Cleared Special

K161123 - Baha 5 Power Sound Processor

K161123 is an FDA 510(k) clearance for Baha 5 Power 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 29-day FDA review.

K161123 · Cochlear Americas · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
29d
Days
Class 2
Risk

K161123 is an FDA 510(k) clearance for the Baha 5 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 May 20, 2016 after a review of 29 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 - K161123

510(k) Number K161123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2016
Decision Date May 20, 2016
Days to Decision 29 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
61d faster than avg
Panel avg: 90d · This submission: 29d
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 K161123.
Cochlear Baha SoundArc
K171088 · Cochlear Americas · Jun 2017
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 Super Power Sound Processor
K153245 · Cochlear Americas · Mar 2016
Cordelle II Sound Processor
K150751 · Cochlear Americas · Jul 2015
Baha 5 Sound Processor
K142907 · Cochlear Americas · Mar 2015