Cleared Traditional

K131240 - COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT

K131240 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 LXB cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K131240 · Cochlear Americas · Ear, Nose, Throat device
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Nov 2013
Decision
190d
Days
Class 2
Risk

K131240 is an FDA 510(k) clearance for the COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT. 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 November 7, 2013 after a review of 190 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 - K131240

510(k) Number K131240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2013
Decision Date November 07, 2013
Days to Decision 190 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 90d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K131240.
Baha 5 Sound Processor
K142907 · Cochlear Americas · Mar 2015
PONTO PLUS AND PONTO PLUS POWER
K132775 · Oticon Medical AB · Dec 2013
OTOMAG BONE CONDUCATION HEARING SYSTEM
K132189 · Sophono, Inc. · Nov 2013
COCHLEAR BAHA 4 SOUND PROCESSOR
K132278 · Cochlear Americas · Sep 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