Cleared Traditional

K161671 - Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161671 · Oticon Medical AB · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
105d
Days
Class 2
Risk

K161671 is an FDA 510(k) clearance for the Ponto 3, Ponto 3 Power and Ponto 3 SuperPower. 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 September 29, 2016 after a review of 105 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

Submission Details

510(k) Number K161671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2016
Decision Date September 29, 2016
Days to Decision 105 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 89d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K161671.
Baha 7 Sound Processor
K250215 · Cochlear · May 2025
contact forte Alpha
K243041 · Bhm-Tech Produktionsgesellschaft Mbh · Apr 2025
Ponto 5 SuperPower
K213733 · Oticon Medical AB · Dec 2021
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
K212136 · Cochlear Americas · Sep 2021
Ponto 5 Mini
K211640 · Oticon Medical AB · Aug 2021
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
K202048 · Cochlear Americas · Feb 2021