The following data is part of a premarket notification filed by Earlens Corporation with the FDA for Wireless Earlens Light Driven Hearing Aid.
| Device ID | K153634 |
| 510k Number | K153634 |
| Device Name: | Wireless Earlens Light Driven Hearing Aid |
| Classification | Tympanic Membrane Direct Contact Hearing Aid |
| Applicant | EARLENS CORPORATION 4045-A CAMPBELL AVENUE Menlo Park, CA 94025 |
| Contact | Deborah Arthur |
| Correspondent | Deborah Arthur EARLENS CORPORATION 4045-A CAMPBELL AVENUE Menlo Park, CA 94025 |
| Product Code | PLK |
| CFR Regulation Number | 874.3315 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-18 |
| Decision Date | 2016-04-06 |