Cleared Special

K132278 - COCHLEAR BAHA 4 SOUND PROCESSOR

K132278 is an FDA 510(k) clearance for COCHLEAR BAHA 4 SOUND PROCESSOR, manufactured by Cochlear Americas. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Special 510(k) pathway after a 65-day FDA review.

K132278 · Cochlear Americas · Ear, Nose, Throat device
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Sep 2013
Decision
65d
Days
Class 2
Risk

K132278 is an FDA 510(k) clearance for the COCHLEAR BAHA 4 SOUND PROCESSOR. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Cochlear Americas (Centennial, US). The FDA issued a Cleared decision on September 26, 2013 after a review of 65 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cochlear Americas devices

FDA 510(k) Submission Details - K132278

510(k) Number K132278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2013
Decision Date September 26, 2013
Days to Decision 65 days
Submission Type Special
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
25d faster than avg
Panel avg: 90d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

LXB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LXB Hearing Aid, Bone Conduction

All 43
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K132278.
PONTO PLUS AND PONTO PLUS POWER
K132775 · Oticon Medical AB · Dec 2013
OTOMAG BONE CONDUCATION HEARING SYSTEM
K132189 · Sophono, Inc. · Nov 2013
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
K131240 · Cochlear Americas · Nov 2013
OTOMAG BONE CONDUCTION HEARING SYSTEM
K123962 · Sophono, Inc. · Apr 2013
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
K121793 · Audifon-USA, Inc. · Nov 2012
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
K110831 · Sonitus Medical, Inc. · Jun 2011