BEUDAMED
    Product Code: QUH FDA class 2 21 CFR 874.3325

    Self-Fitting Air-Conduction Hearing Aid, Over The Counter

    Ear, Nose, Throat

    The Self-Fitting Air-Conduction Hearing Aid, Over The Counter is a wearable sound-amplifying hearing aid available without a prescription that incorporates self-fitting software technology enabling users to independently program, adjust, and customize their own hearing aid fitting and settings through user input combined with an automated self-fitting strategy. Available under the 2022 OTC Hearing Aid final rule (87 FR 50698), it empowers users to manage their hearing aid without audiological intervention. Classified as FDA Class 2 under regulation 874.3325, it requires 510(k) clearance in the Ear, Nose, and Throat specialty. It is not an implant and not life-sustaining.

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    510(k)s
    9
    FEI Numbers
    29
    Registration Numbers
    29
    Unique Applicants
    9
    Years Active
    1

    Basic Information

    Product Code
    QUH
    Device Class
    FDA class 2
    Regulation Number
    874.3325
    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

    A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K233747 Concha Sol Hearing Aids (CL-1001)
    K233464 WSA Self-Fitting Hearing Aid Gen 2
    K231550 Sontro® OTC Hearing Aids (AI)
    K221052 Self-Fitting hearing aids
    K223848 Intrisound™ Tuned Lumen® 155 Hearing Aids
    K230538 All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
    K223137 Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
    K221698 Eargo 5 , Eargo 6
    K221064 Nuheara IQbuds 2 PRO Hearing Aid

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.