Midwest City Hearing Aid Center: FDA clearances and approvals
Midwest City Hearing Aid Center has 12 FDA 510(k) clearances (first 1995, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time: 32 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 | 12 | 12 |
Review panels
- Ear, Nose and Throat (12)
Most recent Midwest City Hearing Aid Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970430 | ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI | ESD | 1997-03-11 | 35 |
| K963604 | DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION | ESD | 1996-09-27 | 18 |
| K963607 | HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL | ESD | 1996-09-20 | 11 |
| K953729 | K AMP FULL SHELL AND IN THE EAR | ESD | 1995-09-12 | 33 |
| K953728 | RX12 LINEAR FULL SHELL AND IN THE CANAL | ESD | 1995-09-12 | 33 |
| K953631 | SNIP INPUT COMPRESSION CLASS A | ESD | 1995-08-28 | 42 |
| K952986 | SPI-SECRET PERSONAL INSTRUMENT CIC | ESD | 1995-08-07 | 40 |
| K953038 | DYNAMIC EQ/CLASS D | ESD | 1995-07-21 | 32 |
| K953036 | DB PUSH-PULL HEARING AID | ESD | 1995-07-21 | 32 |
| K952821 | MWCHAC 95 FS 12345 | ESD | 1995-07-21 | 31 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Midwest City Hearing Aid Center.
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 Midwest City Hearing Aid Center have?
Midwest City Hearing Aid Center has 12 FDA 510(k) clearances (first 1995, latest 1997), across 1 product code in 1 review panel.
How long does FDA take to clear Midwest City Hearing Aid Center's 510(k)s?
The median time from FDA receipt to decision across Midwest City Hearing Aid Center's cleared 510(k)s is 32 days.
What devices does Midwest City Hearing Aid Center make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 12).
Has Midwest City Hearing Aid Center had device recalls?
openFDA lists no recalls under a recalling firm name matching Midwest City Hearing Aid Center. Related entities may recall under other names.
Next steps
- See all 12 Midwest City Hearing Aid Center clearances with predicates and recalls
- Run predicate analysis for product code ESD, Midwest City Hearing Aid Center'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.