Cleared Traditional

BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) (K021837) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021837 · Entific Medical Systems, Inc. · Ear, Nose, Throat device
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Aug 2002
Decision
87d
Days
Class 2
Risk

K021837 is an FDA 510(k) clearance for the BRANENMARK BONE-ANCHORED-HEARING AID (BAHA). Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Entific Medical Systems, Inc. (Findley, US). The FDA issued a Cleared decision on August 30, 2002 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3302 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Entific Medical Systems, Inc. devices

Submission Details

510(k) Number K021837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2002
Decision Date August 30, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 89d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXB Hearing Aid, Bone Conduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3302
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.