ER36 Series OAE Test System

K150491 · Etymotic Research, Inc. · EWO · Mar 26, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K150491
• Device Name: ER36 Series OAE Test System
• Applicant: Etymotic Research, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Mar 26, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ER36 is a test instrument that measures otoacoustic emissions in infants, children, and adults.

Device Story

Battery-powered, hand-held, microprocessor-controlled instrument; measures otoacoustic emissions (OAEs) via distortion product (DPOAE) and transient-evoked (TEOAE) methods. Device connects via 1-meter cable to a MicroProbe inserted into the ear canal. Generates clicks/tones to elicit cochlear response; captures low-level audio-frequency sounds produced by outer hair cells. Used by clinicians to identify hearing impairment; results indicate cochlear function status. Modifications from prior version include updated electronics, ergonomic changes, Lithium-Ion battery, Bluetooth printing, and USB connectivity. Healthcare providers use output to assess hearing health and identify potential hearing loss.

Clinical Evidence

Bench testing only. Risk analysis performed per ISO 14971:2007; design verification and validation activities confirmed the modified device met performance specifications and remained substantially equivalent to the predicate.

Technological Characteristics

Battery-powered (Lithium-Ion) hand-held device; microprocessor-controlled. Includes 1-meter cable with MicroProbe and field-replaceable 9-lumen probe tip. Connectivity: Bluetooth (printing) and USB. Principle: OAE measurement (DPOAE and TEOAE).

Indications for Use

Indicated for testing cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs) via clicks or tones directed into the ear canal to assess outer hair cell viability.

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

• ERO•SCAN™ OAE Test System (K010165)

Submission Summary (Full Text)

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

Etymotic Research, Inc. % Ms. Meaghan Bailey Senior Director, Medical Devices NSF Health Sciences Medical Devices 2001 Pennsylvania Ave. NW, Suite 950 Washington, DC 20006

Re: K150491

Trade/Device Name: Er36 Series Oae Test System Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: February 25, 2015 Received: February 25, 2015

Dear Ms. Bailey:

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 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic 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) K150491

Device Name ER36 Series OAE Test System

### Indications for Use (Describe)

The ER36 Series OAE Test System is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio frequency sounds that are produced by the cochlea as part of the normal hearing process.

A vailable evidence suggests that otoacoustic emissions are generated by the cochlea's outer hair cells and that the presence of OAE's is an indication that the outer hair cells are vidence indicates that these emissions normally occur with normal hearing, or at most, mild hearing loss (usually 30-40dB HL). The majority of hearingimpaired individuals will be identified by a simple OAE test.

Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)

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

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| I. SUBMITTER | |
|------------------------|------------------------------------------------------------------------------------------------------------------------|
| Company Name: | Etymotic Research, Inc.<br>61 Martin Lane<br>Elk Grove Village, IL 60007<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person: | Meaghan Bailey, Senior Director, NSF Health Sciences |
| Date Prepared: | February 25, 2015 |
| II. DEVICE | |
| Trade Name: | ER36 Series OAE Test System |
| Common Name: | Audiometer, Otoacoustic Emissions Device |
| Classification Name: | Class II Audiometer |
| Device Classification: | Class II, 21 CFR 874.1050 |
| III. PREDICATE DEVICE | |
| Predicate Devices: | ERO•SCAN TM OAE Test System (K010165)<br>Etymotic Research, Inc.<br>Class II, 21 CFR 874.1050 |

Purpose of the Special 510(k) Premarket Notification: The ER36 is a modification of its predicate device.

## IV. DEVICE DESCRIPTION

Device Description: The ER36 Series OAE Test System is a battery powered, hand-held microprocessor-controlled instrument designed to measure otoacoustic emissions. The ER36 is connected by a 1 meter, thin flexible cable to the ER36 MicroProbe OAE Test Probe (Ear Probe). The Ear Probe incorporates a field replaceable Probe Tip (9-lumen tube) that is inserted and acoustically sealed to the test ear canal with a compliant ear tip. The ER36 provides otoacoustic emissions measurements by two methods: distortion product otoacoustic emissions (DPOAE), and transient-evoked otoacoustic emissions (TEOAE). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal hearing process.

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Modifications and enhancements from the prior device version (ER34) includes updated electronic components removal of the device internal probe, change in ergonomics and the patient/user interface (i.e., LED/LCD display, ear probe housing material, and switch change), change in the dimensions of the controller housing, battery power change (Lithium-Ion rechargeable single cell), addition of a Bluetooth wireless printing option, and addition of a USB computer connection.

## V. INDICATIONS FOR USE

| Intended Use: | The ER36 is a test instrument that measures otoacoustic<br>emissions in infants, children, and adults. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The ER36 Series is indicated for testing of cochlear<br>function in infants, children and adults by measuring<br>otoacoustic emissions (OAEs). The OAEs are generated by<br>a series of clicks that are directed into the ear canal.<br><br>Otoacoustic emissions are low level audio-frequency<br>sounds that are produced by the cochlea as part of the<br>normal-hearing process. Available evidence suggests that<br>otoacoustic emissions are generated by the cochlea's outer<br>hair cells and that the presence of OAEs is an indication<br>that the outer hair cells are viable. Clinical evidence<br>indicates that these emissions normally occur with normal<br>hearing, or at most, mild hearing loss (usually 30-40 dB<br>HL). The majority of hearing-impaired individuals will be<br>identified by a simple OAE test. |

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The product has the same intended use, indications for use, and principle of operation as the ERO•SCANTM OAE Test System (K010165). Modifications to the device do not raise new or different questions of safety or effectiveness for the device's intended use. The results of risk analysis and design verification and validation activities provide evidence that the device is as safe and effective as its predicate. This evidence therefore demonstrates that the ER36 is substantially equivalent to its predicate device, ERO®SCANTM OAE Test System.

## VII. PERFORMANCE DATA

The risk analysis method used to assess the impact of the modifications was ISO 14971:2007. According to the results of the risk analysis, the residual risks of the device were deemed acceptable in relation to device benefits. Design verification activities were performed to ensure the modified device was substantially equivalent to the predicate device and that it met performance specifications; this testing was performed on the basis of the risk analysis and per device design controls.

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Conclusion: The ER36 utilizes the same technology and has the same indications for use as the cited predicate device (21 CFR 807.92(a)(3)), and is therefore substantially equivalent.