BEUDAMED
    12 results · 86ms · Sources: EU EUDAMED, US FDA

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    Zinc/Air Hearing Aid Batteries

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·VARTA Microbattery GmbH·331 devices

    GN RESOUND

    FDA Adverse Event
    Malfunction ·GN HEARING A/S·Product code OSM·February 14, 2025

    Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.

    FDA Enforcement
    Class II ·Terminated·Widex A/S·October 17, 2018

    PHONAK

    FDA Adverse Event
    Injury ·SONOVA AG·Product code ESD·July 20, 2023

    Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.

    FDA Recall
    Terminated ·Widex A/S Nymollevej 6 Lynge Denmark·Product code ESD·August 31, 2018

    GN RESOUND

    FDA Adverse Event
    Injury ·GN HEARING A/S·Product code OSM·March 6, 2026

    BELTONE

    FDA Adverse Event
    Malfunction ·GN HEARING A/S·Product code OSM·November 25, 2022

    WIDEX

    FDA Adverse Event
    Injury ·INTEGRATED MICRO-ELECTRONICS INC.·Product code OSM·May 17, 2024

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·September 21, 2022

    KE398-DW,KEY 3,GN RESOUND

    FDA Adverse Event
    Malfunction ·GN HEARING A/S·Product code OSM·July 1, 2022

    PHONAK LYRIC4

    FDA Adverse Event
    Injury ·SONOVA AG·Product code ESD·July 25, 2025

    PHONAK SKY L-UP

    FDA Adverse Event
    Injury ·SONOVA AG·Product code OSM·March 24, 2025