# K982878: Earscan 3

- Pathway: 510(k) (Traditional)
- Applicant: Micro Audiometrics Corp.
- Decided: Nov 3, 1998 after 81 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
Longest line of descent: 1 generation back to K812529 (1981). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K812529: Earscan, Micro Audiometrics Corp. (1981) Summary page 1.
- K940999: Prodigit 2000, Calmed Technology, Inc. (1994) Summary page 1.

## Most influential descendants
- K151025: iHearTest (2015), 0 descendants of its own

## Indications for use
Earscan 3 is a peripheral used with a computer that creates an air conduction, bone conduction and speech audiometer, as defined by the standards shown in the labeling of the About Screen and the Splash Screen of the Earscan 3 software.

Source page: https://510kreport.com/device/K982878
Methodology: https://510kreport.com/methodology