510(k) DEN180026
DEN180026 is an FDA 510(k) premarket notification submitted by Bose Corporation for the device "Bose Hearing Aid". The FDA issued a decision of De Novo Granted on October 5, 2018. The device falls under product code QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription), a Class II device regulated under 21 CFR 874.3325. Bose Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 5, 2018
- Date Received
- May 11, 2018
- Clearance Type
- Direct
- 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.