HORTMANN AMDIS-OAE OAE ANALYZER

K980505 · Hortmann AG · EWO · Apr 7, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K980505
• Device Name: HORTMANN AMDIS-OAE OAE ANALYZER
• Applicant: Hortmann AG
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Apr 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Use of the AmDiS otoacoustic Emissions Test Instrument is indicated in any case which requires objective assessment of the inner ear function, e.g., during hearing screening in infants, or for the documentation of ocupational hearing loss.

Device Story

AmDIS-OAE Otoacoustic Emissions Analyzer performs objective assessment of inner ear function. Device inputs acoustic stimuli into ear canal via probe; detects low-level acoustic emissions (otoacoustic emissions) generated by outer hair cells of cochlea. System processes detected signals to provide objective data on cochlear health. Used in clinical settings by healthcare professionals for infant hearing screening and occupational hearing loss documentation. Output assists clinicians in identifying hearing impairment or monitoring auditory function. Benefits include non-invasive, objective evaluation of inner ear status without requiring patient behavioral response.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Otoacoustic emissions analyzer; utilizes probe-based acoustic stimulation and detection. Class II device (21 CFR 874.1050).

Indications for Use

Indicated for objective assessment of inner ear function in patients requiring hearing screening, including infants, and for documentation of occupational hearing loss.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 1998

Bradford. Melancon c/o Danplex-Hortmann, Inc. P.O. Box 119 Dripping Spring, TX 78620 Re:

K980505 Hortmann AmDIS-OAE Otoacoustic Emissions Analyzer Dated: February 4, 1998 Received: February 9, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

Dear Mr. Melancon:

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 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 (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 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/cdrb/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

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

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): K980505

Device Name: Hortmann AmDIS-OAE Otoacoustic Emissions Analyzer

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Indications For Use:

Use of the AmDiS otoacoustic Emissions Test Instrument is indicated in any case which requires objective assessment of the inner ear function, e.g., during hearing screening in infants, or for the documentation of ocupational hearing loss.

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Concurrence of CDRH, Office of Device Evaluation (ODE)----

Thiriel C. Sygmm

(Division Sign-Off) Division of Reproductive. Abdominal, ENT, and Radioingreal Ca 510(k) Number

V Prescription Use _ (Per 21 CFR 801.109)