Cleared Traditional

K881299 - ITE HEARING AID

K881299 is an FDA 510(k) clearance for ITE HEARING AID, manufactured by Ear-Tronics, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K881299 · Ear-Tronics, Inc. · Ear, Nose, Throat device
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Aug 1988
Decision
130d
Days
Class 1
Risk

K881299 is an FDA 510(k) clearance for the ITE HEARING AID, EAR-TRONICS MODELS: M1-M23. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Ear-Tronics, Inc. (Cape Coral, US). The FDA issued a Cleared decision on August 5, 1988 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Ear-Tronics, Inc. devices

FDA 510(k) Submission Details - K881299

510(k) Number K881299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date August 05, 1988
Days to Decision 130 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 89d · This submission: 130d
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 K881299.
HEARING AID, UNITRON MODEL VISTA 1000
K883513 · Unitron Industries, Inc. · Sep 1988
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
K882691 · Maico Hearing Instruments, Inc. · Aug 1988
HEARING AID, UNITRON MODEL UI5
K882375 · Unitron Industries, Inc. · Aug 1988
MODEL P20/P21 IN-THE-EAR HEARING AID
K882692 · Maico Hearing Instruments, Inc. · Jul 1988
DAHLBERG MODEL GP BODY AID
K881417 · Dahlberg Electronics, Inc. · Jun 1988
DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID
K881612 · Dahlberg Electronics, Inc. · Jun 1988