Cleared Traditional

K050653 - TRANSEAR BONE CONDUCTION HEARING AID

K050653 is an FDA 510(k) clearance for TRANSEAR BONE CONDUCTION HEARING AID, manufactured by United Hearing Systems, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K050653 · United Hearing Systems, Inc. · Ear, Nose, Throat device
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Jul 2005
Decision
112d
Days
Class 2
Risk

K050653 is an FDA 510(k) clearance for the TRANSEAR BONE CONDUCTION HEARING AID. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by United Hearing Systems, Inc. (Central Village, US). The FDA issued a Cleared decision on July 1, 2005 after a review of 112 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 United Hearing Systems, Inc. devices

FDA 510(k) Submission Details - K050653

510(k) Number K050653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2005
Decision Date July 01, 2005
Days to Decision 112 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 90d · This submission: 112d
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.

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 K050653.
OBC BONE ANCHORED HEARING AID SYSTEM
K082108 · Oticon Medical AB · Nov 2008
BAHA INTENSO
K081606 · Cochlear Americas · Aug 2008
TRANSEAR BONE CONDUCTION HEARING AID
K062404 · Ear Technology Corp. · Sep 2006
BAHA DIVINO
K042017 · Entific Medical Systems, Inc. · Aug 2004
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
K992872 · Entific Medical Systems, Inc. · Nov 1999
NOBELPHARMA BONE ANCHORED HEARING AID
K955713 · Nobelpharma USA, Inc. · Aug 1996