Cleared Traditional

K132775 - PONTO PLUS AND PONTO PLUS POWER

K132775 is an FDA 510(k) clearance for PONTO PLUS AND PONTO PLUS POWER, manufactured by Oticon Medical AB. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K132775 · Oticon Medical AB · Ear, Nose, Throat device
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Dec 2013
Decision
95d
Days
Class 2
Risk

K132775 is an FDA 510(k) clearance for the PONTO PLUS AND PONTO PLUS POWER. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on December 9, 2013 after a review of 95 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 Oticon Medical AB devices

FDA 510(k) Submission Details - K132775

510(k) Number K132775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2013
Decision Date December 09, 2013
Days to Decision 95 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
5d slower than avg
Panel avg: 90d · This submission: 95d
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 51
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K132775.
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
OTOMAG BONE CONDUCATION HEARING SYSTEM
K132189 · Sophono, Inc. · Nov 2013
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
K131240 · Cochlear Americas · Nov 2013
COCHLEAR BAHA 4 SOUND PROCESSOR
K132278 · Cochlear Americas · Sep 2013