Not Cleared Direct

Bose Hearing Aid (DEN180026) - FDA 510(k) Clearance

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

DEN180026 · Bose Corporation · Ear, Nose, Throat device
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Oct 2018
Decision
147d
Days
Class 2
Risk

DEN180026 is an FDA 510(k) submission (not cleared) for the Bose Hearing Aid. Classified as Self-fitting Air-conduction Hearing Aid, Prescription (product code QDD), Class II - Special Controls.

Submitted by Bose Corporation (Framingham, US). The FDA issued a Not Cleared (DENG) decision on October 5, 2018 after a review of 147 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3325 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Ear, Nose, Throat review framework.

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Submission Details

510(k) Number DEN180026 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 11, 2018
Decision Date October 05, 2018
Days to Decision 147 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
58d slower than avg
Panel avg: 89d · This submission: 147d
Pathway characteristics

Device Classification

Product Code QDD Self-fitting Air-conduction Hearing Aid, Prescription
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3325
Definition A Self-fitting Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device That Is Intended To Compensate For Impaired Hearing And Incorporates Technology, Including Software, That Allows Users To Program Their Hearing Aids. This Technology Integrates User Input With A Self-fitting Strategy And Enables Users To Independently Derive And Customize Their Hearing Aid Fitting And Settings. This Is A Prescription Hearing Aid.
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.