Cleared Traditional

K810347 - BOSCH STAR 66F SUPER EARLEVEL AID

K810347 is the FDA 510(k) clearance for BOSCH STAR 66F SUPER EARLEVEL AID by Bosch Hearing Instruments, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K810347 · Bosch Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
49d
Days
Class 1
Risk

K810347 is an FDA 510(k) clearance for the BOSCH STAR 66F SUPER EARLEVEL AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Bosch Hearing Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 49 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 Bosch Hearing Instruments, Inc. devices

Submission Details

510(k) Number K810347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1981
Decision Date March 31, 1981
Days to Decision 49 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
40d faster than avg
Panel avg: 89d · This submission: 49d
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 719
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K810347.
HEARING AID, UNITRON MODEL C5-H
K811174 · Unitron Industries, Inc. · May 1981
EARETTE HEARING AID OTICON #E25F
K810986 · Oticon Corp. · May 1981
EARETTE HEARING AID OTICON #E27F
K810987 · Oticon Corp. · May 1981
POWER SONIC
K810577 · Qualitone · Mar 1981
EARETTE HEARING AID OTICON #E27
K810610 · Oticon Corp. · Mar 1981
EARETTE HEARING AID(BEHING THE EAR)
K810576 · Oticon Corp. · Mar 1981