Cleared Traditional

Nuance Audio Hearing Aid Software

K243150 · Luxottica Group S.P.A. · Ear, Nose, Throat
Jan 2025
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K243150 is an FDA 510(k) clearance for the Nuance Audio Hearing Aid Software, a Air-conduction Hearing Aid Software (Class II — Special Controls, product code SCR), submitted by Luxottica Group S.P.A. (Milan, IT). The FDA issued a Cleared decision on January 31, 2025, 123 days after receiving the submission on September 30, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3335.

Submission Details

510(k) Number K243150 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date January 31, 2025
Days to Decision 123 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code SCR — Air-conduction Hearing Aid Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3335
Definition Air-conduction Hearing Aid Software Is A Device That Is Intended To Be Used With A Compatible Wearable Hardware Platform To Compensate For Impaired Hearing. The Software Also Allows For Customization To The User's Hearing Needs. Devices In This Classification Are Also Subject To The Requirements In § 800.30 Or § 801.422 Of This Chapter, As Applicable. This Classification Does Not Include Software That Is Used With Hardware As Part Of A Hearing-aid Device System Classified In Other Regulations, E.g., § 874.3300, § 874.3305, Or § 874.3325.