Cleared Traditional

K112053 - OBC BONE ANCHORED HEARING SYSTEM

K112053 is an FDA 510(k) clearance for OBC BONE ANCHORED HEARING SYSTEM, manufactured by Oticon Medical AB. The device is a Class 2 Ear, Nose, Throat device with product code MAH cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K112053 · Oticon Medical AB · Ear, Nose, Throat device
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Nov 2011
Decision
122d
Days
Class 2
Risk

K112053 is an FDA 510(k) clearance for the OBC BONE ANCHORED HEARING SYSTEM. Classified as Hearing Aid, Bone Conduction, Implanted (product code MAH), Class II - Special Controls.

Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on November 18, 2011 after a review of 122 days - within the typical 510(k) review window.

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: 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 Oticon Medical AB devices

FDA 510(k) Submission Details - K112053

510(k) Number K112053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2011
Decision Date November 18, 2011
Days to Decision 122 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 89d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAH Device Classification - Class 2, Special Controls

Product Code MAH Hearing Aid, Bone Conduction, Implanted
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.