Cleared Traditional

K951642 - GOLD CD ULTRA MINI CANAL - MODULE

K951642 is the FDA 510(k) clearance for GOLD CD ULTRA MINI CANAL - MODULE by Electone, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K951642 · Electone, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
92d
Days
Class 1
Risk

K951642 is an FDA 510(k) clearance for the GOLD CD ULTRA MINI CANAL - MODULE. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Electone, Inc. (Longwood, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 Electone, Inc. devices

Submission Details

510(k) Number K951642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date July 11, 1995
Days to Decision 92 days
Submission Type Traditional
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
3d slower than avg
Panel avg: 89d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K951642.
AM 260 OHM
K953054 · Electone, Inc. · Aug 1995
PERSONAL PROGRAMMER 2000
K952940 · Siemens Hearing Instruments, Inc. · Jul 1995
RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION
K953266 · Resound Corp. · Jul 1995
BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K
K951587 · Beltone Electronics Corp. · Jun 1995
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
K951828 · Siemens Hearing Instruments, Inc. · Jun 1995
BELTONE COMPOSER 2000
K950868 · Beltone Electronics Corp. · Jun 1995