Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hearing Aid Express — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
99 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942829 | HAE 1 | Hearing Aid Express | 1994-07-20 | 36 | 0 |
| K942830 | HAE 3 | Hearing Aid Express | 1994-07-20 | 36 | 0 |
| K942831 | HAE 2 | Hearing Aid Express | 1994-07-20 | 36 | 0 |
| K894428 | HEARING AID (IN-THE-EAR) | Hearing Aid Express | 1989-10-24 | 99 | 0 |
| K894414 | HEARING AID (IN-THE-CANAL) | Hearing Aid Express | 1989-09-27 | 72 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda