HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER

K063338 · Mimosa Acoustics, Inc. · EWO · Jan 4, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K063338
• Device Name: HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
• Applicant: Mimosa Acoustics, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jan 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies. The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-to-noise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only.

Device Story

HearID+TE is an otoacoustic emission (OAE) analyzer measuring acoustic properties of the inner ear; inputs include sound pressure level, signal-to-noise ratio, and reproducibility data collected via probe; system processes these inputs within prescribed frequency bands or wideband to evaluate inner-ear functional condition; intended for use by trained personnel in clinical settings; output provides objective data to assist clinicians in diagnosing inner-ear pathologies; benefits include non-invasive assessment of cochlear function across all ages, including newborns.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Audiometer (CFR 874.1050) for OAE measurement; measures sound pressure level, signal-to-noise ratio, and reproducibility; supports frequency-specific and wideband analysis; software-based processing; intended for use by trained personnel.

Indications for Use

Indicated for all populations, including newborn infants, to characterize inner-ear status and assist in diagnosing inner-ear pathologies, assuming normal middle and outer ear function.

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

JAN 0 4 2007

Mimosa Acoustics, Inc. c/o Patricia S. Jeng, Ph.D. 60 Hazelwood Drive, Suite #209 Champaign, IL 61820

K063338 Re:

Trade/Device Name: HearID Transient-Evoked Otoacoustic Emission Analyzer (HearID+TE, T2001, and T2K) Regulation Number: CFR 874.1050

Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: October 31, 2006 Received: November 8, 2006

Dear Dr. Jeng:

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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Page 2 - Patricia S. Jeng. Ph.D.

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 vour 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/industry/support/index.html.

Sincerely yours.

M.B. Eichelman, M.D.

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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K063338

## Indications for Use 1

## Indications for Use

510(k) Number (if known):

Device Name: HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer

Indications for Use:

The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies.

The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-tonoise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only.

The HearID system comes in two versions for use with different hardware platforms.

Prescription Use X_ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONPANUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ea. An, mo

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K063338 |
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(Per 21 CFR 801.109)

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