FDA.reportPublic FDA data

De Novo DEN230081

Device
Hearing Aid Feature (HAF)
Contact
kevin go
De Novo number
DEN230081
Product code
SCR
Regulation
874.3335
Classification name
air-conduction hearing aid software
Decision
granted (DENG)
Decision date
2024-09-12
Date received
2023-12-04
Classification advisory
Ear Nose & Throat
Review advisory
Ear Nose & Throat
Type
Direct

Current FDA Classification#

Product code
SCR
Device name
Air-Conduction Hearing Aid Software
Medical specialty
Ear, Nose, Throat
Device class
2
Regulation
874.3335
Implant
N
Life sustain/support
N