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U.S. Department of Health and Human Services

Product Classification

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Device air-conduction hearing aid software
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.
Physical State N/A - device is software. The compatible hardware platform(s) is/are physical, but considered separate non-medical product(s).
Technical Method Medical device software that enables a compatible wearable hardware platform to function (together) as a hearing aid. This software may consist of multiple software / firmware modules for multiple hardware platforms, such as for a headworn product (like "smart earbuds") along with a mobile device ("smartphone") product.
Target Area Air-conduction hearing-aid software, when used with compatible hardware platform, provides amplified sound to the ear.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeSCR
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 874.3335
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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