INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER

K983832 · Idem (Int'L Dist. of Electronics For Medicine) · ETY · Jan 25, 1999 · Ear, Nose, Throat

Device Facts

Record IDK983832
Device NameINTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
ApplicantIdem (Int'L Dist. of Electronics For Medicine)
Product CodeETY · Ear, Nose, Throat
Decision DateJan 25, 1999
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 874.1090
Device ClassClass 2

Intended Use

The Interacoustics MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of now sible otologic disorders.

Device Story

Handheld impedance audiometer for diagnostic and screening middle ear analysis; used in clinical settings by healthcare professionals. Device inputs include acoustic signals via probe tone (226 Hz) and pressure sweeps (+300 to -600 daPa). Performs tympanometry, ipsilateral acoustic reflex testing (fixed level or automatic intensity search), and screening audiometry. Produces digital measurements of compliance and reflex thresholds; provides hardcopy printouts for objective documentation of otitis media and middle ear disorders. Supports PC connectivity via Windows-based software (laBase 95, Printview, NOAH) for monitoring and data management. Benefits include quick, reliable assessment of middle ear function to aid clinical diagnosis.

Clinical Evidence

Bench testing only. Device performance verified against IEC 1027-1995, ANSI 3.60-1989, ANSI 3.60-1985, and IEC 601-1-1988 safety standards. No clinical trial data provided.

Technological Characteristics

Handheld impedance audiometer; digital display; NiMH or AA NiCa battery power. Probe tone: 226 Hz (+/-3%). Pressure range: +300 to -600 daPa/sec. Compliance range: 0.0 to 2.5 cc (displayed). Connectivity: PC interface via Windows software (laBase 95, Printview, NOAH). Standards: IEC 1027-1995, ANSI 3.60-1989/1985, IEC 601-1-1988.

Indications for Use

Indicated for patients requiring diagnostic or screening middle ear analysis to assist in the diagnosis of otologic disorders.

Regulatory Classification

Identification

An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.

Special Controls

*Classification.* Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K983832 Page 1 of 2 JAN 25 1999 ## 510(k) SUMMARY | PREPARED BY: | INTERNATIONAL DISTRIBUTORS OF<br>ELECTRONICS FOR MEDICINE, INC.<br>(IDEM)<br>4814 East Second Street<br>Benicia, CA 94510 | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | CONTACT PERSON: | Donna Ward, President | | TELEPHONE: | 707-746-6334 | | DATE ON WHICH THE SUMMARY<br>WAS PREPARED: | October 1, 1998 | | NAME IF DEVICE: | Interacoustics Model MT10 Handheld<br>Impedance Audiometer | | COMMON NAME: | Impedance Audiometer | | PREDICATE DEVICE: | Grason Stadler GSI- 37 Auto Tymp | DESCRIPTION OF DEVICE: Our device, the Model MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of possible otologic disorders. Comparison of the Interacoustics Model MT10 Handheld Impedance Audiometer and the Grason Stadler GSI-37 Auto Tymp. Indication for use - Identical for both units. Similarities and differences: | Model MT10 Handheld Impedance<br>Audiometer | Equivalent - Grason Stadler GSI-37<br>Auto Tymp | |---------------------------------------------|-------------------------------------------------| | Display Description: Digital | Digital | | Lightweight, handheld | Lightweight, handheld | {1}------------------------------------------------ | Hardcopy printout provides objective<br>documentation of otitis media and<br>other middle ear disorders. | Hardcopy printout provides objective<br>documentation of otitis media and<br>other middle ear disorders. | |----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Intensity: 10dBHL to 50dBHL | Not applicable | | Pressure range: +300 -600daPa/sec. | +200 -400 daPa/sec. | | Compliance range: .0 to 2.5 cc<br>displayed; .0 to 5.0 cc numeric | .0 to 1.5cm³ displayed | | Tests: tympanometry, acoustic reflex<br>and screening audiometry | Tympanometry | | Compatible Windows Software:<br>laBase 95 database program;<br>Printview for on-line PC monitoring and<br>printing; NOAH hearing aid fitting<br>software | None | | Standards: meets or exceeds<br>standards specified in IEC 1027-1995,<br>ANSI 3.60 -1989, ANSI 3.60-1985,<br>Safety IEC 601-1-1988 | Meets ANSI S3.39 - 1987 for Type 4<br>Instrument and IEC 601-1-1988 | | Available frequencies: .5kHz, 1kHz,<br>2kHz, 3kHz & 4kHz | Not applicable | | Probe tone: frequency: 226 Hz, +/-3% | 226 Hz, +/-3% | | Amplitude: 85dB SPL +/-3dB | 85.5 dB SPL, +/-2.0 dB | | Power: NiMH batteries or Standard AA<br>NiCa batteries | NiCad batteries | | Direction of Pressure Sweep: positive<br>to negative | Positive to negative | | Size and Weight: Probe: 4" x 10" x 5";<br>1 lb.; printer/charger: 12" x 9" x 4"; 4<br>lbs. 11.6 oz. | Probe: 2.4" x 8.3" x 4.3"; 10.5 oz;<br>printer/charger 9" x 7.6" x 4"; 3 lbs. | | External Power Supply: (optional) 1.8<br>Ibs (recharger power supply EPS11<br>power transformer-11 volts) | External Power Supply: (optional) 1.5<br>Ibs. (recharger power supply -9 volts) | ## SAFETY AND EFFECTIVENESS: The Interacoustics Model MT10 Handheld Impedance Audiometer is in compliance with the following performance and safety standards: > Standards in IEC 1027-1995, ANSI 3.60-1989, ANSI 3.60-1985, Safety IEC 601-1-1988. Approved for Medical CE-marking by Danish Notified Body D.G.M. Identification No. 0543, Quality System Certificate DGM 016 (CE 0543) {2}------------------------------------------------ Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 25 1999 Donna Ward President International Distributors of Electronics for Medicine, Inc. 4814 East Second Street Benicia, CA 94510 Re: K983832 Interacoustics Model MT10 Handheld Impedance Audiometer Dated: October 28, 1998 Received: October 30, 1998 Regulatory class: II: 21 CFR 874.1090/Procode: 77 ETY Dear Ms. Ward: 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 legally marketed predicate 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 (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 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 (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/cdrh/dsma/dsmamain.html". Sincerely yours, Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): 49838383 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Usc: The Interacoustics MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of now sible otologic disorders. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |---------------|-----------------------------------------------------------------------|--| | | (Division Sign-Off) | | | | Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | | | 510(k) Number | K983832 | | | Prescription Use | OR | Over-The-Counter Use | |----------------------|----|----------------------| | (Per 21 CFR 801.109) | | (Optional Format) | (Optional Formal 1-2-96)
Innolitics
510(k) Summary
Decision Summary
Classification Order
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