Anesthesiology
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- MiscellaneousMiscellaneous
- ESIPolymer, Natural-Absorbable Gelatin Material3Product Code
- EWDProtector, Hearing (Insert)UProduct Code
- EWEProtector, Hearing (Circumaural)UProduct Code
- LEZAids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)UProduct Code
- LFAAids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)UProduct Code
- LFBButton, Nasal SeptalUProduct Code
- LRAHearing Aid, TactileUProduct Code
- LXVApparatus, Vestibular AnalysisUProduct Code
- MCMImplant, Cochlear3Product Code
- MHEImplant, Auditory Brainstem3Product Code
- MJVDevice, Inflation, Middle EarUProduct Code
- MPVImplant, Hearing, Active, Middle Ear, Partially Implanted3Product Code
- MRKSystem, Imaging, Fluorescence3Product Code
- QNUTranscutaneous Electrical Nerve Stimulator For The Relief Of Congestion2Product Code
- OAAAid, Visual, For NauseaNProduct Code
- QLVField Generator Positioning Device1Product Code
- EPGStimulator, Transdermal3Product Code
- OAFImplant, Hearing, Active, Middle Ear, Totally Implanted3Product Code
- OAQElectronic Media, HyperacusisNProduct Code
- OWODrug-Eluting Sinus Stent3Product Code
- PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification3Product Code
- QJATympanostomy Tube Delivery Product With Drug3Product Code
- QOOVentilator Tubing And AccessoriesNProduct Code
- QOPRespiratory Humidifier For Emergency UseNProduct Code
- QOSContinuous VentilatorNProduct Code
- QOTEmergency VentilatorNProduct Code
- QOVCritical Care VentilatorNProduct Code
- QOXMulti-Patient Circuit ConnectorNProduct Code
- QQGOropharyngeal Electrical Stimulator2Product Code
- QVNCombined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus2Product Code
- QXGCooperative Powered Surgical Assist Device For Ent Surgery2Product Code
- QZCExternal Mechanical Stimulator For The Relief Of Congestion2Product Code
- SCRAir-Conduction Hearing Aid Software2Product Code
- Submissions with No Product CodeMiscellaneous
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- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Air-Conduction Hearing Aid Software
- Page Type
- Product Code
- 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
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 874.3335
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code SCR is linked to regulation 21CFR874.3335, which does not seem to exist yet. It may be pending at the moment.