The Otodynamics ILO288 ECHOPORTplus OAE System is designed to perform an auditory screening function by objectively testing for normal function of the cochlea. The system is designed to operate standalone, or optionally interface to an IBM compatible PC, using the parallel port.
Device Story
The ILO288 ECHOPORTplus OAE System performs objective auditory screening to assess cochlear function. The device captures otoacoustic emissions (OAE) via an ear probe; processes signals to evaluate cochlear response; and provides screening results to the clinician. It operates as a standalone unit or interfaces with an IBM-compatible PC via a parallel port. Used by clinicians in clinical settings to identify potential hearing impairment; results assist in determining the need for further diagnostic audiological evaluation. The system provides an objective measure of cochlear health, facilitating early detection of hearing loss.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
The system utilizes an ear probe for OAE signal acquisition. It is designed for standalone operation or PC connectivity via a parallel port. The device performs objective auditory screening of cochlear function.
Indications for Use
Indicated for auditory screening to objectively test for normal cochlear function in patients requiring hearing assessment.
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)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Otodynamics, LTD C/O Smith Associates E.J. Smith Consultant P.O. Box 4341 Crofton, MD 21114
K983350 Re:
IL0288 ECHOPORT plus OAE System Dated: September 23, 1998 Received: September 23, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Smith:
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 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 (QS) 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{1}------------------------------------------------
## 510(k) Number (if known:
Device Name: ILO288 ECHOPORTplus OAE System
Classification Panel:
Indications for Use:
The Otodynamics ILO288 ECHOPORTplus OAE System is designed to perform an auditory screening function by objectively testing for normal function of the cochlea. The system is designed to operate standalone, or optionally interface to an IBM compatible PC, using the parallel port.
## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
## Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________ 1 or
Over the Counter Use_
Daniel G. Segura
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number
