Cleared Traditional

OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID

K893528 · Oticon Corp. · Ear, Nose, Throat

Aug 1989

Decision

99d

Days

Class 1

Risk

About This 510(k) Submission

K893528 is an FDA 510(k) clearance for the OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID, 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 August 15, 1989, 99 days after receiving the submission on May 8, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K893528 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 1989
Decision Date	August 15, 1989
Days to Decision	99 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.