Cleared Traditional

K851869 - DAHLBERG MODEL DC BEHIND-THE-EAR HEARIN...

K851869 is an FDA 510(k) clearance for DAHLBERG MODEL DC BEHIND-THE-EAR HEARIN..., manufactured by Miracle-Ear/Dahlberg, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K851869 · Miracle-Ear/Dahlberg, Inc. · Ear, Nose, Throat device
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Jul 1985
Decision
67d
Days
Class 1
Risk

K851869 is an FDA 510(k) clearance for the DAHLBERG MODEL DC BEHIND-THE-EAR HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Miracle-Ear/Dahlberg, Inc. (Golden Valley, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 67 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 Miracle-Ear/Dahlberg, Inc. devices

FDA 510(k) Submission Details - K851869

510(k) Number K851869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1985
Decision Date July 05, 1985
Days to Decision 67 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 89d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K851869.
RIONET HEARING AID HB-34HT
K852451 · Rion Acoustic Instruments, Inc. · Aug 1985
RIONET HEARING AID HB-71P
K852452 · Rion Acoustic Instruments, Inc. · Aug 1985
HEARING AID, UNITRON MODEL UM60-H
K852690 · Unitron Industries, Inc. · Jul 1985
CRESTLINE CL IN-THE-EAR HEARING AID
K850980 · Dahlberg Electronics, Inc. · Jun 1985
HEARING AID, UNITRON MODEL UC
K850914 · Unitron Industries, Inc. · Jun 1985
QUALITONE STOCK CANAL AID
K851970 · Qualitone · Jun 1985