TEOAE25

K030016 · Interacoustics A/S, Assens · EWO · Mar 28, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K030016
• Device Name: TEOAE25
• Applicant: Interacoustics A/S, Assens
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

TEOAE25 is an accessory to the EP15 or EP25 platform and provides the ability to test the cochlea functions of infants, children and adults in hospitals, nurseries, ENT clinics or audiology offices. It measures the amount of otoacoustic emission (OAE) present in the ear after a stimulus, and it allows a trained operator to get objective information about the cochlea function.

Device Story

TEOAE25 functions as an accessory module for the EP15 or EP25 platform; designed for clinical use by trained operators (audiologists, ENT staff). Device delivers acoustic stimuli to the ear canal and records resulting otoacoustic emissions (OAEs). System processes these signals to provide objective data regarding cochlear function. Used in hospitals, nurseries, and clinics to assess hearing health across all age groups. Output allows clinicians to evaluate cochlear integrity and inform diagnostic decisions.

Clinical Evidence

No clinical data provided; device relies on established principles of otoacoustic emission measurement.

Technological Characteristics

Accessory module for EP15/EP25 platforms; utilizes acoustic stimulus delivery and signal acquisition for OAE measurement. Operates as an audiometer (21 CFR 874.1050).

Indications for Use

Indicated for testing cochlear function in infants, children, and adults in clinical settings (hospitals, nurseries, ENT clinics, audiology offices).

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Interacoustics A/S, Assens c/o Daniel Eggan Manager of Regulatory Affairs/OA Interacoustics USA 9675 West 76th Street Eden Prairie, MN 55344

MAR 2 8 2003

Re: K030016

Trade/Device Name: TEOAE25 Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: November 4, 2002 Received: January 2, 2003

Dear Mr. Eggan:

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.

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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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/cdrh/dsma/dsmamain.html

Sincerely yours,

A helyi korenthal

A. Ralph Rosenthal, 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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## Section A

## Indications for Use Statement

Applicant: Interacoustics A/S, Assens KO30016 510(k) Number (if known): __ Device Name: TEOAE25

## Indications for Use

TEOAE25 is an accessory to the EP15 or EP25 platform and provides the ability to test the cochlea functions of infants, children and adults in hospitals, nurseries, ENT clinics or audiology offices.

It measures the amount of otoacoustic emission (OAE) present in the ear after a stimulus, and it allows a trained operator to get objective information about the cochlea function.

Karen H Boken

Nose and Throat

510(k) Number L030116

Prescription Use . (Per 21 CFR 801.109)