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Sentiero Basic AuDX Set

PATH medical GmbH · Model 100250-BL1 · UDI-DI 04260223143335

GWJ EWO Prescription

510(k) clearances

119

Adverse events

Recalls

Facilities

Description

Basic Set for AuDX branded Sentiero Content: - carrying bag A/N100503 - USB cable A/N100089 - AuDX A/N100098-AU - Headphone HB7/DD45 A/N100306-US - Probe EP-DP PATH long A/N100028-US - FW TEOAE Quick A/N100109-QUICK - FW DPOAE Quick A/N100110-QUICK - FW FMDPOAE A/N100536 - FW PTA Class 4 Advanced A/N100653 - FW Magic A/N100112 - FW Mira PC- Software A/N100116 - FW Labelprinter A/N100414 - Accessory box combo A/N100261 - Power Supply Sentiero US A/N100083-US - User Manual A/N100904-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.