Cleared Traditional

K884056 - MODIFIED IMPLANT FOR XOMED AUDIANT BONE...

K884056 is the FDA 510(k) clearance for MODIFIED IMPLANT FOR XOMED AUDIANT BONE... by Xomed, Inc.. It is a Class 2 Ear, Nose, Throat device (product code LXB) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K884056 · Xomed, Inc. · Ear, Nose, Throat device
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Nov 1988
Decision
65d
Days
Class 2
Risk

K884056 is an FDA 510(k) clearance for the MODIFIED IMPLANT FOR 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 November 30, 1988 after a review of 65 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 K884056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1988
Decision Date November 30, 1988
Days to Decision 65 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
24d faster than avg
Panel avg: 89d · This submission: 65d
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 K884056.
ADHEAR System
K172460 · Med-El Elektromedizinische Geraete GmbH · Apr 2018
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
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 AT THE EAR SOUND PRO.
K872168 · Xomed, Inc. · Jun 1987