AUDIOSCAN VERIFIT, MODEL VF-1

K012306 · Etymonic Design, Inc. · ETW · Sep 21, 2001 · Ear, Nose, Throat

Device Facts

• Record ID: K012306
• Device Name: AUDIOSCAN VERIFIT, MODEL VF-1
• Applicant: Etymonic Design, Inc.
• Product Code: ETW · Ear, Nose, Throat
• Decision Date: Sep 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3310
• Device Class: Class 2

Intended Use

The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic reference device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber or a hearing aid when worn by a patient.

Device Story

Audioscan Verifit VF-1 is a hearing aid analysis system; used by hearing aid manufacturers and dispensers. Device inputs include acoustic signals from hearing aids; processed via digital signal processing (DSP) to assess electroacoustic performance (frequency, intensity, distortion). System comprises a display/control unit and a physically separate test chamber. Operates by measuring output of hearing aids in a test chamber or via probe microphone in a patient's ear canal. Output provided to clinician via color display/printer; assists in fitting and calibration of hearing aids. Benefits include optimized hearing aid performance and patient sound quality. Safety ensured by F-Type Applied Part classification for probe assembly; no direct electrical patient connection.

Clinical Evidence

Bench testing only. Device performance verified against ANSI S3.46-1997 and ANSI S3.22-1996 standards. Safety verified against IEC 60601-1, EN60601-1, UL-2601, and UL 544. Software validation performed per FDA guidance.

Technological Characteristics

System uses digital signal processing (DSP) for analysis. Features color SVGA display, dual stimulus channels, and independent speakers. Probe microphone assembly uses silicone tubing. Connectivity includes Ethernet, USB, RS232, and parallel ports. Powered by electrical mains; meets IEC 60601-1 safety standards. Test chamber includes induction coils and battery simulators per ANSI S3.22-1996.

Indications for Use

Indicated for manufacturers and dispensers of hearing aids to calibrate and assess electroacoustic frequency and sound intensity characteristics of hearing aids, either coupled to an ear simulator in a test chamber or worn by a patient.

Regulatory Classification

Identification

A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.

Special Controls

*Classification.* Class II (special controls). The device 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

• Audioscan® Real Ear Measurement System RMS00 (K884046/A)

Submission Summary (Full Text)

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Edi E

sion incorporated

41 Byron Avenue, Dorchester, Ontario NOL 1G0 Tel: [phone] Fax: [phone]

SEP 2 1 2001

K012306

## SECTION E - 510(K) SUMMARY OF SAFETY & EFFECTIVENESS

## Audioscan® Verifit™ Model VF-1

| Classification Name: | Hearing-Aid Calibrator & Analysis System |
|-----------------------------|--------------------------------------------|
| Common/Usual Name: | Hearing Aid Analyzer |
| Proprietary Name: | Audioscan ^® Verifit™ Model VF-1 |
| Establishment Registration: | 8022229 |
| Medical Specialty: | Panel 77, Ear, Nose, & Throat |
| Product Code: | ETW |
| Regulation Number: | 21 CFR 874.3310 |
| Device Classification: | II |
| Contact Person: | William A Cole, President |

#### Indications for Use:

The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic reference device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber or a hearing aid when worn by a patient.

## Performance Standards Conformance:

- 1. The VF-1 meets or exceeds the equipment requirements of the following standards: American National Standards Institute, Methods of Measurement of Real-Far Performance Characteristics of Hearing Aids, (ANSI S3.46-1997), American National Standards Institute, New York, 1997, and, American National Standards Institute, Specification of Hearing Ald Characteristics, (ANSI S3.22-1996), American National Standards Institute, New York, 1996.
- 2. The VF-1 meets or exceeds the applicable requirements of the following standards for safety: IEC 60601-1, EN60601-1, UL-2601 and UL 544.

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Etymonic Design Incorporated Applied Microelectronics

- The VF-1 meets or exceeds the Food and Drug Administration radiation safety 3. performance standards prescribed in the Code of Federal Regulations, Title 21, Chapter I. Subchapter J.
#### Substantial Equivalence:

Determination of substantial equivalence of the Audioscan® Verifit™ VF-1 instrument to the currently marketed Audioscan® Real Ear Measurement System RMS00, 510(k) No. K884046/A, February 13, 1989, is based on the following safety and effectiveness information:

- The Audioscan® Verifit™ device is manufactured and delivered completely . assembled to the health care professional using materials and techniques widely used by other manufacturers of devices as with the predicate device.
- Patient safety is preserved in both the Audioscan® Verifit™ and predicate . devices. There is no direct electrical connection to the patient. The silicone probe microphone assembly that has contact with the patient's ear canal during the testing of the hearing aid, has no exposed metal parts and is classed as an F-Type Applied Part in UL2601-1. Thus, there is no possibility of electrical conductance.
- Regarding physical configurations, the system is integrated with the hearing test ● chamber physically part of the display/control unit in the predicate device, whereas the Audioscan® Verifit™ hearing aid test chamber is physically separated from the display/control unit.
- Software algorithms are essentially equivalent for both the Audioscan® Verifit™ t and predicate devices.
- To establish the safety and effectiveness of the software that controls the . instrument, the development, verification, validation, and testing procedures are in accordance with FDA guidances for devices containing software 12, Quality Assurance procedures are adhered to and test results demonstrate that both system specifications and function requirements are met.

¹ Guidance Principles of Software Validation, Draft Guidance Version 1.1, June 9, 1997, Center for Devices and Radiological Health, Food and Drug Administration

² ODE Guidance for the Content of Premarket Submission for Medical Devices Containing Software, May 29, 1998, Center for Devices and Radiological Health, Food and Drug Administration

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Etymonic Design Incorporated Applied Microelectronics

41 Byron Avenue, Dorchester, Ontario NoL. 1G0 Tel: [phone] Fax: [phone]

- The maximum sound level output of the Audioscan® Verifit™ speakers, if used . as intended, remains below +90 dB SPL throughout the frequency range of 200 to This demonstrates that the Audioscan® Verifit™ unit emits sounds 8000 Hz. well within OSHA permissible exposure limits of 8 hours at 90 dB, The maximum sound level output of the predicate device speakers is 85 dB SPL if used as intended.
- The signal processing and analysis differ between the Audioscan® Verifit™ and . the predicate device. Signals are processed and analyzed by digitally controlled analog amplifiers, attenuators and filters in the predicate device. In the Audioscan® Verifit™, with the exception of the microphone preamplifiers and output amplifiers, all signal processing and analysis is carried out digitally.

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vmon n Incorporated

41 Byron Avenue, Dorchester, Ontanio NOL 1G0

| CHARACTERISTIC | MODEL RM500 | VERIFIT™ MODEL<br>VF-1 |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GENERAL | | |
| Overall dimensions | 15.5" x 13.2" x 6.2" | Rear main unit 14.5" x 16" x 6.5"<br>Test chamber 14" x 14.4" x 4" |
| Weight | 15 lbs | 16 lbs |
| Display type | fluorescent backlit blue on<br>white | fluorescent backlit active color |
| Display size | 6.4" diagonal | 12.1" diagonal |
| Display pixels (resolution) | 320 x 200 (VGA) | 800 x 600 (SVGA) |
| Printer type | thermal line printer | SAME |
| Printer resolution | 200 dots per inch | SAME |
| Paper width | 3" (80 mm) | SAME |
| Connectors | 1 - external monitor (15HD)<br>1-RS232 (9D)<br>1 - external speaker (RCA)<br>1 - real-ear/coupler mic. (RJ11) | 1 - mouse (PS2-6 pin)<br>1 - QWERTY keyboard (PS2-6pin)<br>1 - external monitor (15HD)<br>1 - parallel printer (25D)<br>1 - RS232 serial (9D)<br>1 - ethernet (RJ45)<br>2 - USB<br>2 - external speakers (RCA)<br>2 - external speakers (1/4" mono))<br>2 - real-ear mics. (3.5 mm st)<br>1 - RECO transducer (3.5 mm st)<br>1 - monitor headset (3.5 mm st)<br>1 - test chamber ref. mic. (3.5 mm st)<br>1 - coupler microphone (3.5 mm st)<br>1 - battery substitute (3.5 mm st) |
| Headphone monitor amplifier | 1 watt into 16 ohms | SAME |
| Power amplifiers | 1 - 1.7 watts | 2 - 5 watts each |
| Stimulus channels | 1 | 2 |
| Measurement channels | 2 | SAME |
| HEARING AID TEST CHAMBER | | |
| Working space | 5.5" x 3.5" x 2" | 8" x 5" x 1.5" (approx.) |
| Speakers | 1 - 3.5" diameter | 2 - 2" x 3" Independent |
| Induction coils | 1 - Telephone Magnetic Field<br>Simulator (TMFS ANSI S3.22 -<br>1996)<br>1 - 20 cm diameter test loop | SAME |
| Battery simulator | per ANSI S3.22 - 1996 | SAME |
| Frequency range | 200 to 8000 Hz | SAME |
| Test stimuli | tone | tone, broad-band noise, recorded<br>speech |
| CHARACTERISTIC | MODEL RM500 | VERIFIT™ MODEL<br>VF-1 |
| Test stimulus levels | 40 to 90 dB SPL in 5 dB steps | SAME |
| Test stimulus levels (inductive) | 31.6 mA/m per ANSI S3.22 -1996 | SAME |
| Test stimulus distortion | <2% at 90 dB SPL<br><0.5% at 70 dB SPL | SAME |
| Test stimulus accuracy at reference<br>microphone for tones (200 - 2000 Hz) | ± 1.5 dB SPL | SAME |
| Test stimulus accuracy at reference<br>microphone for tones (2000 -8000 Hz) | ± 2.5 dB SPL | SAME |
| Equalization method | pressure method | SAME |
| Analysis frequencies per octave | 12 | SAME |
| Analysis filter bandwidth | 1/7 octave | 1/12 octave |
| Measurement accuracy at 1 kHz | ± 1 dB | SAME |
| Measurement accuracy re 1 kHz | ± 1 dB (200 - 5000 Hz)<br>± 2.5 dB (5000 - 8000 Hz) | SAME |
| Measurement range | 30 - 140 dB SPL | SAME |
| Harmonic distortion measurement | 2nd plus 3rd | 2nd and 3rd or 2nd plus 3rd |
| Harmonic distortion range | 200 to 2670 Hz | 200 to 4000 Hz |
| Harmonic distortion accuracy | ± 1% | SAME |
| Battery drain range | 0-20 mA | SAME |
| Battery drain accuracy | ± .01 mA | SAME |
| ANSI S3.22-1996 tests available | ➤ OSPL90<br>➤ Full-on Gain<br>➤ Reference Test Gain<br>➤ Frequency Response<br>➤ Frequency Range<br>➤ Maximum OSPL90<br>➤ Harmonic Distortion<br>➤ Attack & Release time<br>➤ Equivalent Input Noise<br>➤ Input/Output Curves<br>➤ Coupler SPL - Telephone<br>Simulator<br>➤ Simulated Telecoil<br>➤ Sensitivity<br>➤ Battery drain | SAME<br>With the added features:<br>➤ Coupler SPL - Vertical<br>➤ Magnetic Field<br>➤ Test Loop Sensitivity |
| Other tests available | ➤ coupler SPL vs frequency<br>➤ spectral analysis<br>➤ manual measurement of<br>➤ output, gain and distortion | SAME<br>With the added features:<br>➤ coupler gain vs frequency<br>➤ distortion vs frequency |
| REAL-EAR MEASUREMENT | | |
| Speakers | 1 - 3.5" diameter | 2 - 2" x 3" ducted ports |
| CHARACTERISTIC | MODEL RM500 | VERIFIT™ MODEL |
| | | VF-1 |
| Probe microphone tube | Silicone 1.0mm diameter x<br>75mm | SAME |
| Frequency range | 200 to 8000 Hz | SAME |
| Test stimuli | frequency-modulated tone, tone<br>burst, amplitude-modulated tone | frequency-modulated tone, tone<br>burst, broad-band noise, recorded<br>speech |
| Frequency modulation | triangular ±5% at 36 Hz | SAME |
| Test stimulus levels at reference<br>microphone for tones at 1 m | 40 to 85 dB SPL in 5 dB steps | 40 to 90 dB SPL in 5 dB steps |
| Test stimulus accuracy at reference<br>microphone for tones (200 - 2000 Hz) | ± 1.5 dB SPL | SAME |
| Test stimulus accuracy at reference<br>microphone for tones (2000 -8000 Hz) | ± 2.5 dB SPL | SAME |
| Equalization method | pressure method | SAME |
| Analysis frequencies per octave | 12 | SAME |
| Analysis filter bandwidth | 1/7 octave | 1/12 octave |
| Measurement accuracy at 1 kHz | ± 1 dB | SAME |
| Measurement accuracy re 1 kHz | ± 1 dB (200 - 5000 Hz)<br>± 2.5 dB (5000 - 8000 Hz) | SAME |
| Measurement range | 20-135 dB SPL (200 - 2500<br>Hz)<br>30 - 140 dB SPL (2500 - 8000<br>Hz) | SAME |
| ANSI S3,46-1997 tests available | > Real-Ear Unaided<br>Response<br>> Real-Ear Aided Response<br>> Real-Ear Occluded<br>Response<br>> Real-Ear Insertion Gain | SAME |
| Other tests available | > Real-ear harmonic<br>distortion<br>> Real-ear spectral analysis<br>> manual measurement of<br>output, gain and distortion | SAME |
| Prescriptive fitting methods available | > National Acoustics Labs<br>Revised<br>> Pogo II<br>> Berger<br>> Libby<br>> Desired Sensation Level | SAME |

# Specification Comparison Table

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41 Byron Avenue, Dorchester, Ontario NOL 1G0 Tel: [phone] Fax: [phone]

NOTES:

The couplers used in the RM500 hearing aid test chamber are also used in the Verifit™ VF-1. 1)

2) The probe tubes used with the RM500 real-ear microphone assembly are also used with the VF-1.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2001

William A. Cole, President Etymonic Design Incorporated 41 Byron Avenue Dorchester, Ontario N0L 1G0

Re: K012306

Trade Name: Audioscan Verifit™ Regulation Number: 21 CFR 874.3310 Regulation Name: Hearing Aid Calibrator and Analysis System Regulatory Class: Class II Product Code: ETW Dated: July 20, 2001 Received: July 23, 2001

Dear Mr. Cole

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - William A. Cole, President

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

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

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Etymonic Design Incorporated Applied Microelectronics

41 Byron Avenue, Dorchester, Ontario N0L 1G0 Fax: [phone] Tel: [phone]

# SECTION D - INDICATIONS FOR USE STATEMENT

er/ 3 - 4/24/96

Applicant: Etymonic Design Incorporated

510(k) Number (if known):

Device Name: Audioscan® Verifit™

Indications For Use

The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic referenc device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber or a hearing aid when worn by a patient.

Ama H. Kane Ph.D. 9/17/01
Division Sign-Off

Division Sign-Off) Division of Ophthalmic Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)