K211008 is an FDA 510(k) clearance for the Bose SoundControl Hearing Aids. This device is classified as 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 FDA review panel. Regulated under 21 CFR 874.3325. 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..
| 510(k) Number | K211008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |