The Recall Desk
HighFDA (Devices)·Z-0584-2020·Announced 2019-12-04

GN Hearing Recalls In-the-Ear Hearing Aids Due to Software Bug

GN Hearing is recalling 285 in-the-ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (hearing aids) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

GN Hearing A/S is recalling 285 units of in-the-ear hearing aids distributed nationwide. The recall involves specific model numbers and serial numbers listed in the agency's structured product information.

The recall was initiated after GN Hearing received reports from its US manufacturing site regarding a software bug in a service and repair tool. This bug affected the capture and restoration of user data in a limited number of repaired hearing aids, causing them to contain altered specifications for sound amplification. This alteration potentially puts users' residual hearing at risk of experiencing unintended additional available gain, ranging from 18dB flat linear gain to Full On Gain in the worst case. No injuries have been reported.

Consumers with affected hearing aids should contact GN Hearing for further instructions on how to resolve the issue.

The recalled product

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-
Manufacturer
GN Hearing A/S
Category
Medical Device — Hearing Aids
Hazard
Affected units
285

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • ITE Model Numbers 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: 1903067660 13. LT5IIC-LP
  • Serial Numbers: 1903080274
  • 1903080275 14. LT5ITC-DW-MP
  • Serial Numbers: 1703170623
  • 1703170623 16. LT5ITE-DW-HP
  • Serial Numbers: 1703177839
  • 1703177839
  • 1703192785 17. LT5ITE-DW-MP

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GN Hearing A/S under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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