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Sentiero AuDX

PATH medical GmbH · Model 8-04-16510 · UDI-DI 04260223143441

GWJ EWO Prescription

510(k) clearances

119

Adverse events

Recalls

Facilities

Description

Sentiero AuDX Set Content: 1. Sentiero Screening device AN100098-AU 2. Carrying case AN100928 3. Inlay AN100677 4. Probe EP-DP Path long AN100028-US 5. Accessory box Combo AB-03 AN100261-BL 6. DPOAE Quick Software AN100110-Quick 7. FMDPOAE Software AN100536 8. Software label printer AN100414 9. USB data cable AN100089 10. USB stick Bio-Logic AN100724-BL 11. Power supply Sentiero AN101013+AN100993-USA 12. Manual Bio-Logic AN100904-EN-BL

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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Data 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.