The following data is part of a De Novo classification by Earlens Corporation with the FDA for Earlens Contact Hearing Device.
| DeNovo ID | DEN150002 |
| Device Name: | EarLens Contact Hearing Device |
| Classification | Tympanic Membrane Direct Contact Hearing Aid |
| Applicant | EARLENS CORPORATION 4045-a Cambbell Avenue Menlo Park, CA 94025 |
| Contact | Suzanne Levy |
| Product Code | PLK |
| CFR Regulation Number | 874.3315 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Ear Nose & Throat |
| Classification Advisory | Ear Nose & Throat |
| Type | Direct |
| Date Received | 2015-01-02 |
| Decision Date | 2015-09-29 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |