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GN Hearing A/S recalls In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8I
Recalled December 4, 2019 · FDA recall Z-0584-2020 · GN Hearing A/S
Hazard
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 limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported. · FDA Class II
Units
285 units
Sold at
Nationwide
Description
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 limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported.
Product
In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH-W-HP, FT8MIH-W-MP, LT5CIC-MP, LT5CIC-UP, LT5IIC-LP, LT5ITC-DW-MP, LT5ITC-DW-UP, LT5ITE-DW-HP, LT5ITE-DW-MP, LT5ITE-DW-UP, LT5MIH-W-HP, LT5MIH-W-MP, LT5MIH-W-UP, LT7CIC-HP, LT7CIC-LP, LT7CIC-MP, LT7CIC-W-MP, LT7IIC-LP, LT7ITC-DW-LP, LT7ITC-DW-MP, LT7ITC-MP, LT7ITC-W-HP, LT7ITC-W-MP, LT7ITE-DW-HP, LT7ITE-DW-MP, LT7ITE-DW-UP, LT7ITE-W-UP, LT7MIH-W-HP, LT7MIH-W-LP, LT7MIH-W-MP, LT9CIC-HP, LT9CIC-MP, LT9CIC-W-MP, LT9IIC-LP, LT9ITC-DW-HP, LT9ITC-DW-LP, LT9ITC-DW-MP, LT9ITE-DW-HP, LT9ITE-DW-MP, LT9ITE-DW-UP, LT9MIH-HP, LT9MIH-MP, LT9MIH-W-HP, LT9MIH-W-LP, LT9MIH-W-MP, TST17IIC-LP, TST17ITC-DW-HP, TST17ITE-HP, TST17MIH-W-UP, TST6CIC-HP, TST6IIC-LP, TST6ITC-MP, TST6ITC-W-HP, TST6ITC-W-MP, TST6ITE-DW-UP, TST6ITE-HP, TST6ITE-W-UP, TST6MIH-W-HP, TST9ITC-DW-MP, TST9ITE-DW-HP, TST9ITE-MP, TST9MIH-W-MP, VA8CIC-HP, VA8CIC-MP, VA8IIC-LP, VA8ITC-DW-HP, VA8ITC-DW-MP, VA8ITC-W-MP, VA8ITE-D-HP, VA8ITE-DW-HP, VA8ITE-DW-UP, VA8MIH-W-MP
Manufacturer(s)
GN Hearing A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →