# K193033: GSI Audera Pro

- Pathway: 510(k) (Traditional)
- Applicant: Grason Stadler
- Decided: Apr 24, 2020 after 176 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
Longest line of descent: 6 generations back to K930328 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163326: SmartEP, Intelligent Hearing Systems (2017) Summary page 4.
- K061443: Smart Usblite, Model M011120, Intelligent Hearing Systems (2006) Summary page 4.

## Indications for use
The Audera Pro is intended to be used for the stimulation, recording and measurement of auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses and otoacoustic emissions. The device is indicated for use in the evaluation, identification, documentation and diagnosis of auditory and vestibular disorders. The device is intended to be used on patients of any age. The Audera Pro is intended to be used by qualified medical personnel such as an audiologist, physician, hearing healthcare professional, or trained technician. The Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment. The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient’s ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient’s scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient’s ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient’s head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for otoacoustic emission (DPOAE, TEOAE) testing are the patient’s ear canal (with the contact object being an ear probe and eartip).

Source page: https://510kreport.com/device/K193033
Methodology: https://510kreport.com/methodology