Hearing Solutions, Inc.: FDA clearances and approvals
Hearing Solutions, Inc. has 5 FDA 510(k) clearances (first 1995, latest 1996), across 1 product code in 1 review panel. Median 510(k) review time: 39 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 5 | 5 |
Review panels
Most recent Hearing Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964180 | AUDIO 'D' SOUND SELECTOR POWER (SSP) | ESD | 1996-11-26 | 39 |
| K962798 | AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS | ESD | 1996-09-09 | 53 |
| K961308 | AUDIO 'D' INTIMA CIC | ESD | 1996-05-07 | 33 |
| K960935 | AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL) | ESD | 1996-04-03 | 26 |
| K944980 | SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM) | ESD | 1995-01-18 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Hearing Solutions, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hearing Solutions, Inc. have?
Hearing Solutions, Inc. has 5 FDA 510(k) clearances (first 1995, latest 1996), across 1 product code in 1 review panel.
How long does FDA take to clear Hearing Solutions, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hearing Solutions, Inc.'s cleared 510(k)s is 39 days.
What devices does Hearing Solutions, Inc. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 5).
Has Hearing Solutions, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hearing Solutions, Inc. Related entities may recall under other names.
Next steps
- See all 5 Hearing Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Hearing Solutions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.