INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER

K981327 · Idem (Int'L Dist. of Electronics For Medicine) · EWO · May 11, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981327
• Device Name: INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
• Applicant: Idem (Int'L Dist. of Electronics For Medicine)
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: May 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The Interacoustics Model AD226 Diagnostic Audiometer is an electroacoustics instrument that produces and controls levels of test tones and signals intended for use in conducting diagnostic hearing tests and assisting in the diagnosis of possible otologic disorders.

Device Story

Interacoustics Model AD226 is an electroacoustic diagnostic audiometer; produces controlled test tones and signals for hearing assessment. Used by clinicians to assist in diagnosing otologic disorders. Device inputs include patient responses via hand-held push-button switch; outputs include auditory signals delivered via TDH 39 headset, Ear-Tone 3A insert phones, or B71 bone conductor. Features digital display; compatible with Windows-based software (IaBase95, PrintView, NOAH, Connex) for PC monitoring, database management, and hearing aid fitting. Provides clinical data to healthcare providers to inform diagnostic decisions regarding patient hearing health.

Clinical Evidence

Bench testing only. Compliance with IEC 645-1 Type 3, ANSI 3.6-1989, EN 60601-1:1990, and EN 60601-1-2:1993 standards.

Technological Characteristics

Electroacoustic instrument; digital display; frequency range 125-8000 Hz; masking via narrow band/white noise. Transducers: TDH 39 headset, Ear-Tone 3A insert phones, B71 bone conductor. Power: 100-115 or 230 V. Dimensions: 12x9x4 inches; weight 2.9 lbs. Connectivity: PC interface for database/fitting software. Standards: IEC 645-1 Type 3, ANSI 3.6-1989, EN 60601-1, EN 60601-1-2.

Indications for Use

Indicated for use in conducting diagnostic hearing tests and assisting in the diagnosis of possible otologic disorders in patients requiring audiometric evaluation.

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.

Predicate Devices

• Beltone Model 110 Audiometer

Submission Summary (Full Text)

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17981327

Page 1 of 2

MAY | | 1998

## 510(k) SUMMARY

PREPARED BY:

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

CONTACT PERSON:

TELEPHONE:

DATE ON WHICH THE SUMMARY WAS PREPARED:

March 25, 1998

707-746-8597

Donna Ward, President

NAME OF DEVICE

Interacoustics Diagnostic Audiometer Model AD226

COMMON NAME:

Audiometer

PREDICATE DEVICE:

Beltone Model 110 Audiometer

DESCRIPTION OF THE DEVICE

The interacoustics Model AD226 Diagnostic Audiometer is an The Interacoustics Model AD220 Diagnitudes controlled levels of test
electroacoustics instrument that produces and as a diagnectic hostring electroacousiic test instrument until processible stallegic disording tones and signals intended for acc in conductions of possible otologic disorders.

Comparison of the Interacoustics Model AD226 Acoustic audiometer and the Beltone Model 110 Audiometer follows:

Indication for use - Identical for both units.

Similarities and differences:

| Model AD226 Audiometer | Beltone Model 110 Audiometer |
|----------------------------------------------------------------------------|------------------------------|
| Digital Display. | Analog and Digital Display. |
| Available Frequencies (Hz): 125, 250,<br>500, 750, 1000, 1500, 2000, 3000, | Identical. |

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| 4000, 6000, 8000 | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Masking: Narrow Band Noise /White<br>Noise. | Narrow Band Noise, Speech Weighted<br>Noise, and White Noise. |
| Transducers: TDH 39 Headset; Ear-<br>Tone 3A Insert Phones and B71 Bone<br>Conductor. | TDH 50P Headset; B71 Bone<br>Conductor. |
| Patient response unit: Hand held push-<br>button switch. | Hand held push-button switch. |
| Compatible Windows Software:<br>IaBase95 database program; PrintView<br>for on-line PC Monitoring and printing;<br>NOAH hearing aid fitting software.<br>Connex hearing aid fitting software. | |
| Power: 100-115 or 230 V. | 105-125 VAC, 50-60 Hz; : Optional :<br>208-250 VAC ,50-60 Hz. |
| Size and Weight; Audiometer alone:<br>12x9x4 inches. Weight 2.9 lbs. | Audiometer alone: 16-1/8x9-3/4x 6-1/8<br>inches. Weight: 6lb 1oz. |
| External Power supply: 1.8 lbs. | |

SAFETY AND EFFECTIVENESS:

The Interacoustics Model AD226 Diagnostic Audiometer is in compliance with the following performance and safety standards:

Audiometers IEC 645-1 Type 3 ANSI 3.6-1989 and Safety: EN 60601-1:1990 EMC: EN60601-1-2:1993

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Public Health Service

Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol.

MAY | |-1998

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

Dear Ms. Ward:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K981327 Interacoustics Diagnostic Audiometer Model AD226 Dated: April 9, 1998 Received: April 13, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

We have reviewed your Section 510%) 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 [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/cdrb/dsmallsmamain.html".

Sincerely yours,

Kilian Yin

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

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l'agc

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Interacoustics Model AD226 Diagnostic Device Name:

Audiometer

Indications For Use:

The Interacoustics Model AD226 Diagnostic Audiometer is indicated for use in The Interacoustics Model AB220 Diagnostic and assisting in the diagnosis of possible otologic disorders.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vinit C. Seyson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981327

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)