Cleared Traditional

OTICON I31 INITIALES HEARING AID

K862981 · Oticon Corp. · Ear, Nose, Throat

Oct 1986

Decision

69d

Days

Class 1

Risk

About This 510(k) Submission

K862981 is an FDA 510(k) clearance for the OTICON I31 INITIALES HEARING 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 October 15, 1986, 69 days after receiving the submission on August 7, 1986. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K862981 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 1986
Decision Date	October 15, 1986
Days to Decision	69 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.