Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hearing Innovations, 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) |
|---|---|---|---|---|---|
| K013253 | HISONIC-TRD TINNITUS RELIEF DEVICE | Hearing Innovations, Inc. | 2002-04-05 | 189 | 0 |
| K963745 | MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) | Hearing Innovations, Inc. | 1996-11-26 | 70 | 0 |
| K951678 | HI SONIC 2000 DIGITAL HEARING INSTRUMENT | Hearing Innovations, Inc. | 1995-06-07 | 57 | 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