Cleared Traditional

K261187 - Hearing Aid Feature

K261187 is the FDA 510(k) clearance for Hearing Aid Feature by Samsung Electronics Co., Ltd.. It is a Class 2 Ear, Nose, Throat device (product code SCR) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K261187 · Samsung Electronics Co., Ltd. · Ear, Nose, Throat device
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Jul 2026
Decision
112d
Days
Class 2
Risk

K261187 is an FDA 510(k) clearance for the Hearing Aid Feature. Classified as Air-conduction Hearing Aid Software (product code SCR), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on July 31, 2026 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3335 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Samsung Electronics Co., Ltd. devices

Submission Details

510(k) Number K261187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2026
Decision Date July 31, 2026
Days to Decision 112 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 89d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code SCR Air-conduction Hearing Aid Software
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Samsung Research America, Inc.
Chaoyi Kang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.