DEN230081 is an FDA 510(k) submission for the Hearing Aid Feature (HAF). This device is classified as a Air-conduction Hearing Aid Software (Class II - Special Controls, product code SCR).
Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Not Cleared (DENG) decision on September 12, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3335. Air-conduction Hearing Aid Software Is A Device That Is Intended To Be Used With A Compatible Wearable Hardware Platform To Compensate For Impaired Hearing. The Software Also Allows For Customization To The User's Hearing Needs. Devices In This Classification Are Also Subject To The Requirements In § 800.30 Or § 801.422 Of This Chapter, As Applicable. This Classification Does Not Include Software That Is Used With Hardware As Part Of A Hearing-aid Device System Classified In Other Regulations, E.g., § 874.3300, § 874.3305, Or § 874.3325..
| 510(k) Number | DEN230081 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 04, 2023 |
| Decision Date | September 12, 2024 |
| Days to Decision | 283 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | SCR - Air-conduction Hearing Aid Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3335 |
| Definition | Air-conduction Hearing Aid Software Is A Device That Is Intended To Be Used With A Compatible Wearable Hardware Platform To Compensate For Impaired Hearing. The Software Also Allows For Customization To The User's Hearing Needs. Devices In This Classification Are Also Subject To The Requirements In § 800.30 Or § 801.422 Of This Chapter, As Applicable. This Classification Does Not Include Software That Is Used With Hardware As Part Of A Hearing-aid Device System Classified In Other Regulations, E.g., § 874.3300, § 874.3305, Or § 874.3325. |