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FDA 510(k)

Hearing Aid Feature

K-Number: K261187 · 2026-07-31

ApplicantSamsung Electronics Co., Ltd.
Decision Date2026-07-31
Product CodeSCR
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Hearing Aid Feature is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K261187. 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 Hearing Aid Feature?

Hearing Aid Feature is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K261187.

When did Hearing Aid Feature receive FDA 510(k) clearance?

Hearing Aid Feature received FDA 510(k) clearance on 2026-07-31, under 510(k) number K261187.

Who is the listed applicant for Hearing Aid Feature?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hearing Aid Feature?

The FDA product code for Hearing Aid Feature 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.

NCT07224919AutoFocus360 Sound Quality Preference and Claims StudyCOMPLETEDNCT07711249Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in BelgiumNOT_YET_RECRUITING

Other records listing Samsung Electronics Co., Ltd. as applicant

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.

K261011Sleep Apnea Feature (v2.0)K242651GM85K242478GF85 (models GF85-3P, GF85-SP)K240909Samsung ECG App v 1.3 (ECG)K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationK222353GM85

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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.

K254044Hearing assistMeta Platform Technologies, LLCK251208Tuned Self-Fitting Mobile AppTuned , Ltd.K243150Nuance Audio Hearing Aid SoftwareLuxottica Group S.P.A.

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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