# K033108: Vivo 200 DPS Vivoscan Version 2.0 Oae Audiometer

- Pathway: 510(k) (Special)
- Applicant: Vivosonic, Inc.
- Decided: Oct 27, 2003 after 27 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. The FDA summary names its predicate without a number.
- (no number) Vivo 200 DPS OAE Audiometer: named in the summary without a submission number

## Indications for use
The Vivo 200 DPS VivoScan Version 2.0 is indicated for use when it is necessary for a trained health care professional (for example an Audiologist) to measure or determine cochlear function by measuring, recording and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation. The Vivo 200 DPS VivoScan Version 2.0 does not measure hearing per se, but measures whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria. The Vivo 200 DPS VivoScan Version 2.0 is indicated for patients of all ages from newborn through adults, to and including geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The Vivo 200 DPS VivoScan Version 2.0 is a prescription device. The labeling instructions and user operations are designed for trained professionals.

Source page: https://510kreport.com/device/K033108
Methodology: https://510kreport.com/methodology