Cleared Traditional

K971296 - TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05

K971296 is an FDA 510(k) clearance for TONDI, manufactured by National Hearing Aid Dist., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K971296 · National Hearing Aid Dist., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
74d
Days
Class 1
Risk

K971296 is an FDA 510(k) clearance for the TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A,.... Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by National Hearing Aid Dist., Inc. (Scarborough, US). The FDA issued a Cleared decision on June 20, 1997 after a review of 74 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 National Hearing Aid Dist., Inc. devices

FDA 510(k) Submission Details - K971296

510(k) Number K971296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date June 20, 1997
Days to Decision 74 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
16d faster than avg
Panel avg: 90d · This submission: 74d
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
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