Reported Dec 4, 2019 · Terminated
In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP,…
GN Hearing A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GN Hearing A/S · Lautrupbjerg 7 · Ballerup · N/A
Is this the product you have?
- In-the-Ear hearing aids
- Model Numbers
80 of 80 codes
T9ITC-DW-LPFT6ITC-D-MPFT6ITE-D-MPFT8CIC-MPFT8ITC-W-HPFT8ITC-W-LPFT8ITC-W-MPFT8ITE-DW-HPFT8MIH-W-HPFT8MIH-W-MPLT5CIC-MPLT5CIC-UPLT5IIC-LPLT5ITC-DW-MPLT5ITC-DW-UPLT5ITE-DW-HPLT5ITE-DW-MPLT5ITE-DW-UPLT5MIH-W-HPLT5MIH-W-MPLT5MIH-W-UPLT7CIC-HPLT7CIC-LPLT7CIC-MPLT7CIC-W-MPLT7IIC-LPLT7ITC-DW-LPLT7ITC-DW-MPLT7ITC-MPLT7ITC-W-HPLT7ITC-W-MPLT7ITE-DW-HPLT7ITE-DW-MPLT7ITE-DW-UPLT7ITE-W-UPLT7MIH-W-HPLT7MIH-W-LPLT7MIH-W-MPLT9CIC-HPLT9CIC-MPLT9CIC-W-MPLT9IIC-LPLT9ITC-DW-HPLT9ITC-DW-LPLT9ITC-DW-MPLT9ITE-DW-HPLT9ITE-DW-MPLT9ITE-DW-UPLT9MIH-HPLT9MIH-MPLT9MIH-W-HPLT9MIH-W-LPLT9MIH-W-MPTST17IIC-LPTST17ITC-DW-HPTST17ITE-HPTST17MIH-W-UPTST6CIC-HPTST6IIC-LPTST6ITC-MP
- Lot codes and dates
80 of 80 products
Products covered by this recall # Product as published 1 T9ITC-DW-LP, Serial Numbers: 1803042525 2 FT6ITC-D-MP, Serial Numbers: 1703186476 3 FT6ITE-D-MP, Serial Numbers: 1803046347 4 FT8CIC-MP, Serial Numbers: 1903001780 5 FT8ITC-W-HP, Serial Numbers: 1703204072 6 FT8ITC-W-LP, Serial Numbers: 1803082537 7 FT8ITC-W-MP, Serial Numbers: 1803001903, 1803162395 8 FT8ITE-DW-HP, Serial Numbers: 1803007441 9 FT8MIH-W-HP, Serial Numbers: 1803099905, 1803105154 10 FT8MIH-W-MP, Serial Numbers: 1703187560 1803010468 1803010468 1803050131 1803088032 1803088032 1803088033 1803110197 11 LT5CIC-MP, Serial Numbers: 1703112759 1703112759 1803128423 1903035093 1903035093 1903035093 1903035093 12 LT5CIC-UP, Serial Numbers: 1903067660 13 LT5IIC-LP, Serial Numbers: 1903080274, 1903080275 14 LT5ITC-DW-MP, Serial Numbers: 1703127304 1703130569 1903042498 1903071182 15 LT5ITC-DW-UP, Serial Numbers: 1703170623, 1703170623 16 LT5ITE-DW-HP, Serial Numbers: 1703177839, 1703177839, 1703192785 17 LT5ITE-DW-MP, Serial Numbers: 1703115716 1703115716 1703116332 1703132690 1803138757 1903070073 18 LT5ITE-DW-UP, Serial Numbers: 1803150744, 1803150744 19 LT5MIH-W-HP, Serial Numbers: 1803128733 1903077880 1903077881 1903086704 20 LT5MIH-W-MP, Serial Numbers: 1803049552, 1803049553, 1903064066 - Amount recalled
- 285 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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