MAICO MA42

K982723 · Bernafon-Maico, Inc. · EWO · Oct 28, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K982723
• Device Name: MAICO MA42
• Applicant: Bernafon-Maico, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Oct 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The indication for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.

Device Story

Maico MA42 is an audiometer used for detection and diagnosis of suspected hearing loss. Device operates in clinical settings; used by audiologists or trained healthcare professionals. Input involves manual control of frequency and intensity levels presented to patient via headphones or bone conduction transducers. Device transforms operator inputs into calibrated acoustic signals; output is patient response to stimuli. Healthcare provider uses patient response patterns to determine hearing thresholds and diagnose hearing impairment. Benefits include standardized assessment of auditory function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Audiometer device; class II; 21 CFR 874.1050 (Audiometer) and 874.3330 (Hearing aid, group, air-conduction). Operates via electrical signal generation for acoustic output. Form factor is a clinical diagnostic unit.

Indications for Use

Indicated for patients of any age with suspected hearing loss to facilitate detection and diagnosis.

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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Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 1998

Scott Savre Engineering Manager Bernafon-Maico, Inc. 9675 West 76th St. Eden Prairie, MN 55344 K982723 Maico MA42 Dated: August 4, 1998 Received: August 5, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO 21 CFR 874.3330/Procode: 77 KHL

Dear Mr. Savre:

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated 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 (Special Controls) or class III (Premarket Approval), 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 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 (11 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 vitn 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, phease 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/cdrh/dsmarm.html".

Sincerely yours,

William Yin

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

Enclosure

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K482723/4

Page 1 of 1

510(k) NUMBER (IF KNOWN): K982723

Maico MA 42 DEVICE NAME :

INDICATIONS FOR USE:

The indication for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.

FCA/CRH/ODE/DMC

17 AUG 80 1055 "F"

(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)

SK-58

OR

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

Tomil A. bezerom

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