Cleared Traditional

K153245 - Baha 5 Super Power Sound Processor

K153245 is an FDA 510(k) clearance for Baha 5 Super Power Sound Processor, 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 114-day FDA review.

K153245 · Cochlear Americas · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Mar 2016
Decision
114d
Days
Class 2
Risk

K153245 is an FDA 510(k) clearance for the Baha 5 Super Power 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 March 2, 2016 after a review of 114 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 - K153245

510(k) Number K153245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date March 02, 2016
Days to Decision 114 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
24d slower than avg
Panel avg: 90d · This submission: 114d
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 K153245.
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
K161671 · Oticon Medical AB · Sep 2016
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
K153391 · Sophono, Inc. · Jun 2016
Baha 5 Power Sound Processor
K161123 · Cochlear Americas · May 2016
Cordelle II Sound Processor
K150751 · Cochlear Americas · Jul 2015
Baha 5 Sound Processor
K142907 · Cochlear Americas · Mar 2015
PONTO PLUS AND PONTO PLUS POWER
K132775 · Oticon Medical AB · Dec 2013