same manner as in the predicate device (K021801). The device presents the resulting POVR score and a Pass/Refer recommendation to the user.

With respect to the ABR based testing, the ABaer with ABaer I/O Function is equivalent to the predicate device cleared under K021801.

The automated otoacoustic emissions (AOAE) screening functionality of the ABaer system involves producing controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions that are generated by the inner ear as a result of normal hearing processes. The ABaer device performs both distortion product otoacoustic emissions (DPOAE) tests and transient evoked otoacoustic emissions (TEOAE) tests.

{2}------------------------------------------------

The OAE stimuli are generated 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, averages and analyzes data samples until specified measurement and test 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 the test protocol parameters and measured OAE parameters.

With respect to TEOAE and DPOAE testing, the ABaer with ABaer I/O Function is equivalent to the devices cleared under K021801. K964132. and K072033.

The ABaer I/O is a software option to be used in conjunction with the ABaer system. The standard DPOAE test measures otoacoustic response to a series of frequency-pairs of tones, varving the frequency while keeping the level or intensity of the stimulus tones at a constant level. The ABaer I/O software option enables the ABaer 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 ABaer with ABaer 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 ABaer with ABaer I/O Function meets its performance specifications and demonstrates equivalence to the functionalities present in the respective predicate devices.

{3}------------------------------------------------

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

# Components:

| Hardware | |
|----------------|-----------------------------------------------------|
| 580-ABAER2 | ABaer Data Collection Box |
| 580-SINABR-008 | Insert Earphones |
| 206920 | Halo Adaptors & tubes |
| 580-MEPTDH-125 | Headphones |
| 301663 | Alligator Clips (3) |
| 580-PROAE3 | OAE Style Probe |
| 541-ABRC10-008 | Patient Cable - 3 inputs |
| 541-USB001 | USB Cable (ABaer & Printer) |
| 520-PSVDC | Power Supply for ABaer module |
| 540-LINECD-012 | Power Cord - 12 inch |
| 001308 | Seiko Smart Label Printer |
| 541-SEKBLE | Printer Serial Cable |
| 520-SEK120 | Printer Power Supply |
| 520-AMPS01 | Isolation Transformer - 3 outlet (laptop only) |
| 520-SWBXFS | Isolation Transformer - 6 outlet (touchscreen only) |
| 541-CORD12 | Power Cord for Isolation Transformer |
| 541-TSTCBL | Loop Test Cable |
| 001771 | Panel PC |
| 001316 | Notebook PC |
| Software | |
| 008634 | ABaer Software |
| 008164 | ABaer I/O Function Software |

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Natus Medical Inc. c/o Mr. Don Williams Vice President and General Manager One Bio-Logic Plaza Mundelein, IL 60060

Re: K112247

Trade/Device Name: ABaer with ABaer I/O Function Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: February 28, 2012 Received: February 29, 2012

Dear Mr. Williams:

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.

APR - 2 2012

{5}------------------------------------------------

## Page 2 - Mr. Don Williams

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Makin R.E. Aldous, MD

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

Enclosure

{6}------------------------------------------------

i 12 247

### Indications for Use

# 510(k) Number (if known): KIL2247

### Device Name: ABaer with ABaer I/O Function

#### Indications for Use:

The Hearing Screening System (HSS) ABaer performs an automated brainstem auditory evoked response (ABaer) screening and/or an automated otoacoustic emissions (AOAE) screening. The automated auditory brainstem response test (AABR) involves placement of three recording electrodes on an infant's head. The electrodes record the electrical activity generated by the auditory nervous system that result from presentation of a click stimulus into the ear. The automated otoacoustic emissions (AOAE) screening involves producing controlled acoustic signals in the ear canal and measuring the resulting evoked otoacoustic emissions that are generated by the inner ear as a result of normal hearing processes. The ABaer device performs both distortion product otoacoustic emissions (DPOAE) tests and transient evoked otoacoustic emissions (TEOAE) tests.

The ABaer I/O is a software option to be used in conjunction with the ABaer 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 ABaer I/O software option enables the ABaer device user to perform DPOAE testing at different stimulus intensities in order to obtain the 'DPOAE Input / Output (!/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 presented versus measured DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE responses. DPOAE threshold is the lowest stimulus intensity level which produces DPOAE response amplitude that is distinguishable from the level of system distortion and from the noise floor. DPOAE threshold is expressed in much of the published literature as the lowest intensity of the F2 stimulus that generates a clear DPOAE response. DPOAE threshold does not equate to and should not be confused with audiometric and auditory threshold. Whereas auditory threshold measures assess the integrity of the entire auditory system from outer ear to cortex, DPOAE threshold measures, which the user can interpret from the DPOAE I/O functions, are limited to assessment of outer hair cell function in the cochlea only.

The 'ABaer System with ABaer 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.

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)T. Neik

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)

Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number K112247

Prescription Use . (Per 21 CFR 801.109)