INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER

K982249 · Idem (Int'L Dist. of Electronics For Medicine) · EWO · Aug 7, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K982249
• Device Name: INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
• Applicant: Idem (Int'L Dist. of Electronics For Medicine)
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Aug 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The Interacoustics Model AD229 Diagnostic Audiometer is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. Because of its master hearing aid capability this device is also indicated for simulating a hearing aid during audiometric testing thus it may help in the selection and adjustment of a patient's hearing aid.

Device Story

Interacoustics Model AD229 is an electroacoustic diagnostic audiometer; generates controlled test tones and signals for hearing evaluation. Inputs include user-selected frequencies (125 Hz to 8000 Hz) and masking noise (narrow band, speech-weighted, white noise). Outputs delivered via TDH39 headset, EAR-Tone 3A insert phones, or B71 bone conductor. Device features master hearing aid capability for simulation and adjustment. Used in clinical settings by audiologists or trained technicians. Includes digital display and patient response push-button. Compatible with PC software (laBase95, PrintView, NOAH, Connex) for monitoring and database management. Benefits include precise diagnostic assessment of hearing thresholds and improved accuracy in hearing aid fitting.

Clinical Evidence

Bench testing only. The device was verified for compliance with IEC 645-1-1991 (Type 2), ANSI 3.6-1996 (Type 2), EN 60601-1:1990 (Safety), and EN 60601-1-2:1993 (EMC). No clinical data provided.

Technological Characteristics

Electroacoustic audiometer; Type 2 per IEC 645-1 and ANSI 3.6. Transducers: TDH39 headset, EAR-Tone 3A insert phones, B71 bone conductor. Power: 100-115 or 230 V with isolation transformer. Digital frequency switching (125-8000 Hz). Connectivity: PC interface for database/monitoring software. Form factor: 14x10x4 inches, 4 lbs.

Indications for Use

Indicated for patients requiring diagnostic hearing evaluations to assist in the diagnosis of otologic disorders and for patients requiring hearing aid simulation for the selection and adjustment of hearing aids.

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

• Qualitone Acoustic Appraiser CD-2 Audiometer/Master Hearing Aid

Submission Summary (Full Text)

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K982249

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## 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: | 707-746-8597 |
| DATE ON WHICH THE SUMMARY<br>WAS PREPARED: | June 24, 1998 |
| NAME OF DEVICE: | Interacoustics Diagnostic Audiometer<br>Model AD229 |
| COMMON NAME | Audiometer |
| PREDICATE DEVICE: | Qualitone Acoustic Appraiser CD-2<br>Audiometer/Master Hearing Aid |
| | |

DESCRIPTION OF THE DEVICE:

The Interacoustics Model AD229 Diagnostic Audiometer is an electroacoustic device that produces controlled levels of test tones and signals. The unit employs digital readouts and includes an external power supply that contains an isolation transformer. The tones and sound signals are directed to the patient by means of the following transducers: TDH39 Audiometric Headset (standard); EAR-Tone 3A Insert Phones (optional); and B71 Bone Conductor (standard). This device also has master hearing aid capability and utilizes either the TDH39 Headset or the Ear-Tone 3A Insert Phones for the acoustical outputs.

Comparison of the Interacoustics Model AD229 Diagnostic Audiometer and the Qualitone Acoustic Appraiser CD-2 Audiometer/ Master hearing aid follows:

Indication for use - Identical for both units.

Similarities and differences:

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| Model AD229 Audiometer | Qualitone Acoustic Appraiser CD-2 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Digital Display. | Analog and Digital Display. |
| Electronic Frequency Switching from<br>125 Hz to 8000 Hz with Digital<br>Readout. | Identical. |
| Masking: Narrow Band Noise, Speech<br>Weighted Noise, and White Noise. | Narrow Band Noise, Speech Weighted<br>Noise, and White Noise Masking. |
| Transducers: TDH 39 Headset; Ear-<br>Tone 3A Insert Phones and B71 Bone<br>Conductor. | TDH 39 Headset; and Bone Oscillator<br>Assembly. |
| Master Hearing Aid Capability -Yes | Yes |
| Speech and Tone Stimulation<br>Capability - Yes | Yes |
| Patient response unit: Hand held push-<br>button switch. | Hand held push-button switch. |
| Compatible Windows Software:<br>laBase95 database program; PrintView<br>for on-line PC Monitoring and printing;<br>NOAH hearing aid fitting software.<br>Connex hearing aid fitting software. | |
| Has output capability for optional<br>external speakers. | Two external SK-3 speakers included. |
| Compatible with external CD or Tape<br>Player. | Has built in CD Player. |
| Single Microphone. | Dual microphone. |
| Power: 100-115 or 230 V. | 110 or 220VAC only, 50-60 Hz |
| Size and Weight; Audiometer alone: | Portable Case Dimensions: 18- |
| 14x10x4 inches. Weight 4 lbs. | 1/2x14x9 inches. Weight: 27 lbs. |
| External Power supply: 1.8 lbs. | |

## SAFETY AND EFFECTIVENESS:

The Interacoustics Model AD229 Diagnostic Audiometer is in compliance with the following performance and safety standards:

Audiometers IEC 645-1-1991 Type 2 ANSI 3.6- 1996 Type 2 and Safety: EN 60601-1:1990 Electromagnetic Compatibility (EMC): EN 60601-1-2:1993

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG

For Medicine, Inc.

Benicia, CA 94510

4814 East Second Street

International Distributors of Electronics

Donna Ward

President

Re:

K982249 Interacoustics Model AD229 Diagnostic Audiometer Dated: June 24, 1998 Received: June 26, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO 21 CFR 874.3330/Procode: 77 KHL

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 (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 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 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/cdrh/dsmaldsmamain.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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510(k) Number (if known):

Interacoustics Model AD229 Diagnostic Audiometer Device Name:

Indications For Use:

The Interacoustics Model AD229 Diagnostic Audiometer is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Because of its master hearing aid capability this device is also indicated for simulating a hearing aid during audiometric testing thus it may help in the selection and adjustment of a patient's hearing aid.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.C. Phillips
Division of Oil

on of Reproductive, Abdominal, ENT, 510(k) Numbe

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)