Cleared Traditional

BAHA INTENSO (K081606) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081606 · Cochlear Americas · Ear, Nose, Throat device
Download Printable Device Report (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.

View all Cochlear Americas devices

Submission Details

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
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 89d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K081606.
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