Not Cleared Direct

DEN230081 - Hearing Aid Feature (HAF) (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230081 · Apple, Inc. · Ear, Nose, Throat device
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Sep 2024
Decision
283d
Days
Class 2
Risk

DEN230081 is an FDA 510(k) submission (not cleared) for the Hearing Aid Feature (HAF). Classified as Air-conduction Hearing Aid Software (product code SCR), Class II - Special Controls.

Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Not Cleared (DENG) decision on September 12, 2024 after a review of 283 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 283 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN230081 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 04, 2023
Decision Date September 12, 2024
Days to Decision 283 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 89d · This submission: 283d
Pathway characteristics

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.