(87 days)
The CCA-220 Audiometer is an air-conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-220 through a Telephonics TDH-39 headset. The test subject then presses a hand switch to indicate to the CCA-200 that the tone has been heard. The CCA-220 proceeds with the hearing testing, and records the subject's responses. The resultant test data are available to print on an integral printer or to store in the CCA-220's hard drive.
The CCA-220 has an integral computer which provides all of the capabilities of the instrument. The instrument's display panel shows the setup and control screens that are used to perform. the test functions. The instrument is based on an integral PC compatible computer with a Pentitura processor, running the operating system of Microsoft Windows 95. Control of the CCA-220 is handled by selecting the desired test elements on the touch screen monitor. The instrument also incorporates an internal printer for printing test results. The CCA-220 has a range of options for both computer interfacing and automatic testing, such as error detection and multilingual voice instruction. These options are selected using the setup screen on the touch-screen monitor.
The provided text is a 510(k) premarket notification letter and the "Indications for Use" statement for the CCA-220 Audiometer. It describes the device's function and intended use but does not contain any information about acceptance criteria, study details, or performance metrics.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and the device's general capabilities, not on clinical performance studies or specific acceptance criteria.
§ 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.