Cleared Traditional

K872168 - XOMED AUDIANT BONE CONDUCTOR AT THE EAR...

K872168 is the FDA 510(k) clearance for XOMED AUDIANT BONE CONDUCTOR AT THE EAR... by Xomed, Inc.. It is a Class 2 Ear, Nose, Throat device (product code LXB) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K872168 · Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
22d
Days
Class 2
Risk

K872168 is an FDA 510(k) clearance for the XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 30, 1987 after a review of 22 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 Xomed, Inc. devices

Submission Details

510(k) Number K872168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date June 30, 1987
Days to Decision 22 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 89d · This submission: 22d
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 15
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K872168.
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
K884056 · Xomed, Inc. · Nov 1988
XOMED AUDIANT BONE CONDUCTOR
K881382 · Xomed, Inc. · Jun 1988
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
K875277 · Xomed, Inc. · Mar 1988
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
K861971 · Xomed, Inc. · May 1986
AUDIANT BONE CONDUCTOR OR A.B.C.
K855059 · Xomed, Inc. · Apr 1986