# K043396: Integrity, Model V500

- Pathway: 510(k) (Traditional)
- Applicant: Vivosonic, Inc.
- Decided: Jan 24, 2005 after 45 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- 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
DPOAE and TEOAE Test Option The Integrity V500 with DPOAE and TEOAE test options 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. DPOAE and TEOAE tests do not measure hearing per se, but measure 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. ABR/ASSR Test Option The Integrity V500 with ABR/ASSR options is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

Source page: https://510kreport.com/device/K043396
Methodology: https://510kreport.com/methodology