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RXEars

Persona Medical · Model RXi · UDI-DI 00851362008339

ESD

510(k) clearances

673

Adverse events (2 deaths)

Recalls

102

Facilities

Description

This is a stock/universal fit hearing aid similar in size to a CIC (Custom In the Canal) . The device is used for mild to moderate hearing loss. This is non-programmable in the field and adjustments ONLY made by the factory for a patient's hearing loss and related factors.

Recalls

Date	Firm	Reason
2019-09-18	GN Hearing A/S	GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a lim
2019-09-18	GN Hearing A/S	GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a lim
2018-08-31	Widex A/S	The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resi
2010-01-19	InSound Medical, Inc.	Manufacturing error could result in electrolyte leakage from the product's battery.

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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.