Earlens Contact Hearing Aid
FDA 510(k) clearance K182480 · decided 2019-01-25
Clearance details
- K-number
- K182480
- Device name
- Earlens Contact Hearing Aid
- Applicant
- Earlens Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-09-10
- Decision date
- 2019-01-25
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- PLK
- Device class
- 2
- Regulation number
- 874.3315
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Earlens Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Wireless Earlens Light Driven Hearing Aid (K153634) | Earlens Corporation | 2016-04-06 |
| EarLens Contact Hearing Device (DEN150002) | Earlens Corporation | 2015-09-29 |
Recalls involving this device
No recalls on record reference this clearance.