Cleared Special

K203807 - Ponto Bone Anchored Hearing System, MONO Surgery Kit (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K203807 · Oticon Medical AB · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
24d faster than avg
Panel avg: 89d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.