Cleared Traditional

K874589 - BERNAFON COLIBRI, C-2H HEARING AIDS

K874589 is an FDA 510(k) clearance for BERNAFON COLIBRI, manufactured by Bernafon, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K874589 · Bernafon, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
25d
Days
Class 1
Risk

K874589 is an FDA 510(k) clearance for the BERNAFON COLIBRI, C-2H HEARING AIDS. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Bernafon, Inc. (Mountainside, US). The FDA issued a Cleared decision on December 4, 1987 after a review of 25 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.

FDA 510(k) Submission Details - K874589

510(k) Number K874589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date December 04, 1987
Days to Decision 25 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
65d faster than avg
Panel avg: 90d · This submission: 25d
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 1063
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K874589.
POST AURICULAR HEARING AID 46PP-PC SUMMIT
K874707 · Richards Medical Co., Inc. · Dec 1987
OTICON MODEL I50 IN-THE-EAR HEARING AID
K874744 · Oticon Corp. · Dec 1987
NICOLET DIGITAL TWO PIECE HEARING AID
K873736 · Nicolet Biomedical Instruments · Dec 1987
PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL
K874304 · Phonic Ear, Inc. · Nov 1987
INTERNATIONAL MODEL XP BEHIND-THE-EAR
K873798 · Int'L Hearing Aids, Inc. · Oct 1987
INTERNATIONAL MODEL XL BEHIND-THE-EAR
K873799 · Int'L Hearing Aids, Inc. · Oct 1987
K874589 · BERNAFON COLIBRI, C-2H HEARING AIDS
Download PDF Bernafon, Inc.