Cleared Traditional

K972552 - AUDIFON H20 PC/AUDIFON H32 PP

K972552 is an FDA 510(k) clearance for AUDIFON H20 PC/AUDIFON H32 PP, manufactured by Trutone. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K972552 · Trutone · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
30d
Days
Class 1
Risk

K972552 is an FDA 510(k) clearance for the AUDIFON H20 PC/AUDIFON H32 PP. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Trutone (Tulsa, US). The FDA issued a Cleared decision on July 30, 1997 after a review of 30 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 Trutone devices

FDA 510(k) Submission Details - K972552

510(k) Number K972552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1997
Decision Date July 30, 1997
Days to Decision 30 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 89d · This submission: 30d
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 K972552.
PHONAK NOVO FORTE E3
K972106 · Phonak, Inc. · Aug 1997
PHONAK EPICA
K972105 · Phonak, Inc. · Aug 1997
PHONAK MICROZOOM P 2
K972097 · Phonak, Inc. · Jul 1997
MIRACLE-EAR DIGITAL BTE
K972344 · Miracle-Ear, Inc. · Jul 1997
DAHLBERG/MIRACLE-EAR
K972345 · Miracle-Ear, Inc. · Jul 1997
MIRACLE-EAR ITE DIGITAL
K972346 · Miracle-Ear, Inc. · Jul 1997