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 Description

The Audioscan® Verifit™ is a hearing aid analysis system. The system is integrated with a hearing test chamber physically separated from the display/control unit. Signal processing and analysis is carried out digitally, with the exception of the microphone preamplifiers and output amplifiers. It includes a fluorescent backlit active color display, thermal line printer, and various connectors for peripherals and microphones. It has two stimulus channels and two measurement channels. The hearing aid test chamber has a working space of 8" x 5" x 1.5" (approx.), two 2" x 3" Independent speakers, and induction coils for Telephone Magnetic Field Simulator and a 20 cm diameter test loop. It also includes a battery simulator. The real-ear measurement component has two 2" x 3" ducted ports speakers and a Silicone 1.0mm diameter x 75mm probe microphone tube.

AI/ML Overview

Acceptance Criteria and Device Performance for Audioscan® Verifit™ Model VF-1

This document outlines the acceptance criteria and the reported performance of the Audioscan® Verifit™ Model VF-1, a hearing aid analysis system. The information is derived from the provided 510(k) summary (K012306).

1. Table of Acceptance Criteria and Reported Device Performance

The Audioscan® Verifit™ Model VF-1 demonstrates compliance with established industry standards and its predicate device (Audioscan® Real Ear Measurement System RMS00, K884046/A) across various performance characteristics. The acceptance criteria for this device are implicitly derived from these standards and the performance of the predicate device.

Key Performance Standards Conformance:

ANSI S3.46-1997, Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
ANSI S3.22-1996, Specification of Hearing Aid Characteristics
IEC 60601-1, EN60601-1, UL-2601, UL 544 (Safety Standards)
Food and Drug Administration radiation safety performance standards

The following table compares key characteristics between the Audioscan® Verifit™ Model VF-1 and its predicate device, Audioscan® Real Ear Measurement System RMS00. The "Acceptance Criteria" are understood to be meeting or exceeding the predicate device's performance, as well as conforming to the cited ANSI, IEC, and UL standards.

Characteristic	Predicate Device (MODEL RMS00)	Audioscan® Verifit™ Model VF-1 Performance (Reported)	Acceptance Criteria (Implicit)
GENERAL
Overall dimensions	15.5" x 13.2" x 6.2"	Rear main unit 14.5" x 16" x 6.5"; Test chamber 14" x 14.4" x 4"	Device must meet or demonstrate equivalent/improved functionality within reasonable physical configuration changes.
Weight	15 lbs	16 lbs	Minimal increase in weight is acceptable if functionality is improved.
Display type	fluorescent backlit blue on white	fluorescent backlit active color	Improved display technology is an enhancement, meeting or exceeding predicate.
Display size	6.4" diagonal	12.1" diagonal	Larger display is an enhancement, meeting or exceeding predicate.
Display pixels (resolution)	320 x 200 (VGA)	800 x 600 (SVGA)	Higher resolution is an enhancement, meeting or exceeding predicate.
Printer type	thermal line printer	SAME (thermal line printer)	Equivalent performance to predicate.
Printer resolution	200 dots per inch	SAME (200 dots per inch)	Equivalent performance to predicate.
Paper width	3" (80 mm)	SAME (3" (80 mm))	Equivalent performance to predicate.
Connectors	Fewer (e.g., 1 external monitor, 1 RS232)	More (e.g., mouse, QWERTY keyboard, ethernet, 2 USB, multiple audio)	Improved connectivity is an enhancement.
Headphone monitor amplifier	1 watt into 16 ohms	SAME (1 watt into 16 ohms)	Equivalent performance to predicate.
Power amplifiers	1 - 1.7 watts	2 - 5 watts each	Increased power amplifiers are an enhancement.
Stimulus channels	1	2	Increased stimulus channels are an enhancement.
Measurement channels	2	SAME (2)	Equivalent performance to predicate.
HEARING AID TEST CHAMBER
Working space	5.5" x 3.5" x 2"	8" x 5" x 1.5" (approx.)	Increased working space is an enhancement.
Speakers	1 - 3.5" diameter	2 - 2" x 3" Independent	Increased speakers are an enhancement.
Induction coils	1 (TMFS ANSI S3.22-1996, 1 - 20 cm diameter test loop)	SAME	Equivalent performance to predicate, conforming to ANSI S3.22-1996.
Battery simulator	per ANSI S3.22 - 1996	SAME	Conformance to ANSI S3.22-1996.
Frequency range	200 to 8000 Hz	SAME	Conformance to established range.
Test stimuli	tone	tone, broad-band noise, recorded speech	Added stimuli are an enhancement.
Test stimulus levels	40 to 90 dB SPL in 5 dB steps	SAME	Conformance to established levels.
Test stimulus levels (inductive)	31.6 mA/m per ANSI S3.22 -1996	SAME	Equivalent performance to predicate, conforming to ANSI S3.22-1996.
Test stimulus distortion	<2% at 90 dB SPL; <0.5% at 70 dB SPL	SAME	Maintaining low distortion, equivalent to predicate.
Test stimulus accuracy at reference microphone (tones 200 - 2000 Hz)	± 1.5 dB SPL	SAME	Conformance to established accuracy.
Test stimulus accuracy at reference microphone (tones 2000 - 8000 Hz)	± 2.5 dB SPL	SAME	Conformance to established accuracy.
Equalization method	pressure method	SAME	Equivalent performance to predicate.
Analysis frequencies per octave	12	SAME	Equivalent performance to predicate.
Analysis filter bandwidth	1/7 octave	1/12 octave	Improved (finer) filter bandwidth is an enhancement.
Measurement accuracy at 1 kHz	± 1 dB	SAME	Conformance to established accuracy.
Measurement accuracy re 1 kHz	± 1 dB (200-5000 Hz); ± 2.5 dB (5000-8000 Hz)	SAME	Conformance to established accuracy.
Measurement range	30 - 140 dB SPL	SAME	Conformance to established range.
Harmonic distortion measurement	2nd plus 3rd	2nd and 3rd or 2nd plus 3rd	More comprehensive measurement options are an enhancement.
Harmonic distortion range	200 to 2670 Hz	200 to 4000 Hz	Wider range for harmonic distortion measurement is an enhancement.
Harmonic distortion accuracy	± 1%	SAME	Conformance to established accuracy.
Battery drain range	0-20 mA	SAME	Conformance to established range.
Battery drain accuracy	± .01 mA	SAME	Conformance to established accuracy.
ANSI S3.22-1996 tests available	Standard set (e.g., OSPL90, Full-on Gain)	SAME, plus "Coupler SPL - Vertical" and "Magnetic Field - Test Loop Sensitivity"	Device must perform existing tests equivalently and offer added features.
Other tests available	Standard set (e.g., coupler SPL vs frequency)	SAME, plus "coupler gain vs frequency" and "distortion vs frequency"	Device must perform existing tests equivalently and offer added features.
REAL-EAR MEASUREMENT
Speakers	1 - 3.5" diameter	2 - 2" x 3" ducted ports	Improved speaker configuration is an enhancement.
Probe microphone tube	Silicone 1.0mm diameter x 75mm	SAME	Equivalent performance to predicate.
Frequency range	200 to 8000 Hz	SAME	Conformance to established range.
Test stimuli	frequency-modulated tone, tone burst, amplitude-modulated tone	frequency-modulated tone, tone burst, broad-band noise, recorded speech	Added stimuli are an enhancement.
Frequency modulation	triangular ±5% at 36 Hz	SAME	Equivalent performance to predicate.
Test stimulus levels at reference microphone for tones at 1m	40 to 85 dB SPL in 5 dB steps	40 to 90 dB SPL in 5 dB steps	Wider range for stimulus levels is an enhancement.
Test stimulus accuracy at reference microphone (tones 200 - 2000 Hz)	± 1.5 dB SPL	SAME	Conformance to established accuracy.
Test stimulus accuracy at reference microphone (tones 2000 - 8000 Hz)	± 2.5 dB SPL	SAME	Conformance to established accuracy.
Equalization method	pressure method	SAME	Equivalent performance to predicate.
Analysis frequencies per octave	12	SAME	Equivalent performance to predicate.
Analysis filter bandwidth	1/7 octave	1/12 octave	Improved (finer) filter bandwidth is an enhancement.
Measurement accuracy at 1 kHz	± 1 dB	SAME	Conformance to established accuracy.
Measurement accuracy re 1 kHz	± 1 dB (200-5000 Hz); ± 2.5 dB (5000-8000 Hz)	SAME	Conformance to established accuracy.
Measurement range	20-135 dB SPL (200-2500 Hz); 30-140 dB SPL (2500-8000 Hz)	SAME	Conformance to established range.
ANSI S3.46-1997 tests available	Standard set (e.g., Real-Ear Unaided Response)	SAME	Device must perform existing ANSI S3.46-1997 tests equivalently.
Other tests available	Standard set (e.g., Real-ear harmonic distortion)	SAME	Device must perform existing tests equivalently.
Prescriptive fitting methods available	Standard set (e.g., NAL-R, Pogo II)	SAME	Device must incorporate existing fitting methods equivalently.

2. Sample size used for the test set and the data provenance

The document provided (510(k) Summary K012306) does not explicitly detail a clinical test set with a specific sample size for human participants or a defined dataset of hearing aid measurements. Instead, the device's performance is demonstrated through:

Conformance to internationally recognized standards: ANSI S3.46-1997, ANSI S3.22-1996, IEC 60601-1, EN60601-1, UL-2601, UL 544, and FDA radiation safety standards. This implies comprehensive testing against these standards, which themselves define test methods and parameters.
Substantial Equivalence to a Predicate Device: The primary comparison is against the Audioscan® Real Ear Measurement System RMS00 (K884046/A). This involves demonstrating that the new device performs equivalently or better than the predicate device across all relevant technical specifications. The comparison table above illustrates this.
Software Validation: "development, verification, validation, and testing procedures are in accordance with FDA guidances for devices containing software." This refers to internal software testing, not a clinical test set with patient data.

Therefore, it is not possible to specify a sample size, country of origin, or whether the "data" was retrospective or prospective in the context of a clinical test set from this document. The validation relies on engineering testing, compliance with standards, and comparative analysis with a predicate device's established performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Given that the performance assessment relies on conformance to technical standards and comparison with a predicate device, as opposed to a clinical study with human interpretation, the concept of "experts establishing ground truth for a test set" with a specified number and qualifications (e.g., radiologists with 10 years of experience) is not applicable in the context of this device's submission.

The "ground truth" here is essentially the established specifications and accuracy requirements set forth by the ANSI, IEC, and UL standards, and the known performance baseline of the predicate device. The experts involved would be the engineers and quality assurance personnel who performed the testing and verified compliance with these standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

As there is no described clinical "test set" requiring interpretation or consensus among experts, no adjudication method (e.g., 2+1, 3+1) is mentioned or relevant in this 510(k) summary. The evaluation focuses on objective measurements against defined performance criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This device is a "Hearing-Aid Calibrator & Analysis System" designed for the objective measurement and calibration of hearing aids, not a diagnostic AI system assisting human readers. Therefore, an MRMC comparative effectiveness study evaluating human reader improvement with AI assistance is not applicable and was not performed or mentioned in this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The Audioscan® Verifit™ Model VF-1 is inherently a standalone device in terms of its ability to perform measurements and analysis based on its internal algorithms and hardware. Its primary function is to objectively measure electroacoustic characteristics. The "software algorithms are essentially equivalent for both the Audioscan® Verifit™ and predicate devices," and the device performs signal processing and analysis digitally.

Therefore, yes, its performance is de facto standalone in its measurement capabilities. However, it's crucial to understand that this is not an "AI algorithm only" device in the modern sense of a black-box AI standalone performance study. It is a measurement instrument that uses established algorithms to perform its functions. The device's "performance" described is its ability to accurately and consistently perform these measurements against known physical standards, rather than an "algorithm-only" performance compared to human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the Audioscan® Verifit™ Model VF-1 is based on:

Established engineering and electroacoustic standards: Primarily ANSI S3.46-1997 and ANSI S3.22-1996. These standards define how hearing aid characteristics should be measured and what acceptable performance ranges are.
Physical calibration references: The device measures physical properties (frequency, sound intensity, harmonic distortion, battery drain) against calibrated references.
Performance of the predicate device: The Audioscan® Real Ear Measurement System RMS00 (K884046/A) serves as a benchmark for equivalence.

Therefore, the ground truth is objective measurements against recognized standards and a known predicate device's performance, not expert consensus, pathology, or outcomes data from a clinical trial.

8. The sample size for the training set

The concept of a "training set" in the context of machine learning for an AI-powered device is not applicable here. The Audioscan® Verifit™ is a measurement and calibration instrument based on established scientific principles and algorithms, not a machine learning model that requires a training set of data. Its performance is validated against physical standards and a predicate device.

9. How the ground truth for the training set was established

Since the concept of a "training set" as understood in machine learning is not applicable to this device, the question of how its ground truth was established is also not applicable. The device's foundational principles are rooted in electroacoustic engineering and adherence to international measurement standards.

Summary

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Edi E

sion incorporated

41 Byron Avenue, Dorchester, Ontario NOL 1G0 Tel: (519) 268-3313 Fax: (519) 268-3256

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:

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.
1. 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: (519) 268-3313 Fax: (519) 268-3256

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™ MODELVF-1
GENERAL
Overall dimensions	15.5" x 13.2" x 6.2"	Rear main unit 14.5" x 16" x 6.5"Test chamber 14" x 14.4" x 4"
Weight	15 lbs	16 lbs
Display type	fluorescent backlit blue onwhite	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)1-RS232 (9D)1 - external speaker (RCA)1 - real-ear/coupler mic. (RJ11)	1 - mouse (PS2-6 pin)1 - QWERTY keyboard (PS2-6pin)1 - external monitor (15HD)1 - parallel printer (25D)1 - RS232 serial (9D)1 - ethernet (RJ45)2 - USB2 - external speakers (RCA)2 - external speakers (1/4" mono))2 - real-ear mics. (3.5 mm st)1 - RECO transducer (3.5 mm st)1 - monitor headset (3.5 mm st)1 - test chamber ref. mic. (3.5 mm st)1 - coupler microphone (3.5 mm st)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 FieldSimulator (TMFS ANSI S3.22 -1996)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, recordedspeech
CHARACTERISTIC	MODEL RM500	VERIFIT™ MODELVF-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<0.5% at 70 dB SPL	SAME
Test stimulus accuracy at referencemicrophone for tones (200 - 2000 Hz)	± 1.5 dB SPL	SAME
Test stimulus accuracy at referencemicrophone 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)± 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➤ Full-on Gain➤ Reference Test Gain➤ Frequency Response➤ Frequency Range➤ Maximum OSPL90➤ Harmonic Distortion➤ Attack & Release time➤ Equivalent Input Noise➤ Input/Output Curves➤ Coupler SPL - TelephoneSimulator➤ Simulated Telecoil➤ Sensitivity➤ Battery drain	SAMEWith the added features:➤ Coupler SPL - Vertical➤ Magnetic Field➤ Test Loop Sensitivity
Other tests available	➤ coupler SPL vs frequency➤ spectral analysis➤ manual measurement of➤ output, gain and distortion	SAMEWith the added features:➤ coupler gain vs frequency➤ 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 x75mm	SAME
Frequency range	200 to 8000 Hz	SAME
Test stimuli	frequency-modulated tone, toneburst, amplitude-modulated tone	frequency-modulated tone, toneburst, broad-band noise, recordedspeech
Frequency modulation	triangular ±5% at 36 Hz	SAME
Test stimulus levels at referencemicrophone 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 referencemicrophone for tones (200 - 2000 Hz)	± 1.5 dB SPL	SAME
Test stimulus accuracy at referencemicrophone 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)± 2.5 dB (5000 - 8000 Hz)	SAME
Measurement range	20-135 dB SPL (200 - 2500Hz)30 - 140 dB SPL (2500 - 8000Hz)	SAME
ANSI S3,46-1997 tests available	> Real-Ear UnaidedResponse> Real-Ear Aided Response> Real-Ear OccludedResponse> Real-Ear Insertion Gain	SAME
Other tests available	> Real-ear harmonicdistortion> Real-ear spectral analysis> manual measurement ofoutput, gain and distortion	SAME
Prescriptive fitting methods available	> National Acoustics LabsRevised> Pogo II> Berger> Libby> Desired Sensation Level	SAME

Specification Comparison Table

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41 Byron Avenue, Dorchester, Ontario NOL 1G0 Tel: (519) 288-3313 Fax: (519) 268-3256

NOTES:

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

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

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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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: (519) 268-3256 Tel: (519) 268-3313

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)

Regulation Number and Section

§ 874.3310 Hearing aid calibrator and analysis system.

(a)
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.(b)
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.