DEN180026 is an FDA 510(k) submission for the Bose Hearing Aid. 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 Not Cleared (DENG) decision on October 5, 2018.
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 | DEN180026 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 11, 2018 |
| Decision Date | October 05, 2018 |
| Days to Decision | 147 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| 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. |