MAICO MA52

K971080 · Bernafon-Maico, Inc. · EWO · Jun 6, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971080
• Device Name: MAICO MA52
• Applicant: Bernafon-Maico, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jun 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

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

Device Story

The Maico MA52 is an audiometer used by clinicians for the detection and diagnosis of suspected hearing loss. It functions by generating and presenting controlled acoustic stimuli to a patient, who typically responds to indicate perception. The device is operated by healthcare professionals in clinical settings to assess auditory function. The output, consisting of hearing threshold measurements, allows the clinician to evaluate hearing sensitivity, identify potential hearing impairments, and guide subsequent clinical decision-making or treatment planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Audiometer device; 21 CFR 874.1050; Class II; Procode 77 EWO.

Indications for Use

Indicated for the detection and diagnosis of suspected hearing loss in patients of all ages.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN - 6 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Scott Savre
Engineering Manager
Bernafon-Maico, Inc.
9675 West 76th Street
Eden Prairie, MN 55344

Re: K971080
Maico MA52
Dated: March 21, 1997
Received: March 25, 1997
Regulatory class: II
21 CFR 874.1050/Procode: 77 EWO

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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Page 1 of 1

510(k) Number (if known): K971080

Device Name: Maico MA52

Indications For Use:

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

(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)

OR

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

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971080

$$S_k = S_{k0},$$