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Panels › Ear, Nose, Throat › Product code ESD · Class 1

Hearing Aid, Air-Conduction, Prescription

Regulation 874.3300

0510(k)s in 12 months (1,367 all time)

0recalls in 12 months (4 all time)

1recalls that name a 510(k)

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Top companies in ESD

Company	510(k)s	Recalls
Unitron Industries, Inc.	69	0
Miracle-Ear, Inc.	64	0
Electone, Inc.	63	0
Oticon Corp.	63	0
Widex Hearing Aid Co., Inc.	51	0
Rion Acoustic Instruments, Inc.	47	0
Starkey Laboratories, Inc.	39	0
Telex Communications, Inc.	39	0
Phonak, Inc.	37	0
Beltone Electronics Corp.	36	0

Date	Firm and product	Code	Linked 510(k)
Sep 18, 2019	GN Hearing A/S 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-L Terminated	ESD	None listed
Sep 18, 2019	GN Hearing A/S 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-DR Terminated	ESD	None listed
Aug 31, 2018	Widex A/S 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 conduc Terminated	ESD	None listed
May 26, 2010	InSound Medical, Inc. InSound Medical, Inc, Lyric in-canal hearing aid. Terminated	ESD	K081136

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