The Recall Desk
HighFDA (Devices)·Z-0583-2020·Announced 2019-12-04

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

GN Hearing is recalling 590 behind-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 is classified as FDA Class II. The hazard involves a risk of harm (unintended gain affecting residual hearing) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GN Hearing A/S is recalling 590 units of behind-the-Ear hearing aids distributed nationwide. The recall involves specific model numbers including Q962-DRW, T561-DRW, T562-DRW, and others, identified by specific serial numbers listed in the agency record.

The recall was initiated after GN Hearing received reports from its U.S. 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. As a result, users' residual hearing may be exposed to unintended additional available gain, ranging from 18dB flat linear gain to potentially 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
Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-
Manufacturer
GN Hearing A/S
Category
Medical Device — Hearing Aids
Hazard
Affected units
590

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 (19)

  • BTE Model Numbers 1. Q962-DRW
  • Serial Numbers: 1956267136 2. T561-DRW
  • Serial Numbers: 1826333136 3. T562-DRW
  • Serial Numbers: 1926268020 1926268023 4. T762-DRW
  • Serial Numbers: 1786530800 1786530800 1786530800 1786530800 5. T777-DW
  • Serial Numbers: 1856523922 6. AMZ964-DRW
  • Serial Numbers: 1886309928 1886309928 7. ET588-DWH
  • Serial Numbers: 1826694045 1886574434 1926917354 8. ET598-DW
  • Serial Numbers: 1786681686 1949058624 10. ET798-DW
  • Serial Numbers: 1786671213 1826213864 1866083875 11. ET988-DWH
  • Serial Numbers: 1956481867 16. RE762-DRW
  • Serial Numbers: 1950393987 17. RE961-DRWC
  • Serial Numbers: 1886200466 1926008396 18. RE962-DRW
  • Serial Numbers: 1926887334 1926974193 1926974194 20. LT561-DRW
  • Serial Numbers: 1856461081 1956645249 24. LT761-DRW
  • Serial Numbers: 1856789095 28. LT788-DW
  • Serial Numbers: 1886131694 29. LT961-DRW
  • Serial Numbers: 1926274867 33. LT977-DW
  • Serial Numbers: 1726831324 1726831324 1726869590 1856967305 40. VA861-DRW

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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