Cleared Traditional

K890102 - ITC & ITE HEARING AID

K890102 is an FDA 510(k) clearance for ITC & ITE HEARING AID, manufactured by Hear Clear, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K890102 · Hear Clear, Inc. · Ear, Nose, Throat device
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May 1989
Decision
119d
Days
Class 1
Risk

K890102 is an FDA 510(k) clearance for the ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hear Clear, Inc. (San Diego, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 119 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 Hear Clear, Inc. devices

FDA 510(k) Submission Details - K890102

510(k) Number K890102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1989
Decision Date May 11, 1989
Days to Decision 119 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
30d slower than avg
Panel avg: 89d · This submission: 119d
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 K890102.
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
K892338 · Qualitone · Aug 1989
PERSONAL AMPLIFIER MODEL ULTRA HELIX
K893433 · Electone, Inc. · Jun 1989
BEHIND-THE-EAR HEARING AID MODEL 48 PP PC
K892336 · Qualitone · May 1989
BEHIND-THE-EAR HEARING AID MODEL 46 PP PC
K892337 · Qualitone · May 1989
BEHIND-THE-EAR HEARING AID MODEL 408 W-H
K891251 · Siemens Hearing Instruments, Inc. · Mar 1989
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
K891011 · Resound Corp. · Mar 1989