Miracle-Ear, Inc.: FDA clearances and approvals
Miracle-Ear, Inc. has 65 FDA 510(k) clearances (first 1990, latest 1997), across 2 product codes in 2 review panels. Median 510(k) review time: 42 days.
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 | 64 | 64 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- Ear, Nose and Throat (64)
- General Hospital (1)
Most recent Miracle-Ear, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972346 | MIRACLE-EAR ITE DIGITAL | ESD | 1997-07-23 | 29 |
| K972345 | DAHLBERG/MIRACLE-EAR | ESD | 1997-07-23 | 29 |
| K972344 | MIRACLE-EAR DIGITAL BTE | ESD | 1997-07-23 | 29 |
| K970262 | MULTI-CHANNEL COMPRESSION BTE (SD) | ESD | 1997-03-31 | 67 |
| K964419 | MIRACLE - EAR (ITE/ITC/CIC) | ESD | 1997-02-04 | 126 |
| K965063 | AUDIOTONE (A-552) | ESD | 1997-01-27 | 40 |
| K965057 | AUDIOTONE (A554H) | ESD | 1997-01-27 | 40 |
| K965049 | DAHLBERG (A-554) | ESD | 1997-01-27 | 40 |
| K964669 | MIRACLE-EAR OR AUDIOTONE | ESD | 1996-12-26 | 35 |
| K964794 | DAHLBERG K-AMP BTE | ESD | 1996-12-23 | 24 |
55 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Miracle-Ear, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Miracle-Ear, Inc. have?
Miracle-Ear, Inc. has 65 FDA 510(k) clearances (first 1990, latest 1997), across 2 product codes in 2 review panels.
How long does FDA take to clear Miracle-Ear, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Miracle-Ear, Inc.'s cleared 510(k)s is 42 days.
What devices does Miracle-Ear, Inc. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 64); LYY (Latex Patient Examination Glove, 1).
Has Miracle-Ear, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Miracle-Ear, Inc. Related entities may recall under other names.
Next steps
- See all 65 Miracle-Ear, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Miracle-Ear, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.