Earlens Corporation: FDA clearances and approvals
Earlens Corporation has 2 FDA 510(k) clearances (first 2016, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 124 days. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 110 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 137 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Earlens Corporation's cleared 510(k)s took a median 137 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PLK | Tympanic Membrane Direct Contact Hearing Aid | 3 | 2 |
Review panels
Most recent Earlens Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182480 | Earlens Contact Hearing Aid | PLK | 2019-01-25 | 137 |
| K153634 | Wireless Earlens Light Driven Hearing Aid | PLK | 2016-04-06 | 110 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150002 | De Novo | Tympanic Membrane Direct Contact Hearing Aid | 2015-09-29 |
Recalls
openFDA lists no recalls under a recalling firm named Earlens Corporation.
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.
Device clinical trials
Earlens Corporation is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02470494: The EarLens Contact Hearing Device (CHD) Spectrum Study (Completed, started 2015-06)
- NCT02042404: The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study (Completed, started 2014-03)
- NCT00582946: Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding (Completed, started 2006-05)
Frequently asked questions
How many FDA 510(k) clearances does Earlens Corporation have?
Earlens Corporation has 2 FDA 510(k) clearances (first 2016, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Earlens Corporation's 510(k)s?
The median time from FDA receipt to decision across Earlens Corporation's cleared 510(k)s is 124 days.
What devices does Earlens Corporation make?
Its most frequent FDA product codes are PLK (Tympanic Membrane Direct Contact Hearing Aid, 3).
Has Earlens Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Earlens Corporation. Related entities may recall under other names.
Next steps
- See all 2 Earlens Corporation clearances with predicates and recalls
- Run predicate analysis for product code PLK, Earlens Corporation'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.