Clearance Summary
Bose SoundControl Hearing Aids received FDA 510(k) clearance under submission number K211008, sponsored by Bose Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2021-05-05.
- Submission: K211008
- Applicant / Sponsor: Bose Corporation
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3325
- Decision date: 2021-05-05
Classification & Regulation
This clearance is catalogued under FDA product code QDD and 21 CFR 874.3325, within the Ear, Nose, Throat review panel as a Class II device.