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GN Hearing A/S

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0583-2020Class IIBehind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964September 18, 2019
Z-0584-2020Class IIIn-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HSeptember 18, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K213424Jabra Enhance PlusJanuary 19, 2022
K193303Tinnitus Sound Generator ModuleFebruary 20, 2020
K180495Tinnitus Sound Generator ModuleNovember 30, 2018
K181586Tinnitus Sound Generator ModuleJuly 13, 2018