Cleared Special

K261142 - Ponto 5 Mini

Also marketed or referenced as:
Ponto 5 Superpower

K261142 is an FDA 510(k) clearance for Ponto 5 Mini, 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 141-day FDA review.

K261142 · Oticon Medical AB · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
141d
Days
Class 2
Risk

K261142 is an FDA 510(k) clearance for the Ponto 5 Mini. 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 August 26, 2026 after a review of 141 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. 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. Standard predicate reliance. 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 - K261142

510(k) Number K261142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2026
Decision Date August 26, 2026
Days to Decision 141 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
51d slower than avg
Panel avg: 90d · This submission: 141d
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 10
Devices cleared under the same product code (MAH) and FDA review panel - the closest regulatory comparables to K261142.
Ponto Bone Anchored Hearing System, MONO Surgery Kit
K203807 · Oticon Medical AB · Mar 2021
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