Cleared Traditional

K840893 - CONFERETTE C2

K840893 is the FDA 510(k) clearance for CONFERETTE C2 by Siemens Hearing Instruments, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K840893 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
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Aug 1984
Decision
157d
Days
Class 1
Risk

K840893 is an FDA 510(k) clearance for the CONFERETTE C2. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Siemens Hearing Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 157 days - an extended review cycle.

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 Siemens Hearing Instruments, Inc. devices

Submission Details

510(k) Number K840893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date August 02, 1984
Days to Decision 157 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
68d slower than avg
Panel avg: 89d · This submission: 157d
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 660
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K840893.
EARETTE HEARING AID OTICON E31V
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EARETTE HEARING AID OTICON E30V
K842074 · Oticon Corp. · Aug 1984
RIONET HEARING AID HI-03
K841935 · Rion Acoustic Instruments, Inc. · Aug 1984
OTICON E28A
K841436 · Oticon Corp. · Jun 1984
MCA IN THE EAR CUSTOM HEARING AID
K840298 · Maico Hearing Instruments, Inc. · Apr 1984
CANAL AID
K840165 · Qualitone · Apr 1984