Cleared Traditional

K880938 - ITE TYPE HEARING AID ABS MODEL

K880938 is an FDA 510(k) clearance for ITE TYPE HEARING AID ABS MODEL, manufactured by A Better Sound Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K880938 · A Better Sound Corp. · Ear, Nose, Throat device
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May 1988
Decision
67d
Days
Class 1
Risk

K880938 is an FDA 510(k) clearance for the ITE TYPE HEARING AID ABS MODEL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by A Better Sound Corp. (Green Valley, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 67 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 A Better Sound Corp. devices

FDA 510(k) Submission Details - K880938

510(k) Number K880938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1988
Decision Date May 13, 1988
Days to Decision 67 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
22d faster than avg
Panel avg: 89d · This submission: 67d
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 K880938.
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IMPULSE TVC (RICHARDS, OMNI, MARCON)
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STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES
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