Cleared Traditional

K901745 - AUDIOTONE MODEL A-52S BEHIND-THE-EAR HE...

K901745 is the FDA 510(k) clearance for AUDIOTONE MODEL A-52S BEHIND-THE-EAR HE... by Miracle-Ear, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K901745 · Miracle-Ear, Inc. · Ear, Nose, Throat device
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May 1990
Decision
42d
Days
Class 1
Risk

K901745 is an FDA 510(k) clearance for the AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Miracle-Ear, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 29, 1990 after a review of 42 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, Inc. devices

Submission Details

510(k) Number K901745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1990
Decision Date May 29, 1990
Days to Decision 42 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
47d faster than avg
Panel avg: 89d · This submission: 42d
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 K901745.
CUSTOM ITE HEARING AID MODELS C AND M
K902351 · Oticon Corp. · Jun 1990
CUSTOM ITE HEARING AID MODEL: H
K902352 · Oticon Corp. · Jun 1990
CUSTOM ITE HEARING AID MODELS F AND L
K902353 · Oticon Corp. · Jun 1990
AUDIOTONE ITE HEARING AID MODEL ZD (XT)
K901746 · Miracle-Ear, Inc. · May 1990
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
K901747 · Miracle-Ear, Inc. · May 1990
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
K901783 · Miracle-Ear, Inc. · May 1990