Cleared Traditional

K172460 - ADHEAR System

K172460 is an FDA 510(k) clearance for ADHEAR System, manufactured by Med-El Elektromedizinische Geraete GmbH. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K172460 · Med-El Elektromedizinische Geraete GmbH · Ear, Nose, Throat device
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Apr 2018
Decision
256d
Days
Class 2
Risk

K172460 is an FDA 510(k) clearance for the ADHEAR System. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Med-El Elektromedizinische Geraete GmbH (Innsbruck, AT). The FDA issued a Cleared decision on April 27, 2018 after a review of 256 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 Med-El Elektromedizinische Geraete GmbH devices

FDA 510(k) Submission Details - K172460

510(k) Number K172460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date April 27, 2018
Days to Decision 256 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
166d slower than avg
Panel avg: 90d · This submission: 256d
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 K172460.
Ponto 5 Mini
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Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
K202048 · Cochlear Americas · Feb 2021
Ponto 4
K190540 · Oticon Medical AB · May 2019
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