Cleared Special

K061459 - TRANQUIL TRI-BTE

K061459 is an FDA 510(k) clearance for TRANQUIL TRI-BTE, manufactured by General Hearing Instruments, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Special 510(k) pathway after a 35-day FDA review.

K061459 · General Hearing Instruments, Inc. · Ear, Nose, Throat device
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Jun 2006
Decision
35d
Days
Class 2
Risk

K061459 is an FDA 510(k) clearance for the TRANQUIL TRI-BTE. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by General Hearing Instruments, Inc. (New Orleans, US). The FDA issued a Cleared decision on June 30, 2006 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all General Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K061459

510(k) Number K061459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2006
Decision Date June 30, 2006
Days to Decision 35 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 90d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

KLW Device Classification - Class 2, Special Controls

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
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 - KLW Masker, Tinnitus

All 58
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K061459.
TINNITUS SOUND GENERATOR MODULE
K073636 · Gn Resound A/S · Mar 2008
CUSTOMIZED SOUND THERAPY (CST)
K070599 · Tinnitus Otosound Products, LLC · Jul 2007
THE INHIBITOR, MODEL 001
K070648 · Melmedtronics, Inc. · Jun 2007
TINNITUS PHASE-OUT
K061111 · Tinnitus Control, Inc. · May 2006
NEUROMONICS TINNITUS TREATMENT
K043274 · Neuromonics Pty, Ltd. · Jan 2005
REFUGE SOUND GENERATOR
K041302 · Micro-Ear Technology, Inc. · Jul 2004