Clearance Summary
Nuance Audio Hearing Aid Software received FDA 510(k) clearance under submission number K243150, sponsored by Luxottica Group S.P.A.. 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 2025-01-31.
- Submission: K243150
- Applicant / Sponsor: Luxottica Group S.P.A.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3335
- Decision date: 2025-01-31
Classification & Regulation
This clearance is catalogued under FDA product code SCR and 21 CFR 874.3335, within the Ear, Nose, Throat review panel as a Class II device.