Cleared Traditional

K150555 - BA400 14mm Abutment

K150555 is an FDA 510(k) clearance for BA400 14mm Abutment, manufactured by Cochlear Americas. The device is a Class 2 Ear, Nose, Throat device with product code MAH cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K150555 · Cochlear Americas · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Jul 2015
Decision
133d
Days
Class 2
Risk

K150555 is an FDA 510(k) clearance for the BA400 14mm Abutment. Classified as Hearing Aid, Bone Conduction, Implanted (product code MAH), Class II - Special Controls.

Submitted by Cochlear Americas (Centennial, US). The FDA issued a Cleared decision on July 15, 2015 after a review of 133 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 Cochlear Americas devices

FDA 510(k) Submission Details - K150555

510(k) Number K150555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2015
Decision Date July 15, 2015
Days to Decision 133 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 90d · This submission: 133d
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.

Regulatory Peers - MAH Hearing Aid, Bone Conduction, Implanted

All 10
Devices cleared under the same product code (MAH) and FDA review panel - the closest regulatory comparables to K150555.
BA310 Abutment, BIA310 Implant/Abutment
K182116 · Cochlear Americas · Dec 2018
Ponto Bone Anchored Hearing System
K152820 · Oticon Medical AB · Jan 2016
Ponto bone anchored hearing system
K152067 · Oticon Medical AB · Nov 2015
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
K142678 · Oticon Medical AB · Jan 2015
COCHLEAR BAHA IMPLANT SYSTEM
K121317 · Cochlear Americas · Oct 2012
PONTO BONE ANCHORED HEARING SYSTEM
K121228 · Oticon Medical AB · Sep 2012