Manufacturer according to FDA:
Manufacturer according to EU
Medical Device Regulation
2017/745 and Health Canada:
GNHearingA/S
Lautrupbjerg 7
DK-2750 Ballerup
Denmark
GNHearing
8001 E Bloomington Freeway
Bloomington, MN 55420
USA
Any serious incident that has occurred in relation to the device should be reported to the legal
manufacturer GNHearingA/S and the competent authority of the EU Member State in which the user
and/or patient is established.
401816011US_CA- 24.07 - Rev. D (Date of issuance:2024.07.01)