Hearing Aid, Air-conduction, Prescription
Ear, Nose, Throat · 21 CFR 874.3300
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
Recent MDR events
673 adverse event reports on file
- REXTON REACH INOX-CIC LIJul 20, 2026MalfunctionWs Audiology Usa, Inc.MW5190843
- PHONAK LYRIC4Jun 29, 2026InjurySonova Ag3008848788-2026-00008
- AUDIEN ATOM PRO 2Jun 23, 2026InjuryAudien Hearing / Budget Hearing Aids Llc.MW5189785
- AUDIEN ATOM PRO 2Jun 23, 2026InjuryAudien Hearing / Budget Hearing Aids Llc.MW5189786
- PHONAK LYRIC4Jun 22, 2026InjurySonova Ag3005085999-2026-00014
- PHONAK LYRIC4Jun 8, 2026InjurySonova Ag3005085999-2026-00013
- PHONAK LYRIC4 (L)Jun 8, 2026InjurySonova Ag3008848788-2026-00007
- PHONAK LYRIC4 (L)May 27, 2026InjurySonova Ag3005085999-2026-00011
- PHONAK LYRIC4 (L)May 22, 2026InjurySonova Ag3008848788-2026-00006
- PHONAK LYRIC4 (L)May 21, 2026InjurySonova Ag3005085999-2026-00009
Event type breakdown
Recalls
4 recall events for this product code
- InSound Medical, Inc.TerminatedMay 26, 2010
InSound Medical, Inc, Lyric in-canal hearing aid.
Manufacturing error could result in electrolyte leakage from the product's battery.
Z-1681-2010 · View FDA record ↗ - Widex A/STerminatedUnknown
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10
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.
Z-0094-2019 · View FDA record ↗ - GN Hearing A/STerminatedUnknown
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, E
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.
Z-0583-2020 · View FDA record ↗ - GN Hearing A/STerminatedUnknown
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, FT8
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.
Z-0584-2020 · View FDA record ↗
Registered firms
111 firms currently registered for this product code
Gn Resound China, Ltd.
XIAMEN Fujian, CN
Shenzhen Shenrui Medical Co. Ltd
Shenzhen Guangdong, CN
Dreve Otoplastik Gmbh
UNNA North Rhine-Westphalia, DE
Unitron Hearing, A Division Of National Hearing Services Inc.
KITCHENER Ontario, CA
Kangfu Medical Equipment Factory
Wenzhou Zhejiang, CN
Starkey (suzhou) Hearing Technology Co, Ltd.
Guoxiang, Wuzhong District, Suzhou Jiangsu, CN
Sonova Usa Inc.
Aurora, IL, US
Guangzhou New Design Biotechnology Co., Ltd.
Guangzhou Guangdong, CN
Oticon A/s
Smorum Hovedstaden, DK
Shenzhen Tonycore Technology Co.,ltd.
Shenzhen Guangdong, CN
Ear Technology Corporation
Johnson City, TN, US
Sonova Operations Center Vietnam Company Ltd
Ho Chi Minh City, VN
Magnatone Hearing Aid Corp. Dba Persona Medical
Casselberry, FL, US
Health Source Medical Equipment (guangdong) Ltd.
Foshan Guangdong, CN
Mg Developpement
mauguio Herault, FR
Oticon, Inc.
SOMERSET, NJ, US
Gn Resound (malaysia) Sdn. Bhd
Senai Johor, MY
Detax Gmbh
ETTLINGEN Baden-Wurttemberg, DE
Huizhou Gold Rose Technology Co.,ltd
huizhou Guangdong, CN
Ws Audiology A/s
Lynge Hovedstaden, DK
Ws Audiology Usa, Inc.
Hauppauge, NY, US
Kunwei Medical Electronics Co.,ltd
Shenzhen Guangdong, CN
Xiamen Newsound Technology Co., Ltd
Xiamen Fujian, CN
Shandong Huge Dental Material Corporation
Rizhao Shandong, CN
510(k) clearances
1,367 clearances for this product code
- Sonova AGApr 11, 2024
K232999 · Lyric4 Hearing Aid
- Phonak, LLCJun 27, 2013
K130790 · LYRIC2
- Insound Medical, Inc.May 8, 2008
K081136 · LYRIC HEARING AID
- Insound Medical, Inc.Nov 19, 2002
K021867 · INSOUND XT SERIES HEARING AID
- Siemens Hearing Instruments, Inc.Apr 24, 2001
K003558 · TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
- Sonic Innovations, Inc.Mar 12, 1999
K984518 · SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
- General Hearing Instruments, Inc.Mar 6, 1998
K974751 · TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
- Argosy ElectronicsJan 20, 1998
K974242 · ARGOSY PROGRAMMABLE ONQUE