# K060883: Pilot Test or Detective Audiometers

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Jun 23, 2006 after 84 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 Pilot Test and Detective audiometers are both manual single channel pure tone air conduction audiometers used to test the hearing thresholds of children. The Pilot Test audiometer has the additional capability of using speech testing using "select picture" aUdiometry with Spondee word lists. The Detective audiometer has the additional capability to perform automatic pure-tone audiometry.

Source page: https://510kreport.com/device/K060883
Methodology: https://510kreport.com/methodology