Medical Device Manufacturer · US , Mchenry , IL

Siemens Hearing Instruments, Inc.

42 submissions · 42 cleared · Since 1984
42
Total
42
Cleared
0
Denied

Siemens Hearing Instruments, Inc. — FDA 510(k) Submissions

Siemens Hearing Instruments, Inc. has submitted 42 FDA 510(k) premarket notifications since 1984, of which 42 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hearing Aid, Air-conduction, Prescription, Masker, Tinnitus, Calibrator, Hearing Aid / Earphone And Analysis Systems, Polymer, Composite Synthetic Ptfe With Carbon-fiber, Ent . Use the specialty filter in the sidebar to narrow results.

42 devices
1–25 of 42
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
Jun 2007 11d
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · KLW Masker, Tinnitus · Ear, Nose, Throat
Jun 2001 34d
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · KLW Masker, Tinnitus · Ear, Nose, Throat
Jun 2001 28d
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · KLW Masker, Tinnitus · Ear, Nose, Throat
Apr 2001 160d
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558 · ESD Hearing Aid,... · Ear, Nose, Throat
Apr 2001 158d
PRISMA
K972998 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1997 24d
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
K962170 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1996 50d
PERSONAL PROGRAMMER 2000
K952940 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1995 30d
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
K951828 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1995 71d
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
K952263 · ESD Hearing Aid,... · Ear, Nose, Throat
Jun 1995 21d
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
K951896 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1995 36d
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE
K952098 · ETW Calibrator, Hearing Aid /... · Ear, Nose, Throat
May 1995 21d
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
K943380 · ESD Hearing Aid,... · Ear, Nose, Throat
Jan 1995 176d
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944174 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1994 123d
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944645 · ESD Hearing Aid,... · Ear, Nose, Throat
Dec 1994 97d
SIEMENS MODEL 584 P-2
K934752 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1994 338d
INFINITY 252
K935019 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1994 322d
SIEMENS BTE HEARING AIDS
K942857 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1994 67d
SIEMENS MODEL 584-P-GC
K930998 · ESD Hearing Aid,... · Ear, Nose, Throat
Apr 1993 45d
SIEMENS MODEL 584-P-AI
K930999 · ESD Hearing Aid,... · Ear, Nose, Throat
Apr 1993 45d
SIEMENS MODEL 584-P-AI-D
K931000 · ESD Hearing Aid,... · Ear, Nose, Throat
Apr 1993 45d
SIEMENS MODEL INFINITI 1001 B
K923379 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1992 40d
SIEMENS MODEL TRITON 3004 B
K923380 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1992 40d
LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE
K921656 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1992 31d
SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION
K914333 · ESD Hearing Aid,... · Ear, Nose, Throat
Oct 1991 14d
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