510(k) DEN150002
DEN150002 is an FDA 510(k) premarket notification submitted by Earlens Corporation for the device "EarLens Contact Hearing Device". The FDA issued a decision of De Novo granted on Sep 29, 2015. The device falls under product code PLK (Tympanic Membrane Direct Contact Hearing Aid), a Class II device regulated under 21 CFR 874.3315. Earlens Corporation has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Sep 29, 2015
- Date Received
- Jan 2, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tympanic Membrane Direct Contact Hearing Aid
- Device Class
- Class II
- Regulation Number
- 874.3315
- Review Panel
- EN
- Submission Type
- 510(k)
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.