Bosch Hearing Instruments, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Bosch Hearing Instruments, Inc.” (first 1980, latest 1985), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 57 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 | 4 | 4 |
| DPS | Electrocardiograph | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Review panels
Most recent Bosch Hearing Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840571 | EKG 503A | DPS | 1985-12-30 | 691 |
| K840569 | EKG 501 A | DPS | 1985-12-30 | 691 |
| K840574 | EBM-500 | DXN | 1985-11-14 | 645 |
| K822579 | BOSCH STAR 66F-SP HEARING AID | ESD | 1982-09-30 | 36 |
| K820041 | BOSCH TOP STAR III | ESD | 1982-01-22 | 15 |
| K810347 | BOSCH STAR 66F SUPER EARLEVEL AID | ESD | 1981-03-31 | 49 |
| K800779 | OMNITON MT80-A BODY HEARING AID | ESD | 1980-06-04 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Bosch Hearing Instruments, Inc..
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.
- Bosch Healthcare Solutions GmbH (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bosch Hearing Instruments, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Bosch Hearing Instruments, Inc.” (first 1980, latest 1985), across 3 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 Bosch Hearing Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bosch Hearing Instruments, Inc. is 57 days.
Which FDA product codes appear under Bosch Hearing Instruments, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 4); DPS (Electrocardiograph, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Next steps
- See all 7 Bosch Hearing Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Bosch 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.