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Details checkedStatus confirmedCheckedregulatory

GSI Audera Pro

Also known as: Audera Pro, GSI Audera Pro, Audera Pro EP/OAE

Grason-Stadler

Primary source
Company
Grason-Stadler
Program Type
Diagnostic
Modality
Diagnostic
Stage
Marketed
Status
Marketed
Target Gene
—
Route / Mode
Clinic-based diagnostic hardware and software
Confidence
93%
Status Confidence
Status confirmed
Evidence Strength
Needs more support
Last Reviewed
2026-05-31
Geography
United States, Europe, Global
Population
pediatric, adult, congenital
Trial IDs
0
Mechanism

An evoked-potential and OAE system used for stimulation, recording, and measurement of ABR, ASSR, VEMP, and cochlear-function-related diagnostics.

Indications
Hearing LossAuditory Neuropathy
Notes

Important electrophysiology record in specialty audiology and pediatric diagnostic workups; current ownership ultimately sits under Natus.

Evidence & Sources
2 structured sources
company
Supports: canonicalName, company, mechanism, status, route
Open
regulatory
Supports: aliases, indications, stage, populationTags, geography
IDs: K193033
Open
Key Events
2020-04-24
FDA 510(k) documentation published for GSI Audera Pro
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