Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
National Hearing Aid Dist., Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971296 | TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03 | National Hearing Aid Dist., Inc. | 1997-06-20 | 74 | 0 |
| K952057 | LISTENAIDER II | National Hearing Aid Dist., Inc. | 1995-06-21 | 50 | 0 |
| K935458 | AUDIPHON, MODEL H-11 | National Hearing Aid Dist., Inc. | 1994-01-05 | 54 | 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