(257 days)
The iHearTest is an air-conduction over the counter hearing screener for profiling your hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. Hearing test results are displayed on the computer screen and stored in our HIPAA-compliant remote server for review anytime using secure online access.
The iHearTest is an over the counter (OTC) hearing screener for profiling hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. The iHearTest Software System consists of: The iHearUSB device for connection to a personal computer via USB port. Factory calibrated in-ear earphones, marked for right and left ears, with 3 tip sizes. iHearTest software application. Instructions and warranty information provided in the User Guide and online. A quick Install guide to assist in the initial software installation, registering the USB device, and initiating the iHearTest. The iHearTest Software System requires a standard personal computer (PC) with USB port running Microsoft Windows or OS X. The iHearTest software application is a browser-based software application executed from the consumer's personal computer that provides the user interface for a hearing screening test on the PC's monitor, controls the output of test sound signals from an iHearUSB device connected to the PC's USB port, displays hearing test results and sends the results to a remote HIPAA compliant server for review anytime by the consumer using secure online access, and conducts periodic checks of earphone calibration via the calibration tool incorporated into the iHearUSB device. The iHearTest kit is designed to produce air-conducted sounds via the in-ear earphone within the supra-threshold range of 25-85 dB HL at test frequencies of 500, 1000, 2000 and 4000 Hz. The iHearTest software application prompts the user to respond to test sounds and determines the individual's hearing level at each test frequency. The user's overall hearing ability is then computed and displayed for both the right and left ear with a recommendation for potential hearing aid use as per WHO guidelines. The iHearUSB device incorporates a microphone for sensing the background noise during the hearing screening process, and ensuring that the background noise is within an acceptable level range.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Device Performance (Reported Value) | Unit |
|---|---|---|
| Identification of disabling hearing impairment (WHO levels 2-4) agreement with WHO method | 96.4% | Agreement |
| Sensitivity for identification of disabling hearing impairment | 95% | Percentage |
| Specificity for identification of disabling hearing impairment | 97% | Percentage |
| Level-by-level (WHO grades 0-4) agreement with WHO grading | 85.9% | Agreement |
| Agreement within ±1 level with respect to WHO grading | 100% | Agreement |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 96 subjects (192 ears)
- Data Provenance: The document does not explicitly state the country of origin.
- Retrospective or Prospective: Prospective, as it was an "Institutional Review Board (IRB)-approved clinical study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience). It refers to "standard practice audiometry" and the "WHO method for determining hearing impairment" as the basis for ground truth. This implies that audiologists or other qualified healthcare professionals would have performed and interpreted these standard tests.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method like 2+1 or 3+1. It states that "The iHearTest scoring results were compared to World Health Organization (WHO) grading of hearing impairment using standard practice audiometry." This suggests a direct comparison against the results of the standard practice, rather than an adjudication process involving multiple readers of the iHearTest results themselves.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers using AI assistance versus without AI assistance. The study described compares the iHearTest device's performance to an established standard (WHO grading using standard practice audiometry). The iHearTest is presented as a standalone screening device for home use, not as an AI-assisted tool for professionals.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was done. The "iHearTest" is described as an "over the counter (OTC) hearing screener" intended for "home use by adults of at least 18 years of age," with results displayed on a computer screen. The clinical study assessed the "safety and efficacy of the iHearTest as a home air-conduction hearing screener," comparing its results to standard audiometry. This directly reflects the device's standalone performance without human expert interpretation of the iHearTest's output.
7. The Type of Ground Truth Used
The ground truth used was based on expert consensus/standard practice audiometry interpreted according to World Health Organization (WHO) guidelines for determining hearing impairment.
8. The Sample Size for the Training Set
The document does not provide information about the sample size used for the training set. The clinical study described in the summary is referred to as "the iHearTest clinical study" which was conducted to "assess the safety and efficacy" and "determine identification of disabling hearing impairment," implying it was a test set for performance evaluation, not for training.
9. How the Ground Truth for the Training Set Was Established
Since information about a specific training set and its ground truth establishment is not provided, this question cannot be answered from the given document. The document focuses on the validation of the device's performance against established clinical standards.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.