PLK
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tympanic Membrane Direct Contact Hearing Aid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3315
- Medical specialty
- Ear, Nose, Throat
- Flags
- Implant
- FDA definition
- A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Earlens Contact Hearing Aid (K182480) | Earlens Corporation | 2019-01-25 |
| Wireless Earlens Light Driven Hearing Aid (K153634) | Earlens Corporation | 2016-04-06 |
| EarLens Contact Hearing Device (DEN150002) | Earlens Corporation | 2015-09-29 |
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Every clearance here is in the API, with alerts when new ones post.