510(k) K243150
K243150 is an FDA 510(k) premarket notification submitted by Luxottica Group S.P.A. for the device "Nuance Audio Hearing Aid Software". The FDA issued a decision of Substantially Equivalent on January 31, 2025. The device falls under product code SCR (Air-Conduction Hearing Aid Software), a Class II device regulated under 21 CFR 874.3335.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2025
- Date Received
- September 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Air-Conduction Hearing Aid Software
- Device Class
- Class II
- Regulation Number
- 874.3335
- Review Panel
- EN
- Submission Type
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.