(72 days)
Not Found
No
The document describes automated analysis using a "response detection algorithm" and "PASS/REFER algorithms," but does not mention AI, ML, or any related concepts like neural networks, training data, or complex learning models. The analysis appears to be based on predefined criteria and signal processing rather than adaptive learning.
No
The device is described as audiometric equipment used for testing and measurement, specifically for screening, evaluation, documentation, and diagnosis of auditory and hearing related disorders, not for providing therapy.
Yes
The device's intended use explicitly states its measures are "useful in the screening evaluation, documentation and diagnosis of auditory and hearing related disorders." Additionally, the performance studies mention "an erroneous diagnosis or a delay in delivery of appropriate medical care" as a potential consequence of software malfunction, further indicating its diagnostic role.
No
The device description explicitly states it consists of a "compact hardware design" and a "handheld unit that utilizes a touchscreen display and a rechargeable battery." It also mentions the use of electrodes, a microphone, and Bluetooth communication, all of which are hardware components. While it contains software, it is not solely software.
Based on the provided information, the GSI Novus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- GSI Novus Function: The GSI Novus measures auditory evoked responses (ABR) and otoacoustic emissions (OAE) directly from the patient's ear and head using electrodes and a microphone. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the device as being used for "measurement and automated analysis of auditory evoked responses... and/or otoacoustic emissions." This is a direct physiological measurement, not an analysis of a biological sample.
- Device Description: The description reinforces that the device uses "transcutaneous electrodes" and a "sensitive microphone placed in the patient's ear canal" to measure responses.
Therefore, the GSI Novus falls under the category of a medical device used for physiological measurement and diagnosis, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, documentation and diagnosis of auditory and hearing related disorders. The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages.
The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.
Product codes
EWO, GWJ
Device Description
The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.
Novus features a touch-screen display and user-friendly software in a compact hardware design. Novus can be purchased with various licenses allowing you to perform different hearing screening tests.
Novus 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 Novus'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 Novus 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear and hearing nerves
Indicated Patient Age Range
The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages.
Intended User / Care Setting
The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Design verification and validation were performed according to current standards for OAE and ABR to assure the device meets its performance specifications. EMC and Safety was performed in compliance with recognized standards IEC 60601-1 series, Medical Electrical Equipment – General requirements for basic safety and essential performance. The product meets the requirements from the international standard for OAE measurements IEC 60645 series. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in medical Devices." The software for this device was considered as a "moderate" level of concern since a malfunction of, or a latent design flaw in, the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. The OAE and ABRIS measurements were divided into 3 phases. Phase included when optimization occurred and involved feedback to the operator so that they could adjust such as probe fit, electrode impedance, ambient electrical and acoustic noise etc. Once the pre-test conditions were optimized, phase 2 of data collection proceeded as rapid as possible to allow the maximum quantity of good quality data to be collected in the shortest possible time. Phase 3 proceeded into the data assessment and decision stage and this ran concurrently with Phase 2 once the predetermined minimum amount of data had been collected. Phase 3 then went into the algorithm descriptions for each TEOAE, DPOAE and ABRIS measurements modes. The detailed information about the validation and verification of PASS/REFER algorithms for the OAE and ABR modules is provided in the GSI Novus Manual, e.g., PASS/REFER Criteria, Sensitivity and Specificity etc. No clinical tests were performed, but based on the fulfillment of the international standards for OAE and ABR we believe the device is safe and effective. The auditory impedance testing characteristics and safety systems were compared and found to be comparable.
Key Metrics
Not Found
Predicate Device(s)
Titan with TEOAE440 (K130795), Titan (with DPOAE440 and ABRIS440), cleared on 05/05/2011 via K103760, Titan (with TEOAE440), cleared on 06/20/2013 via K130795
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 20, 2017
Grason-Stadler Inc. Amy Yanta Director of Regulatory Affairs 10395 West 70th Street Eden Prairie, MN 55344
Re: K172403
Trade/Device Name: GSI Novus Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: August 9, 2017 Received: August 9, 2017
Dear Amy Yanta:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling
(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Srinivas Nandkumar -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172403
Device Name GSI Novus
Indications for Use (Describe)
The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, documentation and diagnosis of auditory and hearing related disorders. The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages.
The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in light blue on the left. To the right of the sound wave is the company's acronym "gsi" in bold, black letters. Below the acronym is the full company name, "Grason-Stadler," in a smaller, sans-serif font.
Section 5: 510(k) Summary as required by 21 CFR 807.92.
Administrative Information
- Submitter: Grason-Stadler Inc. 10395 West 70th Street Eden Prairie, MN 55344 Tel: 952-947-6097 Fax: 952-278-4401
Contact Person: Amy Yanta Director of Regulatory Affairs 10393 West 70th Street Eden Prairie, MN 55344 952-947-6097 amyy@diagnostic-group.us
Date Summary Prepared: August 7, 2017
Device Identification
Trade Name: Novus Common Name: otoacoustic emission device/evoked response auditory stimulator and measurements Device Classification Name: Audiometer/Stimulator, Auditory, Evoked Response Device classification: Class II Panel: Ear Nose & Throat / Neurology Classification Regulation: 874.1050/882.1900 Product Code: EWO/GWJ
Predicate Device 1: Titan (with DPOAE440 and ABRIS440), cleared on 05/05/2011 via K103760 Predicate Device 2: Titan (with TEOAE440), cleared on 06/20/2013 via K130795
Device Description
The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.
Novus features a touch-screen display and user-friendly software in a compact hardware design. Novus can be purchased with various licenses allowing you to perform different hearing screening tests.
Novus 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 Novus'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.
4
Image /page/4/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in blue, followed by the letters "gsi" in bold, black font. Below the letters, the words "Grason-Stadler" are written in a smaller, sans-serif font, also in black. The logo is clean and modern, reflecting the company's focus on technology and innovation in the field of audiology.
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.
Device Intended Use
The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, identification, documentation and diagnosis of auditory and hearing related disorders.
The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages.
The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.
Technological Characteristics
The Novus 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.
A comparison between the new and predicate devices shows that the technological characteristics and indications for use are equivalent. The device employs similar technology to accomplish the same tasks as the predicates. A detailed table is provided below.
| Description | Titan with TEOAE440 (K130795) | Novus |
|---|---|---|
| Type | Audiometer | Audiometer |
| Regulation Number | 21 CFR 874.1050 | |
| (otoacoustic emission device) | 21 CFR 874.1050 | |
| (otoacoustic emission device) | ||
| Classification Product Code | EWO | EWO |
| Regulatory Class | Class II | Class II |
| Indications for Use | The Titan with TEOAE440 is intended | |
| for use in the audiologic evaluation | ||
| and documentation of ear disorders | The GSI Novus is intended to | |
| be used for the measurement | ||
| and automated analysis of | ||
| using Transient Evoked Otoacoustic | ||
| Emissions. | ||
| The target population for Titan with | ||
| TEOAE440 includes all ages. | auditory evoked responses | |
| (auditory brainstem | ||
| responses, ABR) and/or | ||
| otoacoustic emissions | ||
| (distortion product, DPOAE | ||
| and transient evoked, TEOAE). | ||
| These measures are useful in | ||
| the screening evaluation, | ||
| identification, documentation | ||
| and diagnosis of auditory and | ||
| hearing related disorders. | ||
| The auditory evoked response | ||
| (ABR) measurement is | ||
| intended for newborns and | ||
| infants up to 6 months of age. | ||
| The otoacoustic emissions | ||
| (DPOAE and/or TEOAE) | ||
| measurement is intended for | ||
| use in patients of all ages. | ||
| The GSI Novus is intended to | ||
| be used by a healthcare | ||
| professional such as an ENT | ||
| doctor, nurse or audiologist or | ||
| by a trained technician under | ||
| the supervision of a | ||
| professional. The device is | ||
| intended to be used in a | ||
| hospital, clinic, or other facility | ||
| with a suitable quiet testing | ||
| environment. | ||
| Intended use differs due to | ||
| the device encompassing all | ||
| functions into one device. | ||
| Target Population | The devices are suitable for all | |
| populations including new-born | ||
| infants | The device are suitable for all | |
| populations including new- | ||
| born infants | ||
| Intended User | The Titan System is to be used by | |
| trained personnel only such as | ||
| audiologists, ENT surgeons, doctors, | ||
| hearing healthcare professionals or | ||
| personnel with a similar level of | ||
| education. | To be used by trained | |
| personnel only such as | ||
| audiologists, ENT surgeons, | ||
| doctors, hearing healthcare | ||
| professionals or personnel | ||
| with similar level of education. | ||
| (or trained user with | ||
| supervision of a professional) | ||
| TEOAE Stimulus | ||
| Frequency Range | 500 to 5500Hz | 500 to 5500Hz |
| Stimuli Type | Non-Linear and Linear | |
| Short duration signal (Click) | ||
| According to IEC 60645-3 | Non-Linear and Linear | |
| Short duration signal (Click) | ||
| According to IEC 60645-3 | ||
| Level | 30 to 90 dB peSPL | 30 to 90 dB peSPL |
| Level Step | 1 dB SPL | 1 dB SPL |
| Transducer | Dedicated OAE Probe | Dedicated OAE Probe |
| Probe Detection | Auto detection | Auto detection |
| Recording | ||
| A/D Resolution | 24 bit | 24 bit |
| Artifact Reject System | 0 -> +60 dB SPL or off | 0 -> +60 dB SPL or off |
| Automatic test with display | ||
| of PASS-REFER | Yes | Yes |
Equivalence Predicate Chart 1:
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Image /page/5/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features a stylized sound wave graphic in blue, followed by the letters "gsi" in bold, black font. Below the letters, the words "Grason-Stadler" are written in a smaller, lighter font.
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Image /page/6/Picture/1 description: The image shows the logo for Grason-Stadler. The logo features a stylized letter 'g' with three curved lines emanating from it, followed by the letters 'si' stacked on top of the words 'Grason-Stadler'. The letter 'g' and the letters 'si' are in black, while the curved lines are in blue.
Equivalence Predicate Chart 2:
| Titan (K103760) | Novus | |||
|---|---|---|---|---|
| Description | With ABRIS440 | With DPOAE440 | With ABRIS | With DPOAE |
| Type | Auditory Brainstem | |||
| Response - | ||||
| Audiometric | ||||
| equipment | Audiometer | Auditory Brainstem | ||
| Response - | ||||
| Audiometric | ||||
| equipment | Audiometer | |||
| Regulation | ||||
| Number | 21 CFR 882.1900 | |||
| (Evoked response | ||||
| auditory | ||||
| stimulator) | 21 CFR 874.1050 | |||
| (otoacoustic | ||||
| emission device) | 21 CFR 882.1900 | |||
| (Evoked response | ||||
| auditory | ||||
| stimulator) | 21 CFR 874.1050 | |||
| (otoacoustic emission | ||||
| device) | ||||
| Classification | ||||
| Product Code | GWJ | EWO | GWJ | EWO |
| Regulatory | ||||
| Class | Class II | Class II | Class II | Class II |
| Indications for | ||||
| Use | The Titan with | |||
| ABRIS440 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 Titan with | |||
| DPOAE440 is | ||||
| intended for use in | ||||
| the audiologic | ||||
| evaluation and | ||||
| documentation of | ||||
| ear disorders using | ||||
| Distortion | ||||
| Product | ||||
| Otoacoustic | ||||
| Emissions. | The GSI Novus is | |||
| intended to be used | ||||
| for the measurement | ||||
| and automated | ||||
| analysis of auditory | ||||
| evoked responses | ||||
| (auditory brainstem | ||||
| responses, ABR) | ||||
| and/or otoacoustic | ||||
| emissions (distortion | ||||
| product, DPOAE and | ||||
| transient evoked, | ||||
| TEOAE). These | ||||
| measures are useful in | ||||
| the screening | ||||
| evaluation, | ||||
| identification, | ||||
| documentation and | ||||
| diagnosis of auditory | The GSI Novus is | |||
| intended to be used | ||||
| for the measurement | ||||
| and automated | ||||
| analysis of auditory | ||||
| evoked responses | ||||
| (auditory brainstem | ||||
| responses, ABR) | ||||
| and/or otoacoustic | ||||
| emissions (distortion | ||||
| product, DPOAE and | ||||
| transient evoked, | ||||
| TEOAE). These | ||||
| measures are useful in | ||||
| the screening | ||||
| evaluation, | ||||
| identification, | ||||
| documentation and | ||||
| diagnosis of auditory | ||||
| and hearing related | and hearing related | |||
| disorders. | ||||
| The auditory evoked | disorders. | |||
| The auditory evoked | ||||
| response (ABR) | ||||
| measurement is | response (ABR) | |||
| measurement is | ||||
| intended for newborns | ||||
| and infants up to 6 | intended for | |||
| newborns and infants | ||||
| months of age. The | up to 6 months of age. | |||
| otoacoustic emissions | ||||
| (DPOAE and/or | The otoacoustic | |||
| emissions (DPOAE | ||||
| TEOAE) measurement | ||||
| is intended for use in | and/or TEOAE) | |||
| measurement is | ||||
| patients of all ages. | ||||
| The GSI Novus is | intended for use in | |||
| patients of all ages. | ||||
| intended to be used by | The GSI Novus is | |||
| a healthcare | intended to be used | |||
| professional such as an | ||||
| ENT doctor, nurse or | by a healthcare | |||
| audiologist or by a | professional such as | |||
| an ENT doctor, nurse | ||||
| trained technician | ||||
| under the supervision | or audiologist or by a | |||
| of a professional. The | ||||
| device is intended to | trained technician | |||
| under the supervision | ||||
| be used in a hospital, | ||||
| clinic, or other facility | of a professional. The | |||
| device is intended to | ||||
| with a suitable quiet | ||||
| testing environment. | be used in a hospital, | |||
| clinic, or other facility | ||||
| with a suitable quiet | ||||
| testing environment. | ||||
| Intended use differs | ||||
| due to the device | ||||
| encompassing all | Intended use differs | |||
| functions into one | due to the device | |||
| device. | encompassing all | |||
| functions into one | ||||
| device. | ||||
| Target | Children and | The patient group | Children and newborn | The patient group |
| Population | newborn | includes all ages | includes all ages and | |
| and sexes. | sexes. | |||
| Anatomical | Examination of Ear | Examination of Ear | Examination of Ear and | Examination of Ear |
| Sites | and hearing nerves | hearing nerves | ||
| Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| Standards | ||||
| Performance | IEC 60645-7 | IEC 60645-6 | IEC 60645-7 | IEC 60645-6 |
| standard | ||||
| Device Type | Screening device | Screening and | Screening and | Screening and |
| (PASS/REFER) result | diagnostic | diagnostic device | diagnostic device | |
| (PASS/REFER) result | (PASS/REFER) result | |||
| System | 1 -channel ABR | 1 -channel ABR system | ||
| Configuration | system operated | operated through a | ||
| through a handheld | handheld base unit. | |||
| base unit. The | The | |||
| base unit can be | ||||
| operated stand | ||||
| alone or PC | ||||
| controlled through | ||||
| USB or Bluetooth. | base unit can be | |||
| operated as stand-alone device. |
This allows the freedom of flexibility.
The data can be transferred to the PC via USB port for secure transmission. | |
| Display
Information | PASS/REFER status, indicated with value between 0 and 100% where 100% indicates a pass. EEG peak or RMS value, rejection status, residual noise and what transducer(s) are detected. | | Noise status, detected transducer, artifact %, PASS/REFER status.
This creates simplicity for user use. | |
| Stimulus | Click and Chirps | 2 pure tones | Click and Chirps | 2 pure tones |
| Electrode
quality check | YES | | YES | |
| 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