K233464 is an FDA 510(k) clearance for the WSA Self-Fitting Hearing Aid Gen 2. This device is classified as a Self-fitting Air-conduction Hearing Aid, Over The Counter (Class II - Special Controls, product code QUH).
Submitted by Wsaud A/S (Lynge, DK). The FDA issued a Cleared decision on February 9, 2024, 109 days after receiving the submission on October 23, 2023.
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 An Over The Counter Hearing Aid. For Information On The Final Rule ?establishing Over-the-counter Hearing Aids,? Please See 87 Fr 50698, Available At Https://www.govinfo.gov/content/pkg/fr-2022-08-17/pdf/2022-17230.pdf..
| 510(k) Number | K233464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2023 |
| Decision Date | February 09, 2024 |
| Days to Decision | 109 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | QUH — Self-fitting Air-conduction Hearing Aid, Over The Counter |
| 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 An Over The Counter Hearing Aid. For Information On The Final Rule ?establishing Over-the-counter Hearing Aids,? Please See 87 Fr 50698, Available At Https://www.govinfo.gov/content/pkg/fr-2022-08-17/pdf/2022-17230.pdf. |