Cleared Traditional

K931881 - IN THE CANAL AID OTOSONIC ACS II WITH SRR

K931881 is the FDA 510(k) clearance for IN THE CANAL AID OTOSONIC ACS II WITH SRR by Beltone Electronics Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K931881 · Beltone Electronics Corp. · Ear, Nose, Throat device
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Jul 1993
Decision
79d
Days
Class 1
Risk

K931881 is an FDA 510(k) clearance for the IN THE CANAL AID OTOSONIC ACS II WITH SRR. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Beltone Electronics Corp. (Chicago, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 79 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 Beltone Electronics Corp. devices

Submission Details

510(k) Number K931881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1993
Decision Date July 02, 1993
Days to Decision 79 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
10d faster than avg
Panel avg: 89d · This submission: 79d
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 739
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