Cleared Traditional

K811031 - TELESONIC & ARCON

K811031 is an FDA 510(k) clearance for TELESONIC & ARCON, manufactured by Telesonic, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K811031 · Telesonic, Inc. · Ear, Nose, Throat device
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Jul 1981
Decision
76d
Days
Class 1
Risk

K811031 is an FDA 510(k) clearance for the TELESONIC & ARCON. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Telesonic, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 76 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 Telesonic, Inc. devices

FDA 510(k) Submission Details - K811031

510(k) Number K811031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1981
Decision Date July 01, 1981
Days to Decision 76 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
14d faster than avg
Panel avg: 90d · This submission: 76d
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 954
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K811031.
IN-THE-EAR MODEL 101M
K812939 · Danavox, Inc. · Nov 1981
ELEGANCE
K812578 · Qualitone · Oct 1981
EAGLE I HEARING AID
K811988 · Electone, Inc. · Jul 1981
DAHLBERG MODEL AP HEARING AID
K811578 · Dahlberg Electronics, Inc. · Jul 1981
RIONET HEARING AID HB-69S
K811529 · Rion Acoustic Instruments, Inc. · Jun 1981
RIONET HEARING AID HB 69 T
K811530 · Rion Acoustic Instruments, Inc. · Jun 1981