Cleared Traditional

K971807 - IN THE EAR

K971807 is an FDA 510(k) clearance for IN THE EAR, manufactured by Hear-Right, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K971807 · Hear-Right, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
84d
Days
Class 1
Risk

K971807 is an FDA 510(k) clearance for the IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hear-Right, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on August 7, 1997 after a review of 84 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 Hear-Right, Inc. devices

FDA 510(k) Submission Details - K971807

510(k) Number K971807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1997
Decision Date August 07, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 89d · This submission: 84d
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 K971807.
PRISMA
K972998 · Siemens Hearing Instruments, Inc. · Sep 1997
AIR CONDUCTION HAEARING AIDS
K971852 · Beltone Electronics Corp. · Aug 1997
PHONAK NOVO FORTE E3
K972106 · Phonak, Inc. · Aug 1997
PHONAK EPICA
K972105 · Phonak, Inc. · Aug 1997
PHONAK MICROZOOM P 2
K972097 · Phonak, Inc. · Jul 1997
MIRACLE-EAR DIGITAL BTE
K972344 · Miracle-Ear, Inc. · Jul 1997