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510(k) Data Aggregation

    K Number
    K232999
    Device Name
    Lyric4 Hearing Aid
    Manufacturer
    Sonova AG
    Date Cleared
    2024-04-11

    (202 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sonova AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hearing aid is intended to be used to amplify and transmit sound to the ear and thereby compensate for impaired hearing. The hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is initially placed in the ear canal by an appropriately trained ENT physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. It is then replaced by a new device by the previously mentioned parties, or by an adult patient 22 years and older who have been wearing Lyric for a minimum period of 3 months under the direction and training of the ENT physician, Audiologist or Hearing Aid Dispenser. Upon device removal the hearing aid is discarded.
    Device Description
    Lyric4 is a non-sterile, extended wear hearing aid that is worn 24 hours a day, 7 days a week for months-at-a-time. Due to the deep placement inside the ear canal, it is 100% invisible. For patients, Lyric4 is very easy to operate with no batteries to change, no ongoing maintenance required and no daily insertion or removal. Lyric4 takes advantage of the deep placement in the ear canal for natural sound quality and the natural directivity of the pinna. Lyric4 is designed for single insertion and is not reused once removed from the ear (single-use only). Compared to the currently marketed Lyric4, there are no modifications to the technology (hardware and software), materials, or accessories when Lyric4 is used for self-replacement. Only the indications for use statement and labeling have been modified.
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    K Number
    K230538
    Device Name
    All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
    Manufacturer
    Sonova AG
    Date Cleared
    2023-06-16

    (109 days)

    Product Code
    QUH
    Regulation Number
    874.3325
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sonova AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The All-Day Clear Slim hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear Slim hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear Slim hearing aids through Android and Apple iOS smartphones. The All-Day Clear hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear hearing aids through Android and Apple iOS smartphones.
    Device Description
    The All-Day Clear Slim ADCS1 hearing aid and All-Day Clear ADC1 hearing aid are self-fitting air-conduction hearing aids. The ADCS1 and ADC1 hearing aids are nearly identical except for minor design differences. The hearing aid system consists of hearing aids for left and right ears, charging case, charging cable with USB-A and USB-C connector, wall plug, a set of eartips (small, medium, and large sizes), cleaning brush, carrying case (for ADCS1 hearing aids alone), and wax guards. The ADCS1 and ADC1 hearing aids are indicated for over-the-counter use. The end user can self-fit the hearing aid by downloading the All-Day Clear App to their Android or Apple iOS device, pairing the hearing aids to the App, and following a series of guided onboarding steps: - Instructions on how to wear the hearing aids - Creation of a sound profile by listening to sample audio in which the user selects parameters for volume and sound clarity - Selection of sound balance Once the hearing aids have been set up with a sound profile, the App can continue to be used as a remote control of the hearing aids. For example, the end users can use the App to change the volume or mute the hearing aid microphones (together or independently), switch between different hearing aid sound modes, adjust the volume of a streamed signal, adjust equalizer and wind noise control, and read out the status of the hearing aid charge level. The ADCS1 and ADC1 hearing aid system provides an alternative optional method of fitting the device by letting the end users purchase "In-Clinic Care Package", where they can have a licensed hearing care professional fit their hearing aids using professional fitting software called "All-Day Clear Fitting Software." All-Day Clear Fitting Software is a component of Sonova's TrueFit 5.3 or higher fitting software which can only be used by a licensed hearing care professional. In both scenarios, the end users can use the App as a remote control of the hearing aid.
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