Cleared Traditional

K881382 - XOMED AUDIANT BONE CONDUCTOR

K881382 is the FDA 510(k) clearance for XOMED AUDIANT BONE CONDUCTOR by Xomed, Inc.. It is a Class 2 Ear, Nose, Throat device (product code LXB) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K881382 · Xomed, Inc. · Ear, Nose, Throat device
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Jun 1988
Decision
81d
Days
Class 2
Risk

K881382 is an FDA 510(k) clearance for the XOMED AUDIANT BONE CONDUCTOR. 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 21, 1988 after a review of 81 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 K881382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1988
Decision Date June 21, 1988
Days to Decision 81 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
8d faster than avg
Panel avg: 89d · This submission: 81d
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 K881382.
NOBELPHARMA BONE ANCHORED HEARING AID
K955713 · Nobelpharma USA, Inc. · Aug 1996
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K935701 · Starkey Laboratories, Inc. · May 1994
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
K884056 · Xomed, Inc. · Nov 1988
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
K875277 · Xomed, Inc. · Mar 1988
XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.
K872168 · Xomed, Inc. · Jun 1987
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
K861971 · Xomed, Inc. · May 1986