AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)

K982566 · Bar - Advanced Control Systems , Ltd. · EWO · Oct 21, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K982566
• Device Name: AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
• Applicant: Bar - Advanced Control Systems , Ltd.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The ASAM device is an automated audiometer intended for use in conducting hearing threshold evaluations, by the subject without intervention of a skilled professional.

Device Story

The Automatic Self-Operated Screening Audiometer (ASAM) is an automated device designed for self-administered hearing threshold testing. The device functions by presenting auditory stimuli to the user, who responds to the signals to determine hearing thresholds. It is intended for use by the subject independently, eliminating the need for a skilled professional during the evaluation process. The output provides hearing threshold data, which assists in screening for hearing loss. The device is designed for clinical or screening environments where self-testing is appropriate.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device intent and classification.

Technological Characteristics

Automated audiometer; self-operated; electronic signal generation for hearing threshold testing. Class II device (21 CFR 874.1050, Procode 77 EWO).

Indications for Use

Indicated for individuals requiring hearing threshold evaluations; intended for self-administration without professional intervention.

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

OCT 21 1998

Bar - Advanced Control Systems Ltd. c/o A Stein-Regulatory Affairs Consulting Ahava Stein P.O. Box 454 Ginot Shomron, 44853 ISRAEL

## K982566

Re:

Automatic Self-Operated Screening Audiometer Device July 19, 1998 Dated: Received: July 23, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

Dear Mr. Stein:

We have reviewed your Sections \$10(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for usestated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/odrf/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

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| 510(k) Number (if known): | K942566 |
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Device Name: Automatic Self-Operated Screening Audiometer (ASAM) Device

The ASAM device is an automated audiometer intended for use in Indications for use: conducting hearing threshold evaluations, by the subject without intervention of a skilled professional. if

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use V (Per 21 C.F.R. 801.109)

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OR

Over-The-Counter Use (Optional Format 1-2-96)

Urintle. Legman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number