# K981439: CCA-200

- Pathway: 510(k) (Traditional)
- Applicant: Benson Medical Instruments Co.
- Decided: Jun 15, 1998 after 55 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-200 Computer Controlled Audiometer is an air conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-200 through a TDH-39 headset to the test subject. The test subject then presses a hand switch to indicate to the CCA-200 that the tone has been heard. The CCA-200 proceeds with the hearing test using the Modified Hughson-Westlake method of hearing testing, and records the subject's responses. The resultant data are available to print on an external printer connected to the control computer or to store in the computer. The CCA-200 can perform its function only on command from a control computer. The computer monitor displays the setup and control screens that are used to perform the test functions. An IBM compatible computer with a 486DX2-50 or processor, running Windows 95 or Windows NT, is required. Control of the CCA-200 is handled through the RS232 serial port. The computer is not included with the CCA-200. The CCA-200 is designed for use in test environments where multiple automatic hearing tests are controlled from a single computer. The CCA-200 has a range of options for both computer interfacing and automatic testing, such as multilingual voice instructions. These options are selected using a setup screen on the computer.

Source page: https://510kreport.com/device/K981439
Methodology: https://510kreport.com/methodology