Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siemens Hearing Instruments, Inc. — Predicate Candidate Screening
42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
338 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | Siemens Hearing Instruments, Inc. | 2007-06-05 | 11 | 0 |
| K011364 | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) | Siemens Hearing Instruments, Inc. | 2001-06-07 | 34 | 0 |
| K011366 | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | 2001-06-01 | 28 | 0 |
| K003559 | TCI (TINNITUS CONTROL INSTRUMENT) | Siemens Hearing Instruments, Inc. | 2001-04-26 | 160 | 0 |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | 2001-04-24 | 158 | 0 |
| K972998 | PRISMA | Siemens Hearing Instruments, Inc. | 1997-09-05 | 24 | 0 |
| K962170 | SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E | Siemens Hearing Instruments, Inc. | 1996-07-25 | 50 | 0 |
| K952940 | PERSONAL PROGRAMMER 2000 | Siemens Hearing Instruments, Inc. | 1995-07-26 | 30 | 0 |
| K951828 | FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRU | Siemens Hearing Instruments, Inc. | 1995-06-30 | 71 | 0 |
| K952263 | PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING | Siemens Hearing Instruments, Inc. | 1995-06-05 | 21 | 0 |
| K951896 | INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION B | Siemens Hearing Instruments, Inc. | 1995-05-30 | 36 | 0 |
| K952098 | SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MO | Siemens Hearing Instruments, Inc. | 1995-05-25 | 21 | 0 |
| K943380 | SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS | Siemens Hearing Instruments, Inc. | 1995-01-05 | 176 | 0 |
| K944645 | SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SIT | Siemens Hearing Instruments, Inc. | 1994-12-27 | 97 | 0 |
| K944174 | LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE IN | Siemens Hearing Instruments, Inc. | 1994-12-27 | 123 | 0 |
| K935019 | INFINITY 252 | Siemens Hearing Instruments, Inc. | 1994-09-07 | 322 | 0 |
| K934752 | SIEMENS MODEL 584 P-2 | Siemens Hearing Instruments, Inc. | 1994-09-07 | 338 | 0 |
| K942857 | SIEMENS BTE HEARING AIDS | Siemens Hearing Instruments, Inc. | 1994-08-22 | 67 | 0 |
| K930999 | SIEMENS MODEL 584-P-AI | Siemens Hearing Instruments, Inc. | 1993-04-12 | 45 | 0 |
| K930998 | SIEMENS MODEL 584-P-GC | Siemens Hearing Instruments, Inc. | 1993-04-12 | 45 | 0 |
| K931000 | SIEMENS MODEL 584-P-AI-D | Siemens Hearing Instruments, Inc. | 1993-04-12 | 45 | 0 |
| K923379 | SIEMENS MODEL INFINITI 1001 B | Siemens Hearing Instruments, Inc. | 1992-08-18 | 40 | 0 |
| K923380 | SIEMENS MODEL TRITON 3004 B | Siemens Hearing Instruments, Inc. | 1992-08-18 | 40 | 0 |
| K921656 | LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE | Siemens Hearing Instruments, Inc. | 1992-05-08 | 31 | 0 |
| K914333 | SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION | Siemens Hearing Instruments, Inc. | 1991-10-11 | 14 | 0 |
| K911811 | SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID | Siemens Hearing Instruments, Inc. | 1991-06-26 | 64 | 0 |
| K911810 | SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID | Siemens Hearing Instruments, Inc. | 1991-06-26 | 64 | 0 |
| K903760 | MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM | Siemens Hearing Instruments, Inc. | 1990-10-05 | 46 | 0 |
| K893573 | SIEMENS MODEL 284 PP-L | Siemens Hearing Instruments, Inc. | 1990-05-21 | 377 | 0 |
| K893575 | SIEMENS MODEL 283 ASP | Siemens Hearing Instruments, Inc. | 1990-05-21 | 377 | 0 |
| K893574 | SIEMENS MODEL 284 PP-AGC | Siemens Hearing Instruments, Inc. | 1990-05-21 | 377 | 0 |
| K893576 | SIEMENS MODEL 284 PP | Siemens Hearing Instruments, Inc. | 1990-05-21 | 377 | 0 |
| K891251 | BEHIND-THE-EAR HEARING AID MODEL 408 W-H | Siemens Hearing Instruments, Inc. | 1989-03-31 | 23 | 0 |
| K891249 | BEHIND-THE-EAR HEARING AID MODEL 303 ASP | Siemens Hearing Instruments, Inc. | 1989-03-29 | 21 | 0 |
| K891247 | BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC | Siemens Hearing Instruments, Inc. | 1989-03-29 | 21 | 0 |
| K891248 | BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I | Siemens Hearing Instruments, Inc. | 1989-03-29 | 21 | 0 |
| K891250 | BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC | Siemens Hearing Instruments, Inc. | 1989-03-29 | 21 | 0 |
| K884583 | BTE HEARING AID SIEMENS MODEL 284PP-ASP | Siemens Hearing Instruments, Inc. | 1989-01-18 | 77 | 0 |
| K882678 | ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS | Siemens Hearing Instruments, Inc. | 1988-09-22 | 86 | 0 |
| K872152 | SIEMENS SILICONE IMPRESSION MATERIAL | Siemens Hearing Instruments, Inc. | 1987-08-11 | 68 | 0 |
| K840893 | CONFERETTE C2 | Siemens Hearing Instruments, Inc. | 1984-08-02 | 157 | 0 |
| K833773 | CANAL HEARING AID | Siemens Hearing Instruments, Inc. | 1984-03-30 | 155 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda