Search Results

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.

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.

The provided text describes a 510(k) submission for the "Hearing Healthcare Pro" software. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance data often found in novel device approvals.

Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them (especially in the context of typical AI/ML medical device studies with large datasets, expert ground truth, and MRMC studies) is not explicitly available or detailed in this document. The document describes software validation and verification against internal performance specifications and established standards, rather than a clinical performance study with defined acceptance criteria for AI algorithms.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a quantitative acceptance criteria table or specific performance metrics like sensitivity, specificity, accuracy, or AUC for an "abnormal" determination or an "asymmetry" detection. Instead, it states:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document refers to "software validation bench testing" where "HHC Pro input test results" were compared. This implies a test set, but its size (e.g., number of patient cases, number of data points) is not quantified.
• Data Provenance: Not specified regarding country of origin or whether it was retrospective/prospective clinical data or simulated/bench data. The term "input test results" suggests controlled inputs for testing the software's logic.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified. It refers to "Board-Certified Otolaryngologist reviewers" (plural, so at least two).
• Qualifications: "Board-Certified Otolaryngologist". No mention of years of experience.

4. Adjudication method for the test set:

• Not explicitly stated. The document mentions "Board-Certified Otolaryngologist reviewers for equivalence in the output responses." This suggests their output was considered the "gold standard," but the method of reconciliation if there were disagreements among reviewers (e.g., 2+1, consensus, majority vote) is not detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done or reported. The device is described as "compiling 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." It's a screening tool that summarizes inputted data and provides a determination/recommendation, not an AI to assist human image interpretation that would typically warrant an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• The study described is essentially a standalone (algorithm only) validation in the sense that the software's classification outputs ("normal"/"abnormal" determination, "asymmetry" detection) were compared to the "gold standard" established by Otolaryngologist reviewers. The "inputs" to the software are measurements and observations (like audiometry results, tympanometry results, physical examination findings, patient history) provided by a human user, meaning it's a computational device processing structured input data to produce an output, rather than interpreting raw medical images or signals directly. The validation appears to focus on the correctness of this processing logic.

7. The type of ground truth used:

• Expert Consensus / Expert Review: The ground truth for the software's output (e.g., "normal" or "abnormal" determination, "asymmetry" identification) was established by "Board-Certified Otolaryngologist reviewers."

8. The sample size for the training set:

• Not applicable / Not specified. This device is presented as a software that processes user-inputted audiometric, tympanometric, and clinical data based on predefined rules (e.g., >20dB difference for asymmetry), rather than a machine learning model that undergoes a distinct "training phase" on a dataset. The document makes no mention of machine learning, neural networks, or deep learning, which would typically involve a training set. It appears to be a rule-based system or an algorithm with pre-defined thresholds.

9. How the ground truth for the training set was established:

• Not applicable. As implied above, there's no mention of a "training set" in the context of machine learning. If the "algorithm" refers to pre-defined rules, those rules would have been established by clinical knowledge and criteria, not by a data-driven training process. The validation described is focused on verifying the correct application of these rules against expert review.

Ask a specific question about this device

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.

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.

The provided text describes the regulatory filing for the Hearing Healthcare Pro device (K171038). While it mentions performance testing and compliance with standards, it does not provide explicit acceptance criteria or a detailed study report with quantitative performance metrics for the device's determination of "normal" or "abnormal" hearing.

Here's an breakdown based on the information provided, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing. The document states that the device "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." However, it does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or the reported numerical performance values.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing. The document refers to "internal software validation bench testing" and comparing "input test results to the gold standard," but does not specify the sample size of these test cases or the provenance of the data used (e.g., number of patient records, country, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The ground truth was established by "Board-Certified Otolaryngologist reviewers." The number of these experts and their specific qualifications (e.g., years of experience) are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing. The document mentions "Board-Certified Otolaryngologist reviewers" establishing the gold standard, but does not describe the adjudication method used if multiple experts were involved (e.g., consensus, majority vote, independent review).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is intended to assist primary care providers who are not normally trained in audiology, but the document does not detail a study comparing their performance with and without the device. The study described is a comparison of the device's output to expert interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes. The described "internal software validation bench testing" where the "HHC Pro input test results" were compared "to the gold standard, Board-Certified Otolaryngologist reviewers for equivalence in the output responses" suggests a standalone evaluation of the algorithm's performance in making "normal" or "abnormal" determinations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was expert consensus/interpretation by "Board-Certified Otolaryngologist reviewers."

8. The sample size for the training set

Missing. The document discusses software validation for the "HHC Pro" but does not provide information on a training set or its sample size. The description points to a validation of the software's logic against expert opinion rather than a machine learning model that would require a distinct training set.

9. How the ground truth for the training set was established

Missing. As no training set is described for a machine learning model, the method for establishing its ground truth is also not provided. The document focuses on the validation of the device's output against established expert standards.

Ask a specific question about this device