Cleared Traditional

K142678 - Ponto Bone Anchored Hearing system/ Abu...

K142678 is an FDA 510(k) clearance for Ponto Bone Anchored Hearing system/ Abu..., 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 124-day FDA review.

K142678 · Oticon Medical AB · Ear, Nose, Throat device
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Jan 2015
Decision
124d
Days
Class 2
Risk

K142678 is an FDA 510(k) clearance for the Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Heari.... 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 January 21, 2015 after a review of 124 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.

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FDA 510(k) Submission Details - K142678

510(k) Number K142678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2014
Decision Date January 21, 2015
Days to Decision 124 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
35d slower than avg
Panel avg: 89d · This submission: 124d
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.