Cleared Traditional

K855059 - AUDIANT BONE CONDUCTOR OR A.B.C.

K855059 is an FDA 510(k) clearance for AUDIANT BONE CONDUCTOR OR A.B.C., manufactured by Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K855059 · Xomed, Inc. · Ear, Nose, Throat device
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Apr 1986
Decision
106d
Days
Class 2
Risk

K855059 is an FDA 510(k) clearance for the AUDIANT BONE CONDUCTOR OR A.B.C.. 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 April 3, 1986 after a review of 106 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Xomed, Inc. devices

FDA 510(k) Submission Details - K855059

510(k) Number K855059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1985
Decision Date April 03, 1986
Days to Decision 106 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
16d slower than avg
Panel avg: 90d · This submission: 106d
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.