510(k) K220403
K220403 is an FDA 510(k) premarket notification submitted by Wsaud A/S for the device "Vibe SF Self-Fitting Hearing Aid". The FDA issued a decision of Substantially Equivalent on August 12, 2022. The device falls under product code QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription), a Class II device regulated under 21 CFR 874.3325. Wsaud A/S has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2022
- Date Received
- February 11, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Self-Fitting Air-Conduction Hearing Aid, Prescription
- Device Class
- Class II
- Regulation Number
- 874.3325
- Review Panel
- EN
- Submission Type
A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid.