Hearing Aid Feature (HAF)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Apple Inc.
Identifiers
- 510(k) Number
- DEN230081 FDA 510(k)
- FDA Product Code
- SCR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3335 FDA 510(k)
- Regulation Number
- 874.3335 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Hearing Aid Feature (HAF) is a software-based air-conduction hearing aid, classified under 21 CFR 874.3335. It functions as a digital solution designed to amplify and process sound for individuals with self-perceived mild to moderate hearing impairment, leveraging smartphone technology to provide hearing assistance without requiring traditional hardware components.
Supplied as a software update for compatible Apple devices, the HAF operates in a non-sterile, reusable setting and does not require regulatory classifications such as single-use or MRI safety considerations. Authorized under FDA 510(k) clearance (K-number: DEN230081) and MDR compliance, it is intended for use in consumer environments. No physical components or consumables are involved, and its functionality is governed by regulatory standards for Class II medical devices under product code SCR.
Frequently asked questions
What types of hearing impairments does the Hearing Aid Feature (HAF) support, and how does it differ from traditional hearing aids?
The Hearing Aid Feature (HAF) is designed for individuals with self-perceived mild to moderate hearing impairment. Unlike traditional hardware-based hearing aids, HAF is a software solution that runs on compatible Apple devices, eliminating the need for physical components. It amplifies and processes sound digitally, making it a convenient, non-invasive option for users who prefer smartphone-based assistance.
Is the Hearing Aid Feature (HAF) a single-use or reusable device, and what are its environmental requirements?
The HAF is a reusable software-based solution that does not involve physical consumables or hardware. Since it operates entirely within a digital environment on compatible Apple devices, there are no sterility concerns or single-use restrictions. It is intended for use in consumer environments, meaning it does not require specialized storage conditions beyond those of the host device.
How is the Hearing Aid Feature (HAF) supplied, and do I need to purchase additional hardware to use it?
The HAF is supplied as a software update for eligible Apple devices, meaning no additional hardware or consumables are required. Users do not need to purchase separate components—only a compatible Apple device capable of running the update. This makes it a cost-effective, hardware-free solution for hearing assistance.
What regulatory approvals does the Hearing Aid Feature (HAF) hold, and how does this affect its use?
The HAF holds FDA 510(k) clearance (K-number: DEN230081) and complies with the EU Medical Device Regulation (MDR). It is classified as a Class II medical device under product code SCR, meaning it has undergone regulatory review for safety and effectiveness. These approvals confirm its suitability for consumer use in amplifying and processing sound for mild to moderate hearing impairments.
Are there different models or sizes of the Hearing Aid Feature (HAF), or does it come in a standardized form?
Since the HAF is a software-based solution, there are no physical models or sizes to consider. It is a unified digital feature available as an update for compatible Apple devices. The functionality remains consistent across all supported devices, with no variations in performance or configuration.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 099-52715-C HAF 2.X Instructions for Use - regulatoryinfo.apple.com, Usability and Performance of the Apple Over-the-Counter Hearing Aid Feature, PDF DEN230081-S001.Letter, PDF DEN230081 - accessdata.fda.gov
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | DEN230081 | Class II | Active |
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Manufacturer
- Manufacturer
- Apple Inc.
- FDA Applicant
- Apple, Inc.
Sources (2)
- FDA 510(k) DEN230081 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 18, 2026