FDA.reportPublic FDA data

De Novo DEN150002

Device
EarLens Contact Hearing Device
Contact
suzanne levy
De Novo number
DEN150002
Product code
PLK
Regulation
874.3315
Classification name
tympanic membrane direct contact hearing aid
Decision
granted (DENG)
Decision date
2015-09-29
Date received
2015-01-02
Classification advisory
Ear Nose & Throat
Review advisory
Ear Nose & Throat
Type
Direct

Current FDA Classification#

Product code
PLK
Device name
Tympanic Membrane Direct Contact Hearing Aid
Medical specialty
Ear, Nose, Throat
Device class
2
Regulation
874.3315
Implant
Y
Life sustain/support
N