Cleared Traditional

K965057 - AUDIOTONE (A554H)

K965057 is an FDA 510(k) clearance for AUDIOTONE (A554H), manufactured by Miracle-Ear, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K965057 · Miracle-Ear, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
40d
Days
Class 1
Risk

K965057 is an FDA 510(k) clearance for the AUDIOTONE (A554H). Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Miracle-Ear, Inc. (Golden Valley, US). The FDA issued a Cleared decision on January 27, 1997 after a review of 40 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

FDA 510(k) Submission Details - K965057

510(k) Number K965057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date January 27, 1997
Days to Decision 40 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 90d · This submission: 40d
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 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K965057.
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
K964245 · Starkey Laboratories, Inc. · Feb 1997
MIRACLE - EAR (ITE/ITC/CIC)
K964419 · Miracle-Ear, Inc. · Feb 1997
DAHLBERG (A-554)
K965049 · Miracle-Ear, Inc. · Jan 1997
AUDIOTONE (A-552)
K965063 · Miracle-Ear, Inc. · Jan 1997
COMFORTAID HEARING AID
K964680 · Ethical Hearing Instruments · Jan 1997
M11 SERIES: M11, M11M
K965088 · Philips Hearing Instruments Co. · Jan 1997