Hearing Aid, Air-Conduction, Prescription

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2010-05-26TerminatedProcess design

  InSound Medical, Inc, Lyric in-canal hearing aid.

  Manufacturing error could result in electrolyte leakage from the product's battery.

• TerminatedEmployee error

  Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.

  The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.

• TerminatedOther

  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-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW

  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.

• TerminatedOther

  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

  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.