Cleared Traditional

CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54

K895140 · Oticon Corp. · Ear, Nose, Throat

Oct 1989

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K895140 is an FDA 510(k) clearance for the CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Oticon Corp. (Somerset, US). The FDA issued a Cleared decision on October 11, 1989, 56 days after receiving the submission on August 16, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K895140 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 1989
Decision Date	October 11, 1989
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

Device Classification

Product Code	ESD — Hearing Aid, Air-conduction, Prescription
Device Class	Class I — 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.