INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER

K990652 · Idem (Int'L Dist. of Electronics For Medicine) · ETY · May 17, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K990652
• Device Name: INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
• Applicant: Idem (Int'L Dist. of Electronics For Medicine)
• Product Code: ETY · Ear, Nose, Throat
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1090
• Device Class: Class 2

Intended Use

The Interacoustics AZ26 Clinical Impedance Audiometer is an electroacoustic test instrument 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. It features tympanometry, acoustic reflex and air conduction audiometry.

Device Story

The Interacoustics Model AZ26 is an electroacoustic clinical impedance audiometer used by clinicians to perform diagnostic hearing evaluations. The device generates controlled test tones and signals, including tympanometry, acoustic reflex, and air conduction audiometry. It utilizes a probe with a probe tip and a TDH39 single contralateral earphone to deliver stimuli and measure patient response via a handheld push-button switch. The system supports manual or automatic tympanometry, Eustachian tube tests (Williams and Toynbee), and Gelle tests. Data can be monitored and printed via PC-based software (IABase95, Printview, IA-NOAH-IMP). The device assists clinicians in diagnosing otologic disorders by providing objective measurements of middle ear function and hearing sensitivity. It features a digital display, pressure release functionality, and optional external keyboard support.

Clinical Evidence

No clinical data. The device relies on bench testing and compliance with established performance standards: ANSI S 3.6-1996, IEC 645-1-1992 (Audiometer), ANSI S 3.39-1987, IEC 1027-1991 (Impedance), and IEC 601-1-1988 (Safety).

Technological Characteristics

Electroacoustic impedance audiometer. Features digital display, TDH39 transducers, and handheld patient response switch. Calibration: ANSI S 3.39-1987, IEC 1027-1991, ISO/R 389-1991. Pressure range: -600 to +300 daPa. Probe tone: 226Hz ± 1%. Harmonic distortion < 5%. Connectivity: PC interface via IABase95, Printview, and IA-NOAH-IMP. Power: 100-120V or 220-240V. Dimensions: 19" x 16" x 6".

Indications for Use

Indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders in patients requiring tympanometry, acoustic reflex, and air conduction audiometry.

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

• Interacoustics Clinical Impedance Audiometer Model AZ26 (Older Model)

Submission Summary (Full Text)

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MAY 17 1999

K990652
510(k) SUMMARY

## PREPARED BY:

INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDICINE, INC. (IDEM) 4814 East Second Street Benicia, CA 94510

## CONTACT PERSON:

Donna Ward, President

TELEPHONE:

707-746-6334

DATE ON WHICH THE SUMMARY WAS PREPARED:

February 23, 1999

NAME IF DEVICE:

Interacoustics Model AZ26 Clinical Impedance Audiometer

COMMON NAME:

Clinical Impedance Audiometer

PREDICATE DEVICE:

Interacoustics Model Clinical Impedance Audiometer AZ26

DESCRIPTION OF DEVICE:

Our device, the Model AZ26 Clinical Impedance Audiometer is an electroacoustic test instrument 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. It features tympanometry, acoustic reflex and air conduction audiometry.

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## Comparison of the Interacoustics Model AZ26 Clinical Impedance Audiometer
Status County County City Learner Audiometer Model AZ26 Comparison of the interacousucs Model A226 Chineaning
and the Interacoustics Clinical Impedance Audiometer Model AZ26

Indication for use - Identical for both units.

Similarities and differences:

| Interacoustics AZ26 Clinical<br>Impedance Audiometer | Interacoustics Clinical Impedance<br>Audiometer Model AZ26 (OLDER<br>MODEL) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Display Description: Digital | Digital |
| Available Frequencies:<br>250 Hz, 500 Hz, 1kHz, 2kHz, 3kHz,<br>4kHz, 6kHz, and 8kHz | Same |
| Probe Tone Frequency:<br>226Hz ± 1% | Same |
| Probe Tone Intensity: 85dB SPL ±<br>1.5dB | Same |
| Harmonic Distortion:<br>Less than 5% | Same |
| Pressure Range:<br>-600 to +300 daPa | Same |
| Transducers:<br>TDH39 Single Contralateral Earphone,<br>Probe with Probe Tip | Same |
| Patient response unit: Handheld Push<br>Button Switch | Same |
| Compatible Windows Software:<br>IABase95 Database program, Printview<br>for On-line PC Monitoring and Printing,<br>IA-NOAH-IMP Module for Interfacing<br>to NOAH | IABase Database program only |
| Tests:<br>Tympanometry (Manual or Automatic),<br>Acoustic Reflex, Eustachian Tube Test<br>(Williams and Toynbee), Air Conduction<br>Audiometry, and Gelle Test | All except the Gelle Test and Toynbee<br>Eustachian Tube Test |
| Calibration: Impedance: ANSI S 3.39-<br>1987, IEC 1027-1991<br>Audiometer: ISO/R 389-1991 | Same |
| Pressure Release:<br>Pressure Release Function | None |
| Size and Weight: 19" x 16" x 6"; 21 lbs. | Same |
| Power: 100-120 V or 220-240V | Same |
| Opt. External Keyboard: yes | no |

INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDICINE, INC.
CONSULTIONAL DISTRIBUTORS OF EFFECT PENICIA CA 94510 USA TIONAL DISTRIBUTORS OF ELECTION, CA 94510 USA

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## SAFETY AND EFFECTIVENESS:

The Interacoustics Model AZ26 Clinical Impedance Audiometer is in compliance with the following performance and safety standards:

> Audiometer: ANSI S 3.6-1996 IEC 645-1-1992, Type 4 Impedance: ANSI S 3.39-1987 IEC 1027-1991, Type 1 Safety: IEC 601-1-1988

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or energy.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 1999

Ms. Donna Ward President IDEM 4814 East Second Street Benicia, CA 94510

Re: K990652

Device: Interacoustics Model AZ26 Clinical Impedance Audiometer Dated: February 23, 1999 Received: March 1, 1999 Classification Regulation: 77 ETY Auditory Impedance Tester, 21 CFR 874.1090 77 EWO Audiometer, 21 CFR 874.1050

Regulatory Class: II

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 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 .

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Page 2 - Ms. Donna Ward

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/cdrh/dsmamain.html".

Sincerely yours,

ARalph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K990652 Interacoustics AZ26 Clinical Impedance Audiometer Device Name:

Indications For Use:

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(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | 5/17/99 |
|--------------------------------|---------|
| Division of Ophthalmic Devices | |
| 510(k) Number | K990652 |

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use