Cleared Traditional

K872554 - HEARING AID 49 SERIES

K872554 is the FDA 510(k) clearance for HEARING AID 49 SERIES by Electone, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K872554 · Electone, Inc. · Ear, Nose, Throat device
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Jul 1987
Decision
17d
Days
Class 1
Risk

K872554 is an FDA 510(k) clearance for the HEARING AID 49 SERIES. 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 July 16, 1987 after a review of 17 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 K872554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1987
Decision Date July 16, 1987
Days to Decision 17 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
72d faster than avg
Panel avg: 89d · This submission: 17d
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 K872554.
POST-AURICULAR HEARING AID MODEL PE 805CD2
K872473 · Phonic Ear, Inc. · Jul 1987
POST-AURICULAR HEARING AID MODEL PE 805 SCD2
K872474 · Phonic Ear, Inc. · Jul 1987
HEARING AID S45 SERIES
K872553 · Electone, Inc. · Jul 1987
HEARING AID M35/M36 SERIES
K872556 · Electone, Inc. · Jul 1987
HEARING AID 47 SERIES
K872555 · Electone, Inc. · Jul 1987
BTE HEARING AID OTICON MODEL E30P
K872017 · Oticon Corp. · Jun 1987