Cleared Traditional

K973665 - MAGNATONE / STERLING/ ST

Also marketed or referenced as:
MAGNATONE/DB MAGNATONE/ LIBERTY/ LB MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER

K973665 is an FDA 510(k) clearance for MAGNATONE / STERLING/ ST, manufactured by Magnatone Hearing Aid Corp.. 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.

K973665 · Magnatone Hearing Aid Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
40d
Days
Class 1
Risk

K973665 is an FDA 510(k) clearance for the MAGNATONE / STERLING/ ST. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Magnatone Hearing Aid Corp. (Casselberry, US). The FDA issued a Cleared decision on November 4, 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 Magnatone Hearing Aid Corp. devices

FDA 510(k) Submission Details - K973665

510(k) Number K973665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1997
Decision Date November 04, 1997
Days to Decision 40 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
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 K973665.
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
K974340 · Unitron Industries, Inc. · Dec 1997
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
K973927 · Hyunjae Corp. · Dec 1997
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
K973861 · Magnatone Hearing Aid Corp. · Nov 1997
OTICON DIGISOUND ITE
K973885 · Oticon, Inc. · Nov 1997
OTICON DIGISOUND COMPACT
K973886 · Oticon, Inc. · Nov 1997
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
K973972 · Perfect Ear · Nov 1997