BEUDAMED
    Product Code: SCR FDA class 2 21 CFR 874.3335

    Air-Conduction Hearing Aid Software

    Ear, Nose, Throat

    Air-conduction hearing aid software is a device intended for use with a compatible wearable hardware platform to compensate for impaired hearing, with software that also allows customization to the user's individual hearing needs; the device is subject to the applicable OTC hearing aid requirements and does not include software used with hardware classified under other hearing aid device regulations. It is classified as FDA Class II (510(k) required) under regulation 874.3335 in the Ear, Nose, Throat specialty, with product code SCR. The device is not an implant and does not support life-sustaining functions.

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    510(k)s
    3
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    3
    Years Active
    1

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    Basic Information

    Product Code
    SCR
    Device Class
    FDA class 2
    Regulation Number
    874.3335
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K251208 Tuned Self-Fitting Mobile App
    K243150 Nuance Audio Hearing Aid Software
    DEN230081 Hearing Aid Feature (HAF)

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.