510(k) K153634
K153634 is an FDA 510(k) premarket notification submitted by Earlens Corporation for the device "Wireless Earlens Light Driven Hearing Aid". The FDA issued a decision of Substantially Equivalent on April 6, 2016. 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 at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2016
- Date Received
- December 18, 2015
- Clearance Type
- Traditional
- 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
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.