| Primary Device ID | 08500130070130 |
| NIH Device Record Key | 548df2d4-116e-46db-a62f-497a4ab0d01a |
| Commercial Distribution Discontinuation | 2020-01-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Earlens Light Driven Hearing Aid, Monaural, Left |
| Version Model Number | MKEL1L |
| Catalog Number | MKEL1L |
| Company DUNS | 611658795 |
| Company Name | EARLENS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08500130070130 [Primary] |
| PLK | Tympanic Membrane Direct Contact Hearing Aid |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 8 |
| Public Version Date | 2020-01-31 |
| Device Publish Date | 2016-09-24 |
| 08500130070192 - Earlens ELF USB | 2023-11-03 Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot n |
| 00850013007387 - Impression Dispenser | 2023-06-19 |
| 00850013007516 - Earlens Processor, Champagne | 2023-06-19 |
| 00850013007523 - Earlens Processor, Silver | 2023-06-19 |
| 00850013007530 - Earlens Processor, Black | 2023-06-19 |
| 00850013007547 - Earlens Ear Tip, Left | 2023-06-19 |
| 00850013007554 - Earlens Ear Tip, Right | 2023-06-19 |
| 00850013007561 - Earlens Tympanic Lens, Left | 2023-06-19 |