COCHLEA-SCAN / COCHLEA-SCAN PLUS

K061744 · Bio-Logic Systems Corp. · EWO · Sep 15, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K061744
• Device Name: COCHLEA-SCAN / COCHLEA-SCAN PLUS
• Applicant: Bio-Logic Systems Corp.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Sep 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs. The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses. The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants. The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).

Device Story

Hand-held examination system using Otoacoustic Emissions (OAE) technology; inputs include OAE signals via miniature probe and pure tone audiometry via standard headphones. Device employs automated OAE measurement and signal statistics to evaluate hearing; includes automated hearing threshold estimation algorithm. Used by trained personnel in medical or school environments to screen and diagnose hearing disorders. Output consists of hearing assessment data and threshold estimations; assists clinicians in identifying hearing loss and fitting conventional hearing aids. Does not provide data for cochlear or middle ear implant fitting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance similarities to the predicate device.

Technological Characteristics

Hand-held audiometer/OAE system. Features miniature probe (identical to predicate) and standard audiometry headphones with calibration data in customized connector. Employs OAE sensing and pure tone audiometry. Software includes automated hearing threshold estimation algorithm. Powered via docking station.

Indications for Use

Indicated for automated objective hearing assessment, diagnostic hearing evaluations, and hearing screening in newborns, children, and adults, including geriatric patients. Used to assist in the diagnosis of middle ear and cochlear hearing losses and the selection/fitting of conventional hearing aids.

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

• Fischer-Zoth, model Echo-Screen (K013977)

Submission Summary (Full Text)

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KC6174YY

## 510(k) Summary of Safety and Effectiveness

| | 510(k) Summary of Safety and Effectiveness<br>as required by section 807.92 (c) | SEP 15 2006 |
|-------------------------------------------|---------------------------------------------------------------------------------------------|-------------|
| Submitters Name and Address: | Bio-logic Systems Corp.,<br>(a Natus company)<br>One Bio-logic Plaza<br>Mundelein, IL 60060 | |
| Contact Person & Phone: | Mr. Norman Brunner<br>[phone] ext. -224 | |
| Date Summary Prepared: | May 05th, 2006 | |
| Device Name:<br>Proprietary / Trade name: | Classification name - Audiometer, EWO<br>Cochlea-Scan / Cochlea-Scan Plus | |
| Predicate Device: | Fischer-Zoth, model Echo-Screen: 510(k) K013977 | |

Device description:

Cochlea-Scan is a hand-held examination system based on Otoacoustic Emissions (OAE) technology. Identical techniques are used - among others - on Fischer-Zoth model Echo-Screen. The Cochlea-Scan product family is designed easy to use and employs automated OAE. The measurement flow is menu quided and the evaluation is based upon signal statistics. The Cochlea-Scan devices are designed for trained personnel in a medical or school environment to examine hearing in newborns through adults, including geriatric patients. With its built-in automated hearing threshold estimation algorithm the device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present and in case of hearing loss proposes an estimation of the hearing threshold in a given frequency range. Additionally Cochlea-Scan is equipped with a standard pure tone audiometer.

Intended use:

- The Cochlea Scan is intended for use in automated objective hearing assessment using 1. distortion product OAEs.
- The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the 2. diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses.
- The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of 3. conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.
- The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE 4. module).

#### Technological Characteristics:

- miniature probe, easy to apply even for premature infants, identical Probe: to the probe used on the predicate device Echo-Screen -Headphone: standard audiometry headphone with calibration data stored in customized connector

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Docking station label (50 mm x 20 mm):

| Docking station | FZ |
|-----------------|----|
|-----------------|----|

| USE ONLY CHARGER | FW7206/09 |
|------------------|-----------|
|------------------|-----------|

Follow safety hints!

Sicherheitshinweise beachten!

Suivez attentivement les instrucions d'usage!

Seguire le istruzioni per la sicurezza!

## Operation manual

See Appendix A

## Advertising and Promotional Materials

Bio-logic intends to promote and market the Cochlea-Scan in professional and trade publications, through marketing materials, and at trade shows and professional organization meetings. The advertising and promotional materials will incorporate the product design, product specifications, and product claims as described in this 510(k) submission.

All advertising and promotional materials will comply with the following statement of intended use:

The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs.

The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses.

The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.

The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The symbol is stylized and modern, representing the department's mission and values.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FP 1 5 2006

Bio-Logic Systems Corp. c/o Mr. Norman Brunner One Biologic Plaza Mundelein, IL 60060-3700

Re: K061744

Trade/Device Name: Cochlea-Scan/Cochlea-Scan Plus Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: August 18, 2006 Received: August 21, 2006

Dear Mr. Brunner:

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 r va may, atere, which 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 11 your device 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 r lease be actives mark 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 – Mr. Norman Brunner

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/industry/support/index.html.

Sincerely yours,

M.B. Egelman SimMD

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 STATEMENT

#### K061744 510(k) Number (if known):

## Device Name: Cochlea Scan.

#### Indications For Use:

- 1. The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs.
- 2 The Cochlea Scan is intended for use in diagnostic hearing evaluations and The Cochiea Soan is finchuod for able hearing disorders by means of OAEs and/or assistance in the alaghous of possorders include middle ear and cochlear hearing losses.
- The results of the Ocenica ads. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.
- 4. The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

TVC

(Unvision Sign-C Division of Ophthalmic E Nose and Throat Devis 510(k) Numbe

Prescription Use ✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)

510(k) CochleaScan.doc

(Per 21 CFR 801.109)