Search Results

The Otoport Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear "Pass' or 'Refer' result is presented to the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization.

Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional.

The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.

The Otodynamics Ltd ("Otodynamics") Otoport Pro device is a compact handheld device capable of high quality OAE measurements for clinical purposes and also automated ABR and OAE testing for fast infant screening.

Responses to sound are recorded via an applied earphone and or adhesive surface electrode pad. Specifically, the device can record Otoacoustic Emissions (type DPOAEs or TEOAEs) and auditory brainstem responses (ABRs) to sound. These responses are especially useful in the hearing of infants for deafness. The more detailed analysis of DPOAE and TEOAE responses is additionally useful as a component of the audiological diagnostic test battery.

The Otoport Pro is simple to use with customizable automation to make testing easy and the results clear. It has user access controls, graphical display panel, and extensive test database features. The Otoport Pro when configured for clinical use has advanced test features including extensive raw data capture for offline review and analysis if required.

Otoport Pro device is a hardware/ software revision of the currently marketed Otoport OAE+ABR, having the same performance and intended uses as the Otoport OAE+ABR device.

Here's a breakdown of the acceptance criteria and study information for the Otoport Pro device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance of the Otoport Pro in comparison to its predicate device (Otoport OAE+ABR, K143395) rather than setting distinct acceptance criteria with specific threshold values. The primary acceptance criterion appears to be demonstrating substantial equivalence in performance to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Sizes:
  • TEOAE Screening: 17 subjects
  • DPOAE Screening: 16 subjects
  • AABR Screening: 14 subjects
  • Clinical Measurement TEOAE/DPOAE: 15 subjects (implied for DPOAE, TEOAE not explicitly stated as separate for clinical but likely from the same cohort)
• Data Provenance: The study was conducted on a cohort of adult volunteers who gave informed consent. The tests were performed in a sound booth by a qualified audiologist. This indicates a prospective study design conducted under controlled conditions. The country of origin is not explicitly stated, but the manufacturer is Otodynamics Ltd, based in the United Kingdom.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document states that tests were conducted "by a qualified audiologist." This suggests at least one qualified audiologist was involved in performing the tests and likely verifying the outcomes. Their specific qualifications (e.g., years of experience) are not detailed beyond "qualified audiologist." For AABR, the predicate device was audiologically calibrated on 25 healthy young adults, which speaks to a baseline calibration process rather than ground truth for the test set itself.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "ground truth" for the screening portion appears to be established by the consistent "Pass" or "Refer" results from both the predicate and subject devices, performed by a qualified audiologist. Discrepancies were not noted, suggesting high agreement between devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not reported. The study focused on comparing the Otoport Pro's performance directly against the predicate device, not on assessing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the core of the clinical performance testing for screening modes (TEOAE, DPOAE, AABR) is essentially a standalone assessment of the device's automatic interpretation capabilities ("Pass" or "Refer" results are automatically interpreted and presented to the user). The audiologist's role was to perform the test, implying they observed the device's outcome, but the Pass/Refer decision was made by the device itself and then compared to the predicate's automated output.

7. Type of Ground Truth Used

The ground truth for the clinical performance testing (screening results) appears to be based on:

• Comparison to a Legally Marketed Predicate Device (Otoport OAE+ABR): The consistency of "Pass" or "Refer" results between the Otoport Pro and the predicate device, performed on the same subjects, served as the primary method to establish substantial equivalence.
• Expert Observational Consensus: The tests were conducted by a "qualified audiologist," suggesting that the audiologist's observation and the predicate device's established performance provided the reference.
• Objective Physiological Measurements: The device measures objective physiological responses (OAEs and ABRs) and provides an automated interpretation. The ground truth essentially relied on the established reliable performance of the predicate device for such measurements.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for any training set. The device is presented as a hardware/software revision with the same underlying principles and response analysis techniques as the predicate. This suggests that the "training" (development and refinement of internal algorithms for interpretation) largely predates this submission and was established with the predicate device, or that the algorithm is based on well-understood physiological models rather than machine learning on a large dataset.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned for the Otoport Pro as a new algorithmic development, the method for establishing its ground truth for training is not provided. Given the nature of the device (audiometer with established physiological measurement techniques) and its comparison to a predicate, it's highly probable that the underlying algorithms for interpreting OAE and ABR responses were developed based on physiological and audiological research, clinical guidelines, and extensive testing over the lifespan of the predicate device and related technologies, rather than a new machine learning paradigm requiring a distinct, large, and newly defined training set with expert-labeled ground truth for this specific 510(k) submission.

Ask a specific question about this device