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Persona Medical

Persona Medical · Model Sombra 9R · UDI-DI 00851362008520

ESD Prescription

510(k) clearances

673

Adverse events (2 deaths)

Recalls

102

Facilities

Description

RIC/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used to mitigate mild to severe hearing losses and can be programmed with software to tailor to user needs.

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.