Cleared Traditional

K860190 - A & M DISCREET - HEARING AID

K860190 is the FDA 510(k) clearance for A & M DISCREET - HEARING AID by Electone, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K860190 · Electone, Inc. · Ear, Nose, Throat device
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Mar 1986
Decision
49d
Days
Class 1
Risk

K860190 is an FDA 510(k) clearance for the A & M DISCREET - HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Electone, Inc. (Winter Park, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electone, Inc. devices

Submission Details

510(k) Number K860190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date March 12, 1986
Days to Decision 49 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
40d faster than avg
Panel avg: 89d · This submission: 49d
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 K860190.
MODEL 353C HEARING AID
K860035 · Telex Communications, Inc. · Mar 1986
AM 12, HEARING AID
K860007 · Electone, Inc. · Mar 1986
AM 31, HEARING AID
K860008 · Electone, Inc. · Mar 1986
PA PRESIDENTIAL II - HEARING AID
K860191 · Electone, Inc. · Mar 1986
A & M 150 PP (HEARING AID)
K860244 · Electone, Inc. · Mar 1986
THE ANSWER HEARING AID
K854438 · Electone, Inc. · Feb 1986