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510(k) Data Aggregation
K Number
K183201Device Name
Hearing Healthcare Pro
Manufacturer
dB Diagnostic Systems, Inc.
Date Cleared
2019-03-06
(107 days)
Product Code
ETY
Regulation Number
874.1090Why did this record match?
Applicant Name (Manufacturer) :
dB Diagnostic Systems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hearing Healthcare Pro software will capture audiometry test results, and will allow user input of tympanometry results, physical examination results, and patient history. The software will summarize the inputted data and provide a "normal" or "abnormal" determination. If the decision is "abnormal", the software can make a recommendation for clinical follow-up. The dB Diagnostic Systems, Inc. software is for adult use only and may be used by healthcare providers not normally trained or experienced in hearing, audiology, or otology, such as primary care providers. The Hearing Healthcare Pro software is not intended to make a clinical diagnosis.
Device Description
The Hearing Healthcare (HHC) Pro is software designed to be used by healthcare providers (HCP) either trained and experienced in hearing, audiology, or otology, such as Ear, Nose, and Throat (ENT) doctors or not, such as primary care providers. The HHC Pro software is not intended to make a clinical diagnosis. The HHC Pro software is a screening product. The software aggregates the inputted data and determines whether the person's hearing is considered normal or abnormal. If the results are abnormal, the software can either provide a recommendation for further clinical consultation with a licensed physician with expertise in Ear, Nose and Throat (ENT), or allow for an ENT-trained physician to enter their own recommendation in a blank text field. Further, the software can distinguish between symmetrical and asymmetrical sensorineural hearing loss; the former would be recommended to see an audiologist or an otolaryngologist who works with an audiogist, the latter would be recommended to an ENT clinical specialist. The HHC Pro software compiles the hearing information previously available to physicians, classifies the data as normal or abnormal with respect to any measureable hearing loss, and identifies the presence of asymmetric hearing results. dB Diagnostics has chosen to validate the algorithm determining the difference between the symmetry and asymmetry of hearing loss as a greater that 20 dB difference between two ears at any test frequency (which are 250, 500, 1000, 2000, 6000, and 8000 Hz). The health care provider uses the HHC Pro to enter hand-held tympanometry results, limited clinical history, and limited physical examination findings, including a Rinne tuning fork test at 512Hz, to further identify patients who would benefit from an ENT evaluation. The HHC Pro device comprises the HHC Pro Software. With the HHC Pro Software, dB Diagnostic Systems distributes the Amplitude T4 audiometer or the OTOpod audiometer, both manufactured by Auditdata A/S and collectively known as a "digital audiometer", a 512Hz Rinne tuning fork, and the Microsoft Surface Pro tablet preloaded with the Microsoft Windows 10 operating system and the HHC Pro Software. An Amplivox Otowave 102 Tympanometer may also be distributed with the HHC Pro software.
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K Number
K171038Device Name
Hearing Healthcare Pro
Manufacturer
dB Diagnostic Systems, Inc.
Date Cleared
2017-08-02
(118 days)
Product Code
ETY
Regulation Number
874.1090Why did this record match?
Applicant Name (Manufacturer) :
dB Diagnostic Systems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hearing Healthcare Pro software will capture audiometry test results, and will allow user input of tympanometry results, physical examination results, and patient history. The software will summarize the inputted data and provide a "normal" or "abnormal" determination. If the decision is "abnormal", the software will make a recommendation for clinical follow-up. The dB Diagnostic Systems, Inc. software is for adult use only and is intended to be used by healthcare providers not normally trained or experienced in hearing, audiology, or otology, such as primary care providers.
The Hearing Healthcare Pro software is not intended to make a clinical diagnosis.
Device Description
The Hearing Healthcare (HHC) Pro is software designed to be used by healthcare providers (HCP) not normally trained or experienced in hearing, audiology, or otology, such as primary care providers. The HHC Pro software is not intended to make a clinical diagnosis. The HHC Pro software is a screening product. The software aggregates the inputted data and determines whether the person's hearing is considered normal or abnormal. If the results are abnormal, the software provides a recommendation for further clinical consultation with a licensed physician with expertise in Ear, Nose and Throat (ENT).
The HHC Pro software compiles the hearing information previously available to physicians, classifies the data as normal or abnormal with respect to any measureable hearing loss, and identifies the presence of asymmetric hearing results. The health care provider uses the HHC Pro to enter hand-held tympanometry results, limited clinical history, and limited physical examination findings, including a Rinne tuning fork test at 512Hz, to further identify patients who would benefit from an ENT evaluation.
The HHC Pro device comprises the HHC Pro Software. With the HHC Pro Software. dB Diagnostic Systems distributes the Auditdata/Otovation Amplitude T4 audiometer manufactured by Auditdata A/S, a 512Hz Rinne tuning fork, and the Microsoft Surface Pro 4 tablet preloaded with the Microsoft Windows 10 operating system and the HHC Pro Software. An Amplivox Otowave 102 Tympanometer may also be distributed with the HHC Pro software.
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