# K103298: Acam 5 Audiometer System

- Pathway: 510(k) (Traditional)
- Applicant: Acousticon GmbH
- Decided: Apr 8, 2011 after 151 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 K071462 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071462: Unity 2 Hia & Probe ( for Use with Unity 2), Siemens Hearing Instruments, Inc. (2007) Summary page 1.
- (no number) Siemens Unity 2: named in the summary without a submission number

## Indications for use
ACAM® 5 is intended as an aid in diagnosing hearing loss and fitting of hearing aids. The device consists of an audiometer that can be used individually or with the other ACAM modules for performing Real Ear Measurements (REM), Hearing Instrument Test (HIT) and loudness scaling. ACAM 5® should be used by persons trained in audiology on patients of any age who are able to understand the basic principles of the test method when explained by the operator.

Source page: https://510kreport.com/device/K103298
Methodology: https://510kreport.com/methodology