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FDA 510(k)

Nuance Audio Hearing Aid Software

K-Number: K243150 · 2025-01-31

ApplicantLuxottica Group S.P.A.
Decision Date2025-01-31
Product CodeSCR
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Nuance Audio Hearing Aid Software is the device name listed in this FDA 510(k) record. The listed applicant is Luxottica Group S.P.A.. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K243150. The device is classified under product code SCR. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nuance Audio Hearing Aid Software?

Nuance Audio Hearing Aid Software is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Luxottica Group S.P.A.. The 510(k) number is K243150.

When did Nuance Audio Hearing Aid Software receive FDA 510(k) clearance?

Nuance Audio Hearing Aid Software received FDA 510(k) clearance on 2025-01-31, under 510(k) number K243150.

Who is the listed applicant for Nuance Audio Hearing Aid Software?

The FDA 510(k) record lists Luxottica Group S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nuance Audio Hearing Aid Software?

The FDA product code for Nuance Audio Hearing Aid Software is SCR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07572357Clinical Evaluation of the RH210 Hearing AidRECRUITING

Related Devices (Code: SCR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261187Hearing Aid FeatureSamsung Electronics Co., Ltd.K254044Hearing assistMeta Platform Technologies, LLCK251208Tuned Self-Fitting Mobile AppTuned , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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