Cleared Traditional

K121317 - COCHLEAR BAHA IMPLANT SYSTEM

K121317 is an FDA 510(k) clearance for COCHLEAR BAHA IMPLANT SYSTEM, 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 163-day FDA review.

K121317 · Cochlear Americas · Ear, Nose, Throat device
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Oct 2012
Decision
163d
Days
Class 2
Risk

K121317 is an FDA 510(k) clearance for the COCHLEAR BAHA IMPLANT SYSTEM. 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 October 12, 2012 after a review of 163 days - an extended review 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: 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 - K121317

510(k) Number K121317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2012
Decision Date October 12, 2012
Days to Decision 163 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
73d slower than avg
Panel avg: 90d · This submission: 163d
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 K121317.
Ponto bone anchored hearing system
K152067 · Oticon Medical AB · Nov 2015
BA400 14mm Abutment
K150555 · Cochlear Americas · Jul 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
PONTO BONE ANCHORED HEARING SYSTEM
K121228 · Oticon Medical AB · Sep 2012
OBC BONE ANCHORED HEARING SYSTEM
K112053 · Oticon Medical AB · Nov 2011
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE
K984162 · Nobelpharma USA, Inc. · Jun 1999