(71 days)
The portaREM-3000,PFS-6000 is a portable hearing aid dispensing system which allows the Hearing Health Care Professional to test hearing aids to IEC/ANSI standards. It also allows for Real Ear testing, and In Situ Audiometry via the use of the probe microphone, and offers a 2cc coupler conversion in which the 2cc coupler response desired can be determined from the audiogram. Standard puretone measurement is also available. With the PFS software, which will be standard with PFS-6000 and optional for the pR-3000, prescriptive formulas, matrix and hearing aid selection, order form printing, along with other optiions described in the user manual are available.
The portaREM-3000, PFS-6000 is a portable hearing aid dispensing system. It includes electronic circuitry, a 4.7" color LCD monitor with 640*480 resolution, a built-in Thermoprinter, a loudspeaker, a 3.5 inch disk drive, a test chamber for hearing aid measurement, a battery simulator, two RS-232 serial port interfaces, and a real ear probe mic. It is controlled by a fully functional PC style keyboard.
The provided document is a summary of the Rastronics portaREM-3000 and Starkey PFS-6000, which are hearing aid calibrator and analysis systems. It describes the device's intended use, features, technical characteristics, and controls. However, it does not contain any information about a study to prove acceptance criteria or any reported device performance data in the format requested.
The document primarily focuses on the device's specifications and capabilities, not on clinical performance or validation studies that would involve acceptance criteria, sample sizes, ground truth establishment, or expert evaluations. It states that "Technical specifications complies to IEC 601 and FCC part 15 class B," but this refers to electrical safety and electromagnetic compatibility standards, not performance metrics related to its intended function as a hearing aid calibrator and analysis system.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.
{0}------------------------------------------------
JAN | 0 1997
SAFETY AND EFFECTIVENESS SUMMARY portaREM-3000, PFS-6000
NAME OF DEVICE: Rastronics portaREM-3000, Starkey PFS-6000
TYPE OF DEVICE: Hearing aid calibrator and analysis system
INTENDED USE: The portaREM-3000,PFS-6000 is a portable hearing aid dispensing system which allows the Hearing Health Care Professional to test hearing aids to IEC/ANSI standards. It also allows for Real Ear testing, and In Situ Audiometry via the use of the probe microphone, and offers a 2cc coupler conversion in which the 2cc coupler response desired can be determined from the audiogram. Standard puretone measurement is also available. With the PFS software, which will be standard with PFS-6000 and optional for the
pR-3000, prescriptive formulas, matrix and hearing aid selection, order form printing, along with other optiions described in the user manual are available.
FEATURES:Easy to use menu-driven software, connections for color monitor and external printer, complete 2cc coupler test according to IEC/ANSI, intermodulation distortion measurement, composite signals, Ear Canal Resonance(REUR), Insertion gain measurements(REIR), In Situ response(REAR), In Situ audiometry, Real Ear 2cc coupler conversion(NAL), Insertion gain with Prescription Rules and Articulation Index, Fitting prescriptions:NAL, POGO II, 1/2 Gain, 1/3 Gain, 1/3 Gain, and Berger. There is a 3.5 inch disk drive, built in Thermoprinter for hard copy, test chamber for hearing aid measurement, 4.7" color LCD monitor, battery simulator, two RS-232 serial port interfaces, real ear probe mic.
ASSEMBLY: Electronic circuitry all complies to IEC 601 and FCC part 15 class B. Display is 4.7" LCD 640*480 resolution, color monitor, Thermoprinter. Loudspeaker min. 6W in 4 Ohms, freq. range 50 Hz-15,000 Hz. All electrical components are of a standard, off the shelf variety.
TECHNICAL
CHARACTERISTICS: Technical specifications complies to IEC 601 and FCC part 15 class B, 2 channels, LCD monitor, Thermoprinter, single 3.5 in floppy drive, measurement circuits freq. range: 42 - 15600 Hz, dynamic range: 130 dB, dynamic resolution: 0.25 dB, accuracy: ±0.2dB, loudspeaker output: min. 6W in 4 Ω, freq. range: 50 - 15000 Hz, electrical THD:< 0.01% MDD compliance will be achieved by Jan. 1997.
CONTROLS: The keyboard is a fully functional PC style keyboard.
POWER: 110 or 220 V ac; 50-60 Hz; at 220 V AC: 250 mA max., 110 V AC: 500 mA max.
10/28/196
§ 874.1050 Audiometer.
(a)
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.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.