Siemens Hearing Instruments, Inc.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Siemens Hearing Instruments, Inc.” (first 1984, latest 2007), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 36 | 36 |
| KLW | Masker, Tinnitus | 3 | 3 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 2 | 2 |
| ESF | Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent | 1 | 1 |
Review panels
Most recent Siemens Hearing Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | ETW | 2007-06-05 | 11 |
| K011364 | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) | KLW | 2001-06-07 | 34 |
| K011366 | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | KLW | 2001-06-01 | 28 |
| K003559 | TCI (TINNITUS CONTROL INSTRUMENT) | KLW | 2001-04-26 | 160 |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | ESD | 2001-04-24 | 158 |
| K972998 | PRISMA | ESD | 1997-09-05 | 24 |
| K962170 | SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP | ESD | 1996-07-25 | 50 |
| K952940 | PERSONAL PROGRAMMER 2000 | ESD | 1995-07-26 | 30 |
| K951828 | FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT | ESD | 1995-06-30 | 71 |
| K952263 | PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT | ESD | 1995-06-05 | 21 |
32 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-07-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Siemens Medical Solutions USA, Inc. (784 510(k)s)
- Siemens Healthcare Diagnostics, Inc. (245 510(k)s)
- Siemens Corp. (67 510(k)s)
- Siemens Elema AB (63 510(k)s)
- Siemens Gammasonics, Inc. (53 510(k)s)
- Siemens Medi Cal Solutions, Inc. (32 510(k)s)
- Siemens AG Medical Solutions (31 510(k)s)
- Siemens Healthcare GmbH (31 510(k)s)
- Siemens Medical Systems, Inc. (25 510(k)s)
- Siemens Healthcare Diagnostics Products GmbH (18 510(k)s)
- Siemens AG (15 510(k)s)
- Siemens Medical Electronics (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Hearing Instruments, Inc.?
FDA lists 42 510(k) clearances under the applicant name “Siemens Hearing Instruments, Inc.” (first 1984, latest 2007), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Siemens Hearing Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Hearing Instruments, Inc. is 48 days.
Which FDA product codes appear under Siemens Hearing Instruments, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 36); KLW (Masker, Tinnitus, 3); ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 2).
Next steps
- See all 42 Siemens Hearing Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Siemens Hearing Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.