# K983351: ILO292 DP Echoport Plus Oae System

- Pathway: 510(k) (Traditional)
- Applicant: Otodynamics, Ltd.
- Decided: Dec 11, 1998 after 79 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 Otodynamics IL0O292 DP ECHOPORTplus system performs an auditory screening function by objectively testing for normal function of the cochlea. It is a new concept in OAE screening and analysis since it operates in standalone mode, without a PC. It is based on the DP ECHOPORT Instrument but with added built-in processor and graphic display. Otodynamics IL0O292 DP ECHOPORTplus system provides DPOAE facilities in addition to all the screening and TEOAE functions of the ECHOPORTplus. Both TEOAE’s and DPOAE’s are useful as screening tests for cochlear function in infants, children and adults. They are particularly useful when the patient is unable to respond DPOAE’s are useful with older patients, as the method can tolerate sub-clinical depression of cochlear activity. DPOAE’s are also of use to test the higher frequency region of the cochlea.

Source page: https://510kreport.com/device/K983351
Methodology: https://510kreport.com/methodology