Cleared Traditional

DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID (K852098) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K852098 · Miracle-Ear/Dahlberg, Inc. · Ear, Nose, Throat device
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Aug 1985
Decision
93d
Days
Class 1
Risk

K852098 is an FDA 510(k) clearance for the DAHLBERG MODEL US SPECTRUM IN-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 August 16, 1985 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Miracle-Ear/Dahlberg, Inc. devices

Submission Details

510(k) Number K852098 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 15, 1985
Decision Date August 16, 1985
Days to Decision 93 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
4d slower than avg
Panel avg: 89d · This submission: 93d
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.