# K982441: CCA-220

- Pathway: 510(k) (Traditional)
- Applicant: Benson Medical Instruments Co.
- Decided: Oct 9, 1998 after 87 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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 Pentium 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.

Source page: https://510kreport.com/device/K982441
Methodology: https://510kreport.com/methodology