Cleared Traditional

K081606 - BAHA INTENSO

K081606 is an FDA 510(k) clearance for BAHA INTENSO, manufactured by Cochlear Americas. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K081606 · Cochlear Americas · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
83d
Days
Class 2
Risk

K081606 is an FDA 510(k) clearance for the BAHA INTENSO. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Cochlear Americas (Englewood, US). The FDA issued a Cleared decision on August 28, 2008 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K081606

510(k) Number K081606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2008
Decision Date August 28, 2008
Days to Decision 83 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
7d faster than avg
Panel avg: 90d · This submission: 83d
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 52
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K081606.
PONTO PRO
K090996 · Oticon Medical AB · Jul 2009
COCHLEAR BAHA BP100
K090720 · Cochlear Bone Anchored Systems AB · Jun 2009
OBC BONE ANCHORED HEARING AID SYSTEM
K082108 · Oticon Medical AB · Nov 2008
TRANSEAR BONE CONDUCTION HEARING AID
K062404 · Ear Technology Corp. · Sep 2006
TRANSEAR BONE CONDUCTION HEARING AID
K050653 · United Hearing Systems, Inc. · Jul 2005
BAHA DIVINO
K042017 · Entific Medical Systems, Inc. · Aug 2004
K081606 · BAHA INTENSO
Download PDF FDA Summary Cochlear Americas