Cleared Traditional

OTICON I31 CITE HEARING AID

K862980 · Oticon Corp. · Ear, Nose, Throat

Aug 1986

Decision

19d

Days

Class 1

Risk

About This 510(k) Submission

K862980 is an FDA 510(k) clearance for the OTICON I31 CITE 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 August 26, 1986, 19 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	K862980 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 1986
Decision Date	August 26, 1986
Days to Decision	19 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.