Micro-Ear Technology, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Micro-Ear Technology, Inc.” (first 1993, latest 2004), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 83 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 |
| KLW | Masker, Tinnitus | 1 | 1 |
Review panels
Most recent Micro-Ear Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041302 | REFUGE SOUND GENERATOR | KLW | 2004-07-01 | 48 |
| K972431 | MERIDIAN DSP | ESD | 1997-07-23 | 29 |
| K970880 | POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN | ESD | 1997-06-06 | 88 |
| K964657 | SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF | ESD | 1997-02-11 | 83 |
| K934149 | MICRO-TECH TRU CANAL | ESD | 1993-12-27 | 125 |
Recalls
openFDA lists no recalls under a recalling firm named Micro-Ear Technology, 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.
- Micro-Ear Hearing Center, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micro-Ear Technology, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Micro-Ear Technology, Inc.” (first 1993, latest 2004), across 2 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 Micro-Ear Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro-Ear Technology, Inc. is 83 days.
Which FDA product codes appear under Micro-Ear Technology, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 4); KLW (Masker, Tinnitus, 1).
Next steps
- See all 5 Micro-Ear Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Micro-Ear Technology, 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.