INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER

K994254 · International Distributors of Electronics For Medi · ETY · Mar 14, 2000 · Ear, Nose, Throat

Device Facts

• Record ID: K994254
• Device Name: INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
• Applicant: International Distributors of Electronics For Medi
• Product Code: ETY · Ear, Nose, Throat
• Decision Date: Mar 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1090
• Device Class: Class 2

Intended Use

The Interacoustics AT235 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 AT235 is an electroacoustic diagnostic instrument used by clinicians to evaluate hearing and otologic function. It generates controlled test tones and signals delivered via transducers (TDH39 contralateral earphone and probe). The device performs tympanometry, acoustic reflex testing, and air conduction audiometry. Input data includes patient response via a handheld push-button switch. The device processes these inputs to provide diagnostic measurements, which are displayed digitally. It supports connectivity to Windows-based software (IABase95, Printview, IA-NOAH-IMP) for monitoring, printing, and database integration. The output assists clinicians in diagnosing otologic disorders. The device is intended for clinical use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and compliance with safety and performance standards, including ANSI S3.39-1987, IEC 1027-1991, ANSI 3.6-1989, IEC 645-1-1992, and IEC 601-1-1988.

Technological Characteristics

Electroacoustic impedance audiometer. Materials: TDH39 transducers, probe with probe tip. Energy: 100-120V or 220-240V AC. Standards: ANSI S3.39-1987 (Impedance), IEC 1027-1991 (Impedance), ANSI 3.6-1989 (Audiometer), IEC 645-1-1992 (Audiometer), IEC 601-1-1988 (Safety). Connectivity: PC interface via Windows software (IABase95, IA-NOAH-IMP). Form factor: 14" x 10" x 4", 6 lbs.

Indications for Use

Indicated for patients requiring diagnostic hearing evaluations and assessment of otologic disorders via 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 Impedance Audiometer (Interacoustics AT22t Automatic)

Submission Summary (Full Text)

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K994254/

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| MAR 1 4 2000 | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 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: | 800-947-6334 |
| DATE ON WHICH THE SUMMARY<br>WAS PREPARED: | December 14,1999 |
| NAME OF DEVICE: | Interacoustics AT235<br>Impedance Audiometer |
| COMMON NAME: | Impedence Audiometer |
| PREDICATE DEVICE: | Interacoustics Impedance Audiometer |

DESCRIPTION OF DEVICE:

The Interacoustics AT235 Impedence 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 AT235 Impedance Audiometer and The Interacoustics AT22t Automatic Impedance Audiometer.

Indication for use - Identical for both units.

Similarities and differences:

| Interacoustics AT235 | Interacoustics AT22t Automatic |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Impedance Audiometer | Impedance Audiometer |
| Display Description: Digital | Digital |
| Available Frequencies: | |
| 125 Hz, 250 Hz, 500 Hz, 1kHz, 2kHz,<br>3kHz, 4kHz, 6kHz, and 8kHz | 250 Hz, 500 Hz, 1kHz, 2kHz, 3kHz,<br>4kHz, 6kHz, and 8kHz |
| Probe Tone Frequency: 226Hz ± 3% | Same |
| Probe Tone Intensity: 85dB SPL ± 3dB | Same |
| Pressure Range: +300 to -600daPa | +200 to -300daPa |
| Compliance Range: 0,1 to 5 ml | Same |
| Transducers: TDH39 Single<br>Contralateral Earphone, Probe with<br>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 | Same |
| Tests: Tympanometry, Acoustic Reflex<br>and Air Conduction Audiometry | Same |
| Calibration: Impedance: ANSI S 3.39-<br>1987, IEC 1027-1991 | |
| Audiometer: ISO/R 389-1991 | Same |
| Power: 100-120 V or 220-240V | Same |
| Size and Weight: 14" x 10" x 4"; 6 lbs. | 14" x 16" x 6"; 15.5 lbs. |

## SAFETY AND EFFECTIVENESS:

The Interacoustics AT235 Impedance Audiometer is in compliance with the following performance and safety standards:

Audiometer: ANSI 3.6- 1989 IEC 645-1-1992 Type 4 Impedance: ANSI 3.39-1987 IEC 1027-1991 Type 2 Safety: IEC 601-1-1988

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized graphic of a bird-like figure, possibly representing an eagle, with three curved lines forming its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 1 4 2000

Ms. Donna Ward President International Distributors of Electronics For Medicine, Inc. (IDEM) 4814 East Second Street Benicia, CA 94510

Re: K994254 Trade Name: Interacoustics AT235 Impedance Audiometer Regulatory Class: II CFR: 874.1090 Product Code: 77ETY Dated: December 15, 1999 Received: December 17, 1999

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,

A Ralph 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): | K994254 |
|---------------------------|---------|
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Interacoustics Model AT235 Impedance Audiometer Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Usc:

The Interacoustics AT235 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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Over-The-Counter Use_ OR Prescription Use (Pcr 21 CFR 801.109) Sign-Off)

is on of Ophthalmic

510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Formal 1-2-96)