(60 days)
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.
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.
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 |
§ 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.