Miracle-Ear/Dahlberg, Inc.: FDA clearances and approvals
Miracle-Ear/Dahlberg, Inc. has 23 FDA 510(k) clearances (first 1985, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time: 58 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 | 22 | 22 |
| EWO | Audiometer | 1 | 1 |
Review panels
- Ear, Nose and Throat (23)
Most recent Miracle-Ear/Dahlberg, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942895 | MIRACLE EAR MODEL PGM | ESD | 1994-08-17 | 58 |
| K942894 | MIRACLE-EAR MODEL PGC | ESD | 1994-08-17 | 58 |
| K942893 | MIRACLE-EAR MODEL PGF + REMOTE | ESD | 1994-08-17 | 58 |
| K941859 | MIRACLE-EAR EAR IMPRESSION MATERIAL | ESD | 1994-07-25 | 101 |
| K862104 | MODEL UC SPECTRUM IN-THE-CANAL HEARING AID | ESD | 1986-06-23 | 21 |
| K862103 | MODEL UC IN-THE-CANAL HEARING AID | ESD | 1986-06-23 | 21 |
| K862102 | MODEL KM IN-THE-CANAL HEARING AID | ESD | 1986-06-23 | 21 |
| K862101 | MODEL UM IN-THE-CANAL HEARING AID | ESD | 1986-06-23 | 21 |
| K862100 | MODEL ED BEHIND-THE-EAR HEARING AID | ESD | 1986-06-23 | 21 |
| K862099 | DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID | ESD | 1986-06-23 | 21 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Miracle-Ear/Dahlberg, 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/Dahlberg, Inc. have?
Miracle-Ear/Dahlberg, Inc. has 23 FDA 510(k) clearances (first 1985, latest 1994), across 2 product codes in 1 review panel.
How long does FDA take to clear Miracle-Ear/Dahlberg, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Miracle-Ear/Dahlberg, Inc.'s cleared 510(k)s is 58 days.
What devices does Miracle-Ear/Dahlberg, Inc. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 22); EWO (Audiometer, 1).
Has Miracle-Ear/Dahlberg, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Miracle-Ear/Dahlberg, Inc. Related entities may recall under other names.
Next steps
- See all 23 Miracle-Ear/Dahlberg, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Miracle-Ear/Dahlberg, 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.