Cleared Traditional

Jabra Enhance Plus

K213424 · GN Hearing A/S · Ear, Nose, Throat

Jan 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K213424 is an FDA 510(k) clearance for the Jabra Enhance Plus, a Self-fitting Air-conduction Hearing Aid, Prescription (Class II — Special Controls, product code QDD), submitted by GN Hearing A/S (Ballerup, DK). The FDA issued a Cleared decision on January 19, 2022, 90 days after receiving the submission on October 21, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3325.

Submission Details

510(k) Number	K213424 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2021
Decision Date	January 19, 2022
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	QDD — Self-fitting Air-conduction Hearing Aid, Prescription
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.3325
Definition	A Self-fitting Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device That Is Intended To Compensate For Impaired Hearing And Incorporates Technology, Including Software, That Allows Users To Program Their Hearing Aids. This Technology Integrates User Input With A Self-fitting Strategy And Enables Users To Independently Derive And Customize Their Hearing Aid Fitting And Settings. This Is A Prescription Hearing Aid.