Cleared Traditional

K870503 - HEARING AID

K870503 is the FDA 510(k) clearance for HEARING AID by Unitron Industries, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K870503 · Unitron Industries, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
35d
Days
Class 1
Risk

K870503 is an FDA 510(k) clearance for the HEARING AID, UNITRON MODEL UM60. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Unitron Industries, Inc. (Port Huron, US). The FDA issued a Cleared decision on March 11, 1987 after a review of 35 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 Unitron Industries, Inc. devices

Submission Details

510(k) Number K870503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1987
Decision Date March 11, 1987
Days to Decision 35 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
54d faster than avg
Panel avg: 89d · This submission: 35d
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 K870503.
DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID
K870691 · Dahlberg Electronics, Inc. · Mar 1987
MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS
K870434 · Telex Communications, Inc. · Mar 1987
MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID
K870435 · Telex Communications, Inc. · Mar 1987
PHONIC EAR MODELS PE 811CS AND PE 811CST
K864672 · Phonic Ear, Inc. · Feb 1987
WIDEX HEARING AID MODEL ES2
K864097 · Widex Hearing Aid Co., Inc. · Nov 1986
UNITRON MODEL UL21 HEARING AID
K863225 · Unitron Industries, Inc. · Oct 1986