K220403 is an FDA 510(k) clearance for the Vibe SF Self-Fitting Hearing Aid. This device is classified as a Self-fitting Air-conduction Hearing Aid, Prescription (Class II - Special Controls, product code QDD).
Submitted by Wsaud A/S (Lynge, DK). The FDA issued a Cleared decision on August 12, 2022, 182 days after receiving the submission on February 11, 2022.
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 | K220403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2022 |
| Decision Date | August 12, 2022 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| 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. |