Company ยท US
Siemens Hearing Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2007. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2007 | K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) Siemens Hearing Instruments, Inc. | ETW |
| Jun 7, 2001 | K011364 | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) Siemens Hearing Instruments, Inc. | KLW |
| Jun 1, 2001 | K011366 | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) Siemens Hearing Instruments, Inc. | KLW |
| Apr 26, 2001 | K003559 | TCI (TINNITUS CONTROL INSTRUMENT) Siemens Hearing Instruments, Inc. | KLW |
| Apr 24, 2001 | K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) Siemens Hearing Instruments, Inc. | ESD |
| Sep 5, 1997 | K972998 | PRISMA Siemens Hearing Instruments, Inc. | ESD |
| Jul 25, 1996 | K962170 | SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP Siemens Hearing Instruments, Inc. | ESD |
| Jul 26, 1995 | K952940 | PERSONAL PROGRAMMER 2000 Siemens Hearing Instruments, Inc. | ESD |
| Jun 30, 1995 | K951828 | FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT Siemens Hearing Instruments, Inc. | ESD |
| Jun 5, 1995 | K952263 | PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT Siemens Hearing Instruments, Inc. | ESD |
| May 30, 1995 | K951896 | INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT Siemens Hearing Instruments, Inc. | ESD |
| May 25, 1995 | K952098 | SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE Siemens Hearing Instruments, Inc. | ETW |
| Jan 5, 1995 | K943380 | SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS Siemens Hearing Instruments, Inc. | ESD |
| Dec 27, 1994 | K944645 | SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS Siemens Hearing Instruments, Inc. | ESD |
| Dec 27, 1994 | K944174 | LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS Siemens Hearing Instruments, Inc. | ESD |
| Sep 7, 1994 | K935019 | INFINITY 252 Siemens Hearing Instruments, Inc. | ESD |
| Sep 7, 1994 | K934752 | SIEMENS MODEL 584 P-2 Siemens Hearing Instruments, Inc. | ESD |
| Aug 22, 1994 | K942857 | SIEMENS BTE HEARING AIDS Siemens Hearing Instruments, Inc. | ESD |
| Apr 12, 1993 | K931000 | SIEMENS MODEL 584-P-AI-D Siemens Hearing Instruments, Inc. | ESD |
| Apr 12, 1993 | K930999 | SIEMENS MODEL 584-P-AI Siemens Hearing Instruments, Inc. | ESD |
| Apr 12, 1993 | K930998 | SIEMENS MODEL 584-P-GC Siemens Hearing Instruments, Inc. | ESD |
| Aug 18, 1992 | K923380 | SIEMENS MODEL TRITON 3004 B Siemens Hearing Instruments, Inc. | ESD |
| Aug 18, 1992 | K923379 | SIEMENS MODEL INFINITI 1001 B Siemens Hearing Instruments, Inc. | ESD |
| May 8, 1992 | K921656 | LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE Siemens Hearing Instruments, Inc. | ESD |
| Oct 11, 1991 | K914333 | SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION Siemens Hearing Instruments, Inc. | ESD |
| Jun 26, 1991 | K911811 | SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID Siemens Hearing Instruments, Inc. | ESD |
| Jun 26, 1991 | K911810 | SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID Siemens Hearing Instruments, Inc. | ESD |
| Oct 5, 1990 | K903760 | MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM Siemens Hearing Instruments, Inc. | ESD |
| May 21, 1990 | K893576 | SIEMENS MODEL 284 PP Siemens Hearing Instruments, Inc. | ESD |
| May 21, 1990 | K893575 | SIEMENS MODEL 283 ASP Siemens Hearing Instruments, Inc. | ESD |
| May 21, 1990 | K893574 | SIEMENS MODEL 284 PP-AGC Siemens Hearing Instruments, Inc. | ESD |
| May 21, 1990 | K893573 | SIEMENS MODEL 284 PP-L Siemens Hearing Instruments, Inc. | ESD |
| Mar 31, 1989 | K891251 | BEHIND-THE-EAR HEARING AID MODEL 408 W-H Siemens Hearing Instruments, Inc. | ESD |
| Mar 29, 1989 | K891250 | BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC Siemens Hearing Instruments, Inc. | ESD |
| Mar 29, 1989 | K891249 | BEHIND-THE-EAR HEARING AID MODEL 303 ASP Siemens Hearing Instruments, Inc. | ESD |
| Mar 29, 1989 | K891248 | BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I Siemens Hearing Instruments, Inc. | ESD |
| Mar 29, 1989 | K891247 | BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC Siemens Hearing Instruments, Inc. | ESF |
| Jan 18, 1989 | K884583 | BTE HEARING AID SIEMENS MODEL 284PP-ASP Siemens Hearing Instruments, Inc. | ESD |
| Sep 22, 1988 | K882678 | ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS Siemens Hearing Instruments, Inc. | ESD |
| Aug 11, 1987 | K872152 | SIEMENS SILICONE IMPRESSION MATERIAL Siemens Hearing Instruments, Inc. | ESD |
| Aug 2, 1984 | K840893 | CONFERETTE C2 Siemens Hearing Instruments, Inc. | ESD |
| Mar 30, 1984 | K833773 | CANAL HEARING AID Siemens Hearing Instruments, Inc. | ESD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2014 | Siemens Hearing Instruments, Inc Siemens Prisma 2K Hearing Aid
Product Usage:
A behind the ear (BTE) hearing aid developed for pediatric patients. Terminated |
LEZ | None listed |