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Aurix Newborn Hearing Screening System
Vivosonic Inc · Model AURIX-1 · UDI-DI 00627908080011
10
510(k) clearances
119
Adverse events
4
Recalls
58
Facilities
Description
Main handheld unit for use with the Aurix system. The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following devices are accessories for use with the Aurix system: 11002 Sound Stimulator DI: 00627908080028 11003 Amplifier DI: 00627908080035 11010 Laptop Computer DI: 00627908080042 100116 Amplifier Lead Cable DI: 00627908080059 ER-3A-AUX Insert Earphones DI:00627908080066 100001 Electrodes DI: 00627908070067 100004 Ear Domes DI: 00627908080080 WA021 Tablet Computer DI: 00627908080097
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-06 | PATH | Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance |
| 2019-05-28 | GN Otometrics | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. |
| 2010-06-04 | Natus Medical Inc | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. |
| 2008-10-21 | Intelligent Hearing Systems Corp. | This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification ap |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.