Cleared Traditional

K860512 - TELESTAR I

K860512 is an FDA 510(k) clearance for TELESTAR I, manufactured by The Florida Hearing Aid Service. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K860512 · The Florida Hearing Aid Service · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
34d
Days
Class 1
Risk

K860512 is an FDA 510(k) clearance for the TELESTAR I, HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by The Florida Hearing Aid Service (Casselberrry, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 34 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 The Florida Hearing Aid Service devices

FDA 510(k) Submission Details - K860512

510(k) Number K860512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1986
Decision Date March 17, 1986
Days to Decision 34 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
55d faster than avg
Panel avg: 89d · This submission: 34d
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 K860512.
RIONET HEARING AID
K861728 · Rion Acoustic Instruments, Inc. · May 1986
DAHLBERG MODEL UT IN-THE-EAR HEARING AID
K860670 · Dahlberg Electronics, Inc. · Apr 1986
MODEL 353C HEARING AID
K860035 · Telex Communications, Inc. · Mar 1986
AM 12, HEARING AID
K860007 · Electone, Inc. · Mar 1986
AM 31, HEARING AID
K860008 · Electone, Inc. · Mar 1986
A & M DISCREET - HEARING AID
K860190 · Electone, Inc. · Mar 1986