# K980505: Hortmann Amdis-Oae Oae Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Hortmann AG
- Decided: Apr 7, 1998 after 57 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
Use of the AmDIS otoacoustic Emissions Test Instrument is indicated in any case which requires objective assessment of the inner ear function, e.g., during hearing screening in infants, or for the documentation of ocupational hearing loss.

Source page: https://510kreport.com/device/K980505
Methodology: https://510kreport.com/methodology