Maico Hearing Instruments, Inc.: FDA filings under this applicant name
FDA lists 58 510(k) clearances under the applicant name “Maico Hearing Instruments, Inc.” (first 1977, latest 1996), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 33 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 | 31 | 31 |
| EWO | Audiometer | 20 | 20 |
| ETY | Tester, Auditory Impedance | 5 | 5 |
| LRB | Face Plate Hearing Aid | 2 | 2 |
Review panels
- Ear, Nose and Throat (58)
Most recent Maico Hearing Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960031 | AUDIOFLEX 120 | ESD | 1996-03-07 | 65 |
| K954054 | MAICO PRODIGY CIC SERIES | ESD | 1995-09-28 | 30 |
| K953161 | MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION | ETY | 1995-07-24 | 17 |
| K950637 | MAICO IN-THE-EAR MODEL RD-312 CIC | ESD | 1995-03-21 | 36 |
| K946253 | MAICO IN-THE-EAR MODEL RD 201 | ESD | 1995-01-30 | 38 |
| K931322 | KS 5 - CLINICAL AUDIOMETER | EWO | 1994-08-19 | 521 |
| K933291 | MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID | ESD | 1993-08-23 | 48 |
| K930112 | MAICO MA790 AUDIOMETER | EWO | 1993-08-05 | 206 |
| K926439 | MA25 - PORTABLE AUDIOMETER, MODIFICATION | EWO | 1993-08-05 | 225 |
| K931161 | SERIES STAR 22 - BEHIND THE EAR HEARING AID | ESD | 1993-06-01 | 85 |
48 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Maico 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.
- Maico Diagnostics GmbH (3 510(k)s)
- Maico Diagnostic GmbH (1 510(k)s)
- Maico Diagnostics (Diagnostic Group, LLC) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Maico Hearing Instruments, Inc.?
FDA lists 58 510(k) clearances under the applicant name “Maico Hearing Instruments, Inc.” (first 1977, latest 1996), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Maico Hearing Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maico Hearing Instruments, Inc. is 33 days.
Which FDA product codes appear under Maico Hearing Instruments, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 31); EWO (Audiometer, 20); ETY (Tester, Auditory Impedance, 5).
Next steps
- See all 58 Maico Hearing Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Maico 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.