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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: LXB FDA class 2

    Hearing Aid, Bone Conduction

    Ear, Nose, Throat

    View full classification →

    The Bone Conduction Hearing Aid (product code LXB) is a hearing device that transmits sound vibrations through the bones of the skull to the cochlea, bypassing the outer and middle ear, and is used by individuals with conductive hearing loss or single-sided deafness. Regulated under 21 CFR 874.3302 and classified as a Class 2 device, it requires a 510(k) premarket notification and is eligible for third-party review. The device falls under the Ear, Nose, and Throat medical specialty. It is not an implant and is not life-sustaining.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
    contact forte Alpha
    Ponto 5 SuperPower
    Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
    Ponto 5 Mini
    Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
    Ponto 4
    ADHEAR System
    Cochlear Baha SoundArc
    Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
    Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
    Baha 5 Power Sound Processor
    Baha 5 Super Power Sound Processor
    Cordelle II Sound Processor
    Baha 5 Sound Processor
    PONTO PLUS AND PONTO PLUS POWER
    OTOMAG BONE CONDUCATION HEARING SYSTEM
    COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
    COCHLEAR BAHA 4 SOUND PROCESSOR
    OTOMAG BONE CONDUCTION HEARING SYSTEM
    AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
    SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
    PONTO PRO POWER
    OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
    BAHA 3 POWER SOUND PROCESSOR
    SOUNDBITE HEARING SYSTEM BY SONITUS
    BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
    OTOMAG BONE CONDUCTION HEARING SYSTEM
    PONTO PRO
    COCHLEAR BAHA BP100
    OBC BONE ANCHORED HEARING AID SYSTEM
    BAHA INTENSO
    TRANSEAR BONE CONDUCTION HEARING AID
    TRANSEAR BONE CONDUCTION HEARING AID
    BAHA DIVINO
    BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
    BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
    HEADBAND FOR BAHA
    BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
    NOBELPHARMA BONE ANCHORED HEARING AID
    SECOND EAR BONE CONDUCTION HEARING AID
    HI SONIC 2000 DIGITAL HEARING INSTRUMENT
    VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
    MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
    XOMED AUDIANT BONE CONDUCTOR
    ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
    XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.
    XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
    AUDIANT BONE CONDUCTOR OR A.B.C.

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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