(98 days)
The device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages.
The device ABR module is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for the ABR module is newborns and infants up to 6 months of age.
The easyScreen is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.
The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.
easyScreen features a touch-screen display and user-friendly software in a compact hardware design. easyScreen can be purchased with various licenses allowing you to perform different hearing screening tests.
easyScreen uses auditory brainstem response (ABR) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp , of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity.
The EEG is processed and analyzed automatically using the easyScreen's response detection algorithm. When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned.
Auditory brainstem response (ABR) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.
Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.
Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.
The easyScreen consists of a handheld unit that utilizes a touchscreen display and a rechargeable battery. A simple cradle is included to support charging of the device's battery. The device supports Bluetooth communication with a label printer for the purpose of printing screening results.
The provided document does not contain an acceptance criterion table or a detailed study description with specific performance metrics. It's a 510(k) clearance letter and associated summary information for the "easyScreen" audiometric device, establishing substantial equivalence to predicate devices rather than providing detailed performance study results against specific criteria.
However, based on the information provided, here's what can be extracted regarding the device and its assessment:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for a study. Instead, the equivalence charts compare technical specifications and features of the easyScreen to its predicate devices, implying that meeting these comparable specifications is the "performance" considered for substantial equivalence.
Implied Performance Benchmarks from Predicate Comparison:
| Feature/Characteristic | Predicate Device (Titan) Performance/Specification | easyScreen (New Device) Performance/Specification | Note on "Acceptance" (Implied) |
|---|---|---|---|
| TEOAE Stimulus | |||
| Frequency Range | 500 to 5500Hz | same | Equivalent |
| Stimuli Type | Non-Linear and Linear Short duration signal (Click) According to IEC 60645-3 | same | Equivalent |
| Level | 30 to 90 dB peSPL | same | Equivalent |
| Level Step | 1 dB SPL | same | Equivalent |
| TEOAE Recording | |||
| A/D Resolution | 24 bit | same | Equivalent |
| Artifact Reject System | 0 -> +60 dB SPL or off | same | Equivalent |
| Automatic test with display of PASS-REFER | Yes | same | Equivalent |
| ABR Stimulus | |||
| Stimulus | Click and Chirps | same | Equivalent |
| Stimulus Rate | 90/s | same | Equivalent |
| Stimulus Level | 30, 40 and 45dB HL | same | Equivalent |
| Masking | None | same | Equivalent |
| ABR Electrode Features | |||
| Electrode quality check | YES | same | Equivalent |
| Impedance Test | Before recording: Electrode impedance is measured if they are above 10kOhm, below 10 kOhm or below 3 kOhm. | Similar impedance test; acceptable impedance |
§ 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.