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510(k) DEN230081

Hearing Aid Feature (HAF) by Apple, Inc. — Product Code SCR

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 12, 2024
Date Received
December 4, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Air-Conduction Hearing Aid Software
Device Class
Class II
Regulation Number
874.3335
Review Panel
EN
Submission Type

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.

Other clearances by Apple, Inc.

  • K250507 — Hypertension Notification Feature (HTNF) (September 11, 2025)
  • K250143 — Digital Prism Correction Feature (DPCF) (June 23, 2025)
  • K242058 — Digital Prism Correction Feature (DPCF) (October 21, 2024)
  • K240929 — Sleep Apnea Notification Feature (SANF) (September 13, 2024)
  • K231173 — Irregular Rhythm Notification Feature (IRNF) (July 21, 2023)
  • K213971 — Atrial Fibrillation History Feature (June 3, 2022)
  • K212516 — IRNF App (October 22, 2021)
  • K201525 — ECG App (October 8, 2020)
  • DEN180042 — Irregular Rhythm Notification Feature (September 11, 2018)
  • DEN180044 — ECG App (September 11, 2018)

Other clearances for product code SCR

  • K251208 — Tuned Self-Fitting Mobile App (September 26, 2025)
  • K243150 — Nuance Audio Hearing Aid Software (January 31, 2025)