Cleared Traditional

K874380 - BTE HEARING AID OTICON MODEL E38P

K874380 is the FDA 510(k) clearance for BTE HEARING AID OTICON MODEL E38P by Oticon Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K874380 · Oticon Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
64d
Days
Class 1
Risk

K874380 is an FDA 510(k) clearance for the BTE HEARING AID OTICON MODEL E38P. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Oticon Corp. (Somerset, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 64 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 Oticon Corp. devices

Submission Details

510(k) Number K874380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1987
Decision Date December 29, 1987
Days to Decision 64 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
25d faster than avg
Panel avg: 89d · This submission: 64d
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 K874380.
AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID
K874831 · Dahlberg Electronics, Inc. · Feb 1988
MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID
K874830 · Dahlberg Electronics, Inc. · Feb 1988
OTICON HEARING AID MODEL I52
K874651 · Oticon Corp. · Jan 1988
BTE HEARING AID OTICON MODEL E39PL
K874381 · Oticon Corp. · Dec 1987
POST AURICULAR HEARING AID 46PP-PC SUMMIT
K874707 · Richards Medical Co., Inc. · Dec 1987
OTICON MODEL I50 IN-THE-EAR HEARING AID
K874744 · Oticon Corp. · Dec 1987