Cleared Special

K203807 - Ponto Bone Anchored Hearing System, MONO Surgery Kit

K203807 is an FDA 510(k) clearance for Ponto Bone Anchored Hearing System, manufactured by Oticon Medical AB. The device is a Class 2 Ear, Nose, Throat device with product code MAH cleared through the Special 510(k) pathway after a 65-day FDA review.

K203807 · Oticon Medical AB · Ear, Nose, Throat device
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Mar 2021
Decision
65d
Days
Class 2
Risk

K203807 is an FDA 510(k) clearance for the Ponto Bone Anchored Hearing System, MONO Surgery Kit. Classified as Hearing Aid, Bone Conduction, Implanted (product code MAH), Class II - Special Controls.

Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on March 3, 2021 after a review of 65 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 Oticon Medical AB devices

FDA 510(k) Submission Details - K203807

510(k) Number K203807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2020
Decision Date March 03, 2021
Days to Decision 65 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
25d faster than avg
Panel avg: 90d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

MAH Device Classification - Class 2, Special Controls

Product Code MAH Hearing Aid, Bone Conduction, Implanted
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 - MAH Hearing Aid, Bone Conduction, Implanted

All 11
Devices cleared under the same product code (MAH) and FDA review panel - the closest regulatory comparables to K203807.
Ponto 5 Mini
K261142 · Oticon Medical AB · Aug 2026
BA310 Abutment, BIA310 Implant/Abutment
K182116 · Cochlear Americas · Dec 2018
Ponto Bone Anchored Hearing System
K152820 · Oticon Medical AB · Jan 2016
Ponto bone anchored hearing system
K152067 · Oticon Medical AB · Nov 2015
BA400 14mm Abutment
K150555 · Cochlear Americas · Jul 2015
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
K142678 · Oticon Medical AB · Jan 2015