Clearance Summary
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App received FDA 510(k) clearance under submission number K212136, sponsored by Cochlear Americas. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2021-09-29.
- Submission: K212136
- Applicant / Sponsor: Cochlear Americas
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3302
- Decision date: 2021-09-29
Classification & Regulation
This clearance is catalogued under FDA product code LXB and 21 CFR 874.3302, within the Ear, Nose, Throat review panel as a Class II device.