Cleared Traditional

K955713 - NOBELPHARMA BONE ANCHORED HEARING AID

K955713 is an FDA 510(k) clearance for NOBELPHARMA BONE ANCHORED HEARING AID, manufactured by Nobelpharma USA, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K955713 · Nobelpharma USA, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
235d
Days
Class 2
Risk

K955713 is an FDA 510(k) clearance for the NOBELPHARMA BONE ANCHORED HEARING AID. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Westmont, US). The FDA issued a Cleared decision on August 9, 1996 after a review of 235 days - an extended review 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: 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 Nobelpharma USA, Inc. devices

FDA 510(k) Submission Details - K955713

510(k) Number K955713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date August 09, 1996
Days to Decision 235 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
145d slower than avg
Panel avg: 90d · This submission: 235d
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 44
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K955713.
TRANSEAR BONE CONDUCTION HEARING AID
K050653 · United Hearing Systems, Inc. · Jul 2005
BAHA DIVINO
K042017 · Entific Medical Systems, Inc. · Aug 2004
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
K992872 · Entific Medical Systems, Inc. · Nov 1999
SECOND EAR BONE CONDUCTION HEARING AID
K953872 · Wordcomp International Communication Group (Wicg) · Apr 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