(40 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the hardware and basic signal processing for OAE measurement.
No.
The device is used for determining the presence of cochlear function (diagnosis/screening), not for treating a condition.
Yes
The device determines the presence of cochlear function, which is a diagnostic purpose.
No
The device description explicitly states it is a "hand-held device" with "receivers and microphone built into the screener" and a "DSP board housed in a hand-held device," indicating it includes hardware components.
Based on the provided information, the ERO.SCAN Otoacoustic Emissions Test Instrument is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to "determine the presence of cochlear function" by measuring otoacoustic emissions. This is a diagnostic purpose, aiming to assess a physiological function within the body.
- Mechanism: It measures otoacoustic emissions, which are sounds produced by the inner ear. While the device is external, the measurement is of a biological process occurring within the patient's body.
- Comparison to Predicate: The predicate device (K930553) is also an Otoacoustic Emissions Test Instrument, which are generally classified as diagnostic devices.
While the device is hand-held and applied externally, the core function is to obtain diagnostic information about the internal state of the cochlea. This aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the "specimen" is the otoacoustic emission itself, which is a biological signal.
N/A
Intended Use / Indications for Use
The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held auditory test instrument designed to evoke or stimulate the generation of distortion product otoacoustic emissions (DPOAEs), utilizing pure-tone stimulus presentation, for the purpose of determining the presence of cochlear function in adults, children and infants.
Otoacoustic emissions are low-level audio-frequency sounds that are produced by the cochlea as part of the normal-hearing process. Available evidence suggests that otoacoustic emissions are generated by the cochlea's outer hair cells and that the presence of OAEs is an indication that the outer hair cells are viable. Clinical evidence indicates that these emissions normally occur with normal hearing or, at most, mild hearing loss (usually 30-40 dB HL). The majority of hearing-impaired individuals will be identified by a simple OAE test.
Product codes
EWO
Device Description
The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held device designed to provide an objective measure of outer hair cell function through the measurement of otoacoustic emissions (OAEs).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Cochlea (outer hair cells)
Indicated Patient Age Range
adults, children and infants
Intended User / Care Setting
health care professional
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for Etymotic Research. The logo consists of the letters 'E' and 'R' combined into a single graphic on the left, with the registered trademark symbol above and to the right of the graphic. To the right of the graphic is the text 'ETYMOTIC RESEARCH' in all capital letters.
61 Martin Lane Elk Grove Village, Illinois 60007 (847) 228-0006 (847) 228-6836 Fax
MAR 2 3 1998
February 9, 1998
ERO.SCAN Otoacoustic Emissions Test Instrument
SUMMARY OF SAFETY AND EFFECTIVENESS
| Classification Name: | Audiometer |
|---|---|
| Common/Usual Name: | Otoacoustic Emissions Test Instrument |
| Proprietary Name: | ERO•SCAN Otoacoustic Emissions Test Instrument |
| Establishment Registration: | 1450042 |
| Classification: | Panel 77, Procode EWO Classification 874.1050, Class II |
Steve Iseberg Contact Person:
The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held device designed to provide an objective measure of outer hair cell function through the measurement of otoacoustic emissions (OAEs). This device is substantially equivalent to the marketed Etymotic Research Cub Dis Otoacoustic Emissions Test Instrument, 510(k) No. K930553, September 29, 1993.
Substantial equivalence of the ERO•SCAN instrument to Etymotic Research Cub5Dis predicate device referenced above is based on the following:
- The intended use of the ERO●SCAN device and the predicate test instrument is to . determine cochlear function by measuring distortion product otoacoustic emissions (DPOAEs) utilizing pure-tone stimulus presentation in adults, children and infants.
1
ETYMOTIC RESEARCH
61 Martin Lane Elk Grove Village, Illinois 60007 (847) 228-0006 (847) 228-6836 Fax
- The ERO.SCAN device is manufactured and delivered completely assembled to . the health care professional using materials and techniques widely used by other manufacturers of devices as with the predicate device.
- The ERO.SCAN instrument is battery powered, whereas the predicate device . utilizes AC power to the DSP board and two 9-volt batteries for powering the preamplifier.
- . Patient safety is preserved in both the ERO.SCAN and predicate devices. There is no direct electrical connection to the patient when using the ERO.SCAN unit. The predicate Cub Dis system, if used as intended, provides isolation with the plastic eartips so that there is no path for electrical conductance to the patient.
- The Ear Probe System ERO®SCAN components are similar to those incorporated . in the predicate device, however the physical construction is not the same. The ERO.SCAN system has both receivers and microphone built into the screener. The probe assembly for the predicate Cub-Dis system connects to an external preamplifier that connects to a PC computer-installed DSP board.
- Regarding hardware configurations, the DSP board hardware is housed inside a . PC computer for the predicate device. whereas the ERO.SCAN DSP board is housed in a hand-held device.
- Software algorithms are essentially equivalent for both the ERO.SCAN and ● predicate devices.
- The parameters and principles of the signal processing are essentially the same in both systems with regard to stimulus duration, the use of signal averaging and Fourier transforms, and the fi/f2. fixed ratio of 1.2.
- . The maximum sound level output of the ERO.SCAN Otoacoustic Emissions Test Instrument remains below +90 dB SPL throughout the audible frequency range of 20-20 kHz, which is equal to or less than that of the predicate device.
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இ ETYMOTIC RESEARCH
61 Martin Lane Elk Grove Village, Illinois 60007 (847) 228-0006 (847) 228-6836 Fax
The following comparison is provided as a summary of the technological characteristics relative to the ERO•SCAN Otoacoustic Emission Test Instrument and the predicate Etymotic Research Cub Dis Otoacoustic Emissions Test Instrument upon which the determination of substantial equivalence is based.
| Characteristic | Cub 'Dis System | ERO•SCAN Device |
|---|---|---|
| Intended Use | Auditory test instrument designed to | |
| evoke or stimulate the generation of | ||
| otoacoustic emissions for the purpose of | ||
| determining the presence of cochlear | ||
| function in adults, children and infants. | SAME | |
| Hardware | ||
| Design | DSP board hardware is housed in a PC | |
| computer. The probe assembly is | ||
| connected to an external preamplifier that | ||
| attaches to connections on the board. | DSP board housed in a hand-held | |
| device. | ||
| Software and | ||
| Effectiveness | Software verification and validation is in | |
| accordance with FDA guidelines for | ||
| computer controlled medical devices. QA | ||
| procedures are adhered to and test results | ||
| demonstrate that both system | ||
| specifications and function requirements | ||
| are met to perform DPOAE | ||
| measurements. | SAME | |
| Energy Source | AC power to DSP board with 9-volt | |
| battery power to preamplifier. | (4) 1.5v AA Batteries | |
| Ear Probe | ||
| System | External probe system housing 2 | |
| microphones and 2 speakers. | Microphone and receivers are | |
| integrated in the hand-held | ||
| screener. | ||
| Performance | ||
| Characteristics | Noise Floor: 0 dB SPL @ 1 kHz | |
| Frequency Range: 500 Hz – 8 kHz | ||
| Stimulus Intensity Range: | ||
| 40 – 70 dB SPL | ||
| Maximum Output: ≤90 dB SPL | Noise Floor: 0 dB SPL @ 1 kHz | |
| Frequency Range: 2 kHz – 5 kHz | ||
| Stimulus Intensity Range: | ||
| 45 – 65 dB SPL | ||
| Maximum Output: ≤90 dB SPL | ||
| Safety | The predicate Cub 'Dis system, if used as | |
| intended, provides electrical isolation with | ||
| the plastic eartips so that there is no path | ||
| for electrical conductance to the patient. | ||
| Max. output |