(107 days)
Not Found
No
The description focuses on rule-based logic (summarizing data, applying a 20 dB threshold for asymmetry) and does not mention AI or ML terms or concepts. The validation is against a gold standard of human reviewers, not a training/test set typical of ML.
No
The device is described as a "screening product" that summarizes inputted data and provides a "normal" or "abnormal" determination, and can make "recommendation for clinical follow-up." It is "not intended to make a clinical diagnosis." These functions are diagnostic or screening in nature, not therapeutic.
No
The document explicitly states multiple times that "The HHC Pro software is not intended to make a clinical diagnosis." Instead, it is described as a "screening product" that aggregates data to "determine whether the person's hearing is considered normal or abnormal" and can recommend follow-up.
No
The device description explicitly states that the HHC Pro device comprises the HHC Pro Software and that dB Diagnostic Systems distributes hardware components with the software, including digital audiometers, a tuning fork, and a tablet. This indicates it is not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological specimens: IVDs are designed to examine samples taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes clinical data: The Hearing Healthcare Pro software processes data from audiometry tests, user input of tympanometry results, physical examination results, and patient history. It does not analyze biological specimens.
- The intended use is for hearing assessment and screening: The software is used to capture, summarize, and interpret data related to hearing function and history, not to diagnose conditions based on biological samples.
Therefore, the Hearing Healthcare Pro software falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
ETY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, hearing
Indicated Patient Age Range
adult use only
Intended User / Care Setting
healthcare providers not normally trained or experienced in hearing, audiology, or otology, such as primary care providers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The HHC Pro has been tested and is in compliance with internal software validation bench testing to compare the HHC Pro input test results to the gold standard, Board-Certified Otolaryngologist reviewers for equivalence in the output responses. In addition to the software validation bench testing performed, software verification was also conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met the design requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
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March 6. 2019
dB Diagnostic Systems, Inc. % Scott Blood Regulatory Consultant MEDIcept, Inc. 200 Homer Avenue Ashland. Massachusetts 01721
Re: K183201
Trade/Device Name: Hearing Healthcare Pro Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: November 15, 2018 Received: November 19, 2018
Dear Scott Blood:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183201
Device Name Hearing Healthcare Pro
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
for the dB Diagnostic Systems, Inc. Hearing Healthcare Pro (per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
dB Diagnostic Systems, Inc.
| Official Contact: | Dr. Steven Levine |
|---|---|
| Telephone: | 203-984-0240 |
| Consultant: | Scott Blood |
| MEDIcept, Inc. | |
| 200 Homer Ave | |
| Ashland, MA 01721 |
Date Prepared: November 15, 2018
2. DEVICE NAME
| Proprietary Name: | Hearing Healthcare Pro |
|---|---|
| Common/Usual Name: | Hearing Healthcare Pro |
| Classification Name: | Tester, Auditory Impedance |
| Regulation Number: | 21 CFR 874.1090 |
| Product Code: | ETY |
| Classification Panel: | Ear Nose & Throat |
| Device Classification: | II |
3. PREDICATE DEVICE
K171038 - Hearing Healthcare Pro manufactured by dB Diagnostic Systems, Inc.
4. 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.
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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.
5. INTENDED USE / INDICATIONS FOR 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.
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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The modified HHC Pro device is similar to HHC Pro device currently cleared under K171038 in that both devices include software intended to compile hearing screening information. The software in both systems collects information from portable hearing testing equipment and provides output based on the information provided. Both capture audiometry results from a third-party pure tone audiometer and allows health care professionals (HCPs) to record patient history, otoscopic examination, and tympanometry results. Both provides recommendations for HCPs. Both devices are comprised only of software, an audiometer is sold with the device. Both devices are classified under FDA product code of ETY, Tester, Auditory Impedance.
The modified HHC Pro device differs from the HHC Pro device currently cleared under K171038 in the following areas (1) updating the Indications for Use statement to allow for the device usage by licensed Ear, Nose and Throat (ENT) physicians, (2) allowing for the distribution and use of the device with the OTOpod audiometer in addition to the Amplitude T4 audiometer already distributed with the cleared device, both known as "digital audiometer"(s), and (3) changes to the Recommendations field of the graphical user interface depending on the physician type using the device, and (4) adding the suggestion of bilateral symmetrical or asymmetrical sensorineural hearing loss to possible abnormal hearing test results.
The Hearing Healthcare Pro is substantially equivalent to the predicate device, as it has similar indications for use, and the exact same operational characteristics and fundamental technological characteristics as the HHC Pro device currently cleared under K171038.
7. PERFORMANCE TESTING
The dB Diagnostic Systems, Inc. HHC Pro has been designed and manufactured in compliance with the company's performance specifications and the following FDA recognized consensus standards, voluntary industry standards, and FDA guidance documents:
- AAMI / ANSI / ISO 15223-1: 2012, Medical devices symbols to be used with . medical devices labels, labeling, and information to be supplied - part 1: general requirements. (General I (QS/RM))
- ISO 14971:2007, Medical devices - Application of risk management to medical devices
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- ANSI S3.1-1999 (R2008) American National Standard Maximum Permissible ● Ambient Noise Levels for Audiometric Test Rooms
- FDA Guidance Document, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11. 2002
- FDA Guidance Document, Guidance for the content of Premarket Submission ● for Software in Medical Devices, May 11, 2005
The HHC Pro has been tested and is in compliance with internal software validation bench testing to compare the HHC Pro input test results to the gold standard, Board-Certified Otolaryngologist reviewers for equivalence in the output responses. In addition to the software validation bench testing performed, software verification was also conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met the design requirements.
8. CONCLUSION
The Hearing Healthcare Pro does not raise new issues of safety or effectiveness and is substantially equivalent to the predicate device.