Cleared Special

Bose SoundControl Hearing Aids

K211008 · Bose Corporation · Ear, Nose, Throat

May 2021

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K211008 is an FDA 510(k) clearance for the Bose SoundControl Hearing Aids, a Self-fitting Air-conduction Hearing Aid, Prescription (Class II — Special Controls, product code QDD), submitted by Bose Corporation (Framingham, US). The FDA issued a Cleared decision on May 5, 2021, 30 days after receiving the submission on April 5, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3325.

Submission Details

510(k) Number	K211008 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2021
Decision Date	May 05, 2021
Days to Decision	30 days
Submission Type	Special
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.