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.

Available 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 viable. Clinical evidence 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.

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.

AI/ML Overview

This document describes the ER36 Series OAE Test System, an audiometer device for measuring otoacoustic emissions. However, it does not include acceptance criteria or the details of a study demonstrating its performance against those criteria. The provided text is a 510(k) premarket notification summary from the FDA, which focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance efficacy data from clinical trials.

The document discusses:

Substantial Equivalence: The primary goal of this submission is to demonstrate that the ER36 Series OAE Test System is substantially equivalent to a legally marketed predicate device (ERO•SCAN™ OAE Test System, K010165). This means it has the same intended use, indications for use, and principle of operation, and that modifications do not raise new questions of safety or effectiveness.
Modifications: It lists modifications from a prior device version (ER34), including updated electronic components, ergonomic changes, battery power change, and addition of Bluetooth and USB connectivity.
Risk Analysis: A risk analysis was performed according to ISO 14971:2007, and residual risks were deemed acceptable.
Design Verification: 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 based on risk analysis and design controls.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it is not present in the provided text. The document states that "Design verification activities were performed... that it met performance specifications," but it does not detail those specifications (acceptance criteria) or the specific results of the studies used to demonstrate compliance.

To answer your request, I would need a different document that specifically outlines the performance study and its results to demonstrate how the device meets predefined acceptance criteria.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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.61 Martin LaneElk Grove Village, IL 60007Tel: (847) 228-0006Fax: (847) 228-6836
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)Etymotic Research, Inc.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 otoacousticemissions in infants, children, and adults.
Indications for Use:	The ER36 Series is indicated for testing of cochlearfunction in infants, children and adults by measuringotoacoustic emissions (OAEs). The OAEs are generated bya series of clicks that are directed into the ear canal.Otoacoustic emissions are low level audio-frequencysounds that are produced by the cochlea as part of thenormal-hearing process. Available evidence suggests thatotoacoustic emissions are generated by the cochlea's outerhair cells and that the presence of OAEs is an indicationthat the outer hair cells are viable. Clinical evidenceindicates that these emissions normally occur with normalhearing, or at most, mild hearing loss (usually 30-40 dBHL). The majority of hearing-impaired individuals will beidentified by a simple OAE test.

Intended Use:

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

Indications for Use:

The ER36 Series is indicated for testing of cochlearfunction in infants, children and adults by measuringotoacoustic emissions (OAEs). The OAEs are generated bya series of clicks that are directed into the ear canal.Otoacoustic emissions are low level audio-frequencysounds that are produced by the cochlea as part of thenormal-hearing process. Available evidence suggests thatotoacoustic emissions are generated by the cochlea's outerhair cells and that the presence of OAEs is an indicationthat the outer hair cells are viable. Clinical evidenceindicates that these emissions normally occur with normalhearing, or at most, mild hearing loss (usually 30-40 dBHL). The majority of hearing-impaired individuals will beidentified 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.

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.