ER35 ERO-SCAN PRO HEARING TEST SYSTEM

K070880 · Etymotic Research, Inc. · EWO · Jun 7, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K070880
• Device Name: ER35 ERO-SCAN PRO HEARING TEST SYSTEM
• Applicant: Etymotic Research, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jun 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ER35 is intended to be a test instrument that measures otoacoustic emissions and tympanic membrane performance (tympanometry).

Device Story

ER35 ERO-SCAN Pro is a microprocessor-controlled instrument for screening otoacoustic emissions and tympanic membrane performance (tympanometry). Device measures auditory function in infants, children, and adults. Input data consists of acoustic signals for OAE and pressure/impedance measurements for tympanometry. Device processes these inputs to assess cochlear and middle ear status. Output is displayed on a graphic LCD, stored in memory, and can be printed or transferred to a computer. Used in clinical settings by healthcare professionals to assist in hearing assessment and diagnostic decision-making. Benefits include objective, non-invasive screening of auditory health.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and compliance with established performance standards.

Technological Characteristics

Microprocessor-controlled audiometer and impedance tester. Complies with ANSI S3.39-1987, IEC 60645-5, and ANSI S3.6-2004. Features graphic LCD, internal memory, and printer/computer connectivity. Materials and construction techniques are standard for hearing devices.

Indications for Use

Indicated for testing cochlear and middle ear function in infants, children, and adults via otoacoustic emissions (OAEs) and tympanometry.

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 (K980533, K010165)
• Interacoustics AT235 Impedance Audiometer (K994254)

Submission Summary (Full Text)

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# K070880

# Traditional 510(k) Premarket Notification ER35 ERO-SCAN Pro Hearing Test System

JUN - 7 2007

#### 3.0 510(K) SUMMARY

| Submission Date: | March 30, 2000 |
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# Submitter Information:

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| Company Name: | Etymotic Research, Inc. |
|------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Company Address: | Etymotic Research, Inc.<br>61 Martin Lane<br>Elk Grove Village, IL 60007 |
| Contact Person: | Steve Iseberg<br>Manager of Instrumentation Products<br>Etymotic Research, Inc.<br>Tel: [phone]<br>Fax: [phone] |

[e-mail]

# Device Information:

| Trade Name: | ER35 ERO-SCAN Pro Hearing Test System |
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| Common Name: | ER35 ERO-SCAN Pro (ER35) |
| Classification Name: | Audiometer and Auditory Impedance Tester |
| Device Class: | Class II, 510(k) exempt, 21 CFR 874.1050<br>Class II, 21 CFR 874.1090 |
| Predicate Devices: | ERO-SCAN OAE Test System (K980533, K010165)<br>Etymotic Research, Inc.<br>Class II, 510(k) exempt |
| | Interacoustics AT235 Impedance Audiometer (K994254)<br>International Distributors of Electronics for Medicine, Inc.<br>(IDEM)<br>Class II |
| Device Description: | The ER35 is a microprocessor-controlled instrument<br>designed to screen otoacoustic emissions and tympanic<br>membrane performance (tympanometry). Test information<br>is stored in memory, displayed on a graphic LCD, and can<br>be printed by a dot matrix printer or stored on a computer.<br>The product is manufactured and delivered completely |

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| assembled to the retailer using materials and techniques<br>widely used by manufacturers of hearing devices | |
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| Intended Use: | The ER35 is intended to be a test instrument that measures<br>otoacoustic emissions and tympanic membrane<br>performance (tympanometry). |
| Indications for Use: | The ER35 ERO-SCAN Pro Hearing Test System (ER35) is<br>indicated for testing of cochlear and middle ear function in<br>infants, children, and adults by measuring otoacoustic<br>emissions (OAEs) and tympanometry. |
| Comparison to Predicate Device: | |
| | All device parameters and patient contacting materials are<br>the same for both the product which is the subject of this<br>510(k) and the predicate devices. In a few areas, the ER35<br>has reduced parameter ranges than the predicate devices. |
| Conclusion: | The ER35 utilizes the same technology and has the same<br>intended use as the cited predicate devices, and is therefore<br>substantially equivalent (21 CFR 807.92(a)(3)). |
| Performance Standards: | The ER35 is in compliance with the following performance<br>and safety standards: Specifications for Instruments to<br>Measure Aural Impedance and Admittance (Aural Acoustic<br>Immittance) (ANSI S3.39-1987), American National<br>Standards Institute, New York, 1996.; Instruments for the<br>Measurement of Aural Acoustic Impedance / Admittance<br>(IEC 60645-5), International Electrotechnical Commission,<br>Geneva, 2004; and Specification for Audiometers<br>(Dental/ENT) (ANSI S3.6-2004), American National<br>Standards Institute, New York, 2004. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Etymotic Research, Inc. c/o Campbell L. Tuskey Becker & Associates Consulting, Inc. 2001 Pennsylvania Avenue NW, Suite 950 Washington, DC 20006

JUN -7 2007

Re: K070880

Trade/Device Name: ER35 ERO-SCAN Pro Hearing Test System Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, ETY Dated: May 18, 2007 Received: May 21, 2007

Dear Ms. Tuskey:

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 for association 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). and Coometre Fros ( 100 ) 100 ) 100 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); 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.

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# Page 2- Ms. Campbell L. Tuskey

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

MB Egelman SiMD

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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K070880

Traditional 510(k) Premarket Notification ER35 ERO-SCAN Pro Hearing Test System Etymotic Research, Inc. Page 5

### STATEMENT OF INDICATIONS FOR USE 2.0

510(k) Number (if known): K 070880

Device Name:

ER35 ERO-SCAN Pro Hearing Test System

Indications for Use:

The ER35 ERO-SCAN Pro Hearing Test System (ER35) is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs) and tympanometry.

Prescription Use X (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 OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

K020880

Page 1 of 1

Prescription Use
(Per 21 CFR 801.109)