Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hearing Aid Co. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905784 | CUSTOM ITE HEARING AID | Hearing Aid Co. | 1991-03-18 | 90 | 0 |
| K881296 | HEARING AID (ALL-IN-THE-EAR) | Hearing Aid Co. | 1988-04-12 | 15 | 0 |
| K802306 | WIDEX HEARING AID #'S A18+T & A18+H | Hearing Aid Co. | 1980-10-10 | 17 | 0 |
| K802307 | WIDEX HEARING AID #'S A12+T & A12+H | Hearing Aid Co. | 1980-10-10 | 17 | 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