Cleared Traditional

TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 (K971296) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 89d · This submission: 74d
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 18
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K971296.
Lyric4 Hearing Aid
K232999 · Sonova AG · Apr 2024
3M MODEL 8295
K954067 · 3M Company · Sep 1995
3M MODEL 8200P MULTIPRO BTE
K953543 · 3M Company · Aug 1995
3M MODEL 8233 HEARING INSTRUMENT
K943854 · 3M Company · Jan 1995
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
K935095 · 3M Company · Dec 1993
MODEL 80 HEARING AID DISPENSING SYSTEM
K913245 · 3M Company · Oct 1991