INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER

K990585 · Idem (Int'L Dist. of Electronics For Medicine) · ETY · May 17, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K990585
• Device Name: INTERACOUSTICS AT22T AUTOMATIC 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 AT22t Automatic 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 AT22t is an electroacoustic diagnostic instrument used in clinical settings by healthcare professionals to evaluate hearing and otologic function. It functions by delivering controlled test tones and signals to the patient via TDH39 contralateral earphones and a probe tip. The device performs three primary diagnostic functions: tympanometry, acoustic reflex testing, and air conduction audiometry. It measures acoustic impedance and patient response via a handheld push-button switch. The device features digital display output and supports integration with PC-based software (IABase95, Printview, IA-NOAH-IMP) for monitoring, printing, and database management. By providing objective data on middle ear function and hearing thresholds, the device assists clinicians in diagnosing potential otologic disorders and determining appropriate patient care pathways.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and compliance with established performance standards: ANSI S3.6-1989, IEC 645-1-1992 (Audiometer), ANSI S3.39-1987, 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. Compliance range: 0.1 to 5 ml; Pressure range: +200 to -300 daPa; Probe tone: 226Hz. Connectivity: PC interface via IABase95, Printview, and IA-NOAH-IMP software. Power: 100-120V or 220-240V. Standards: ANSI S3.6-1989, IEC 645-1-1992, ANSI S3.39-1987, IEC 1027-1991, IEC 601-1-1988.

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 Automatic Impedance Audiometer

Submission Summary (Full Text)

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MAY 17 1999

Page 1 of 2

K990585

## 510(k) SUMMARY

PREPARED BY:

International Distributors of Electronics for Medicine, Inc. (IDEM) 4814 East Second St. Benicia, CA 94510

CONTACT PERSON:

TELEPHONE:

DATE ON WHICH THE SUMMARY WAS PREPARED:

NAME OF DEVICE:

COMMON NAME:

PREDICATE DEVICE:

800-947-6334

Donna Ward, President

February 19, 1999

Interacoustics Automatic Impedance Audiometer Model AT22t

Impedance Audiometer

Interacoustics Automatic Impedance Audiometer

DESCRIPTION OF DEVICE:

The Interacoustics AT22t Automatic 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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## Page 2 of 2 Comparison of the Interacoustics Model AT22t Automatic Impedance Audiometer and the Interacoustics Automatic Impedance Audiometer.

Indication for use - Identical for both units.

Similarities and differences:

| Interacoustics AT22t Automatic<br>Impedance Audiometer | Interacoustics Automatic Impedance<br>Audiometer |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Display Description: Digital | Digital |
| Available Frequencies:<br>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: +200 to -300daPa | Same |
| 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 | laBase Database program only |
| 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 16" x 6": 15.5 lbs | Same |

## SAFETY AND EFFECTIVENESS:

The Interacoustics AT22t Automatic 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 1999

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

Re: K990585

Device: Interacoustics AT22t Automatic 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,

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): ____________________________________________________________________________________________________________________________________________________ Interacoustics AT22t Automatic Impedance Audiometer Devicc Name:

Indications For Use:

バ

The Interacoustics AT22t Automatic 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.

| (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 Ophthalmic Devices | |
| 510(k) Number | K990585 |
| | 7/1/99 |

Prescription Use ﺳﮯ 是 (Per 21 CFR 801.109) OR

Over-The-Counter Use