Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hearing Solutions, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
99 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964180 | AUDIO 'D' SOUND SELECTOR POWER (SSP) | Hearing Solutions, Inc. | 1996-11-26 | 39 | 0 |
| K962798 | AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS | Hearing Solutions, Inc. | 1996-09-09 | 53 | 0 |
| K961308 | AUDIO 'D' INTIMA CIC | Hearing Solutions, Inc. | 1996-05-07 | 33 | 0 |
| K960935 | AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL I | Hearing Solutions, Inc. | 1996-04-03 | 26 | 0 |
| K944980 | SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM) | Hearing Solutions, Inc. | 1995-01-18 | 99 | 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