K223911 is an FDA 510(k) clearance for the Lumen 155-SF. This device is classified as a Self-fitting Air-conduction Hearing Aid, Prescription (Class II - Special Controls, product code QDD).
Submitted by Intricon Corporation (Arden Hills, US). The FDA issued a Cleared decision on October 17, 2023, 292 days after receiving the submission on December 29, 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 | K223911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2022 |
| Decision Date | October 17, 2023 |
| Days to Decision | 292 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. |