Cleared Traditional

K934618 - OTOSONIC ADVANCED FULL SHIELD (AFS)

K934618 is the FDA 510(k) clearance for OTOSONIC ADVANCED FULL SHIELD (AFS) 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 53-day FDA review.

K934618 · Beltone Electronics Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
53d
Days
Class 1
Risk

K934618 is an FDA 510(k) clearance for the OTOSONIC ADVANCED FULL SHIELD (AFS). 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 November 19, 1993 after a review of 53 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 K934618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1993
Decision Date November 19, 1993
Days to Decision 53 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 89d · This submission: 53d
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
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K934618.
RIONET HEARING AID HA-73
K934480 · Authorized Hearing Systems, Inc. · Nov 1993
PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID
K934586 · Unitron Industries, Inc. · Nov 1993
CLARIFIER II CIRCUIT OPTION
K934597 · Miracle-Ear, Inc. · Nov 1993
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K931372 · Resound Corp. · Nov 1993
STARKEY TYMPANETTE HEARING AID
K933407 · Starkey Laboratories, Inc. · Oct 1993
BOSCH EUROSTAR
K933988 · Starkey Laboratories, Inc. · Oct 1993