Cleared Traditional

K871522 - TELSTAR MODEL C HEARING AID

K871522 is an FDA 510(k) clearance for TELSTAR MODEL C HEARING AID, manufactured by Telstar Electronics, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K871522 · Telstar Electronics, Inc. · Ear, Nose, Throat device
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Jun 1987
Decision
46d
Days
Class 1
Risk

K871522 is an FDA 510(k) clearance for the TELSTAR MODEL C HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Telstar Electronics, Inc. (Longwood, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 46 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 Telstar Electronics, Inc. devices

FDA 510(k) Submission Details - K871522

510(k) Number K871522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1987
Decision Date June 05, 1987
Days to Decision 46 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
43d faster than avg
Panel avg: 89d · This submission: 46d
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 K871522.
HEARING AID M35/M36 SERIES
K872556 · Electone, Inc. · Jul 1987
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K872555 · Electone, Inc. · Jul 1987
BTE HEARING AID OTICON MODEL E30P
K872017 · Oticon Corp. · Jun 1987
DAHLBERG MODEL UL IN-THE-EAR HEARING AID
K871525 · Dahlberg Electronics, Inc. · May 1987
DAHLBERG MODEL UH IN-THE-EAR HEARING AID
K871524 · Dahlberg Electronics, Inc. · May 1987
3M INSTANT FIT CUSTOM EARMOLD
K870985 · 3M Company · Mar 1987