Cleared Traditional

K800105 - TELESONIC (HEARING AID)

K800105 is the FDA 510(k) clearance for TELESONIC (HEARING AID) by Telesonic, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K800105 · Telesonic, Inc. · Ear, Nose, Throat device

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Feb 1980

Decision

26d

Days

Class 1

Risk

K800105 is an FDA 510(k) clearance for the TELESONIC (HEARING AID). 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 February 11, 1980 after a review of 26 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

Submission Details

510(k) Number	K800105 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 16, 1980
Decision Date	February 11, 1980
Days to Decision	26 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

63d faster than avg

Panel avg: 89d · This submission: 26d

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 662

Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K800105.

BEHIND EAR HEARING AID MODEL E24C1

K800244 · Oticon Corp. · Mar 1980

OTICON MODEL E17VF EARETTE HEARING AID

K800283 · Oticon Corp. · Feb 1980

OTICON MODEL E19VF EARETTE HEARING AID

K800316 · Oticon Corp. · Feb 1980

RIONET HEARING AID HE-71

K800011 · Rion Acoustic Instruments, Inc. · Jan 1980

RIONET HEARING AID HA-61

K800012 · Rion Acoustic Instruments, Inc. · Jan 1980

WIDEX HEARING AID MODEL S10

K792389 · Widex Hearing Aid Co., Inc. · Jan 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K800105

Telesonic, Inc.

Mchenry, IL · US

Regulatory profile

12 submissions 12 cleared

100% clearance rate · Active in Ear, Nose, Throat

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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