GSI Corti
Device Facts
| Record ID | K180287 |
|---|---|
| Device Name | GSI Corti |
| Applicant | Grason-Stadler, Inc. |
| Product Code | EWO · Ear, Nose, Throat |
| Decision Date | May 11, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1050 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The GSI Corti series is indicated for testing of cochlear function in infants, children and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks that are directed into the ear canal. 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.
Device Story
GSI Corti is a handheld audiometer for measuring Distortion Product Otoacoustic Emissions (DPOAEs) and Transient Evoked Otoacoustic Emissions (TEOAEs). Device inputs: acoustic signals generated by internal hardware and reflected from the ear canal via a probe containing a speaker and microphone. Operation: device generates pure tones (DPOAE) or wideband clicks (TEOAE) directed into the ear canal; internal signal processing separates noise from emissions using band-pass filters; results displayed on OLED screen. Used in clinical settings by healthcare professionals. Output: pass/fail status, emission levels, and signal-to-noise ratios. Data stored in internal flash EEPROM; results can be printed via Bluetooth-connected thermal printer. Device aids clinicians in identifying hearing impairment by assessing outer hair cell function. Benefits include rapid, non-invasive screening and diagnostic evaluation of cochlear health.
Clinical Evidence
Clinical validation compared GSI Corti to the ERO-SCAN predicate. Study evaluated DPOAE and TEOAE performance across a population of approximately 80% normal hearing and 20% hearing-impaired subjects. Endpoints included overall test results, signal-to-noise ratio at each frequency, emission levels, and noise floor. Results demonstrated equivalent diagnostic performance to the predicate device, confirming the device meets requirements for cochlear function evaluation.
Technological Characteristics
Handheld audiometer; PC+ABS CX7240 housing; machined aluminum probe; OLED display; 4-button navigation. Power: rechargeable Li-ion battery. Connectivity: USB A to micro-B, Bluetooth for printing. Standards: AAMI/ANSI S3.6:2010, IEC 60645-1:2012, IEC 60645-3:2007, IEC 60645-6:2009, IEC 60601-1:2005+A1:2012. Software: moderate level of concern. In-ear self-calibration.
Indications for Use
Indicated for testing cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs) to assess outer hair cell viability. Suitable for individuals with normal hearing or mild hearing loss (30-40 dB HL).
Regulatory Classification
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.
Predicate Devices
- ER36 Series OAE Test System (K150491)
Submission Summary (Full Text)
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May 11, 2018
Grason-Stadler, Inc. Amy Yanta Director of Regulatory Affairs 10395 West 70th Street Eden Prairie, MN 55344
Re: K180287
Trade/Device Name: GSI Corti Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: February 1, 2018 Received: February 1, 2018
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.
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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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
# 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
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# Indications for Use
510(k) Number (if known) K180287
Device Name GSI Corti
#### Indications for Use (Describe)
The GSI Corti series is indicated for testing of cochlear function in infants, children and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks that are directed into the ear canal. 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 vidence 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.
Type of Use (Select one or both, as applicable)
> 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. The logo features a stylized sound wave graphic in light blue on the left. To the right of the sound wave is the text "gsi" in bold, black font. Below "gsi" is the text "Grason-Stadler" in a smaller, thinner, black font.
#### 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: January 29, 2018
Device Identification
Trade Name: GSI Corti Common Name: audiometer, otoacoustic emission device Device Classification Name: Audiometer Device classification: Class II Panel: Ear Nose & Throat Classification Regulation: 874.1050 Product Code: EWO Predicate Device 1: ER36 Series OAE Test System, cleared on 03/26/2015 via K150491
#### Device Description
Corti test system provides rapid measurement and documentation of Distortion Product Otoacoustic Emissions (DPOAEs) or Transient Evoked Otoacoustic Emissions (TEOAEs) at several frequencies.
The system consists of the instrument, probe, printer, single-use eartips replaceable probe tubes and other accessories. The Corti instrument contains the hardware and software for generating the test stimuli, measuring and displaying the OAEs, and storing the results until they are printed. The plastic housing contains circuit boards that provide the signal processing and display the test results. The instrument also contains a rechargeable lithium-ion battery to power the device. The instrument uses a liquid-crystal display (LCD) and three light-emitting diodes (LEDs) to provide a visual display of test status to the operator. Four push buttons located on the keypad of the device allow the user to control testing and printing, and to reset test protocols.
The Probe houses the speaker and microphone which produce test stimuli and measure the sound pressure level (SPL) present in the sealed ear canal. Interface of the instrument to the ear canal is
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accomplished through disposable eartips, which fit onto the probe tube. The disposable eartips are color coded to facilitate easy selection by size.
Distortion Product Otoacoustic Emissions (DPOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a pair of pure tones at frequencies f1 and f2. The resulting emission of interest is the distortion product tone at the frequency 2f1-f2.
The Corti instrument generates a series of test tones, directs them into the ear canal, and then measures the level of the DPOAE tone generated by the cochlea. By using different test frequencies, the Corti device provides an estimate of outer hair cell function over a wide range of frequencies.
Transient Evoked Otoacoustic Emissions (TEOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a series of wideband clicks.
The Corti instrument generates a series of clicks, directs them into the ear canal, and then analyzes the spectrum of the returning signal, separating the noise and emission. By using band pass filters, the Corti device provides an estimate of outer hair cell function over a wide range of frequencies
## Device Intended Use
The GSI Corti is a test instrument that measures otoacoustic emissions in infants, children, and adults.
The GSI Corti series is indicated for testing of cochlear function in infants, children and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks that are directed into the ear canal.
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.
## Technological Characteristics
A comparison between the subject and predicate device shows that the technological characteristics and indications for use are equivalent. The device employs similar technology to accomplish the same tasks as the predicate. A detailed table is provided below.
| Description | ER36 Series OAE Test System<br>(K150491) | GSI Corti | Equivalency | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------------|
| Type | Audiometer | Audiometer | same | |
| Regulation<br>Number | 21 CFR 874.1050<br>(otoacoustic emission device) | 21 CFR 874.1050<br>(otoacoustic emission device) | same | |
| Classification<br>Product Code | EWO | EWO | Grason-Stadler | |
| Regulatory Class | Class II | Class II | same | |
| Indications for Use | The ER36 is a test instrument<br>that measures otoacoustic<br>emissions in infants, children,<br>and adults. | The GSI Corti is a test instrument<br>that measures otoacoustic<br>emissions in infants, children,<br>and adults. | same | |
| | The ER36 series is indicated for<br>testing of cochlear function in<br>infants, children and adults by<br>measuring otoacoustic emissions<br>(OAEs). The OAEs are generated<br>by a series of clicks that are<br>directed into the ear canal. | The GSI Corti series is indicated<br>for testing of cochlear function<br>in infants, children and adults by<br>measuring otoacoustic<br>emissions (OAEs). The OAEs are<br>generated by a series of clicks<br>that are directed into the ear<br>canal. | same | |
| | Otoacoustic emissions are low<br>level audio frequency sounds<br>that are produced by the cochlea<br>as part of the normal-hearing<br>process. Available evidence<br>suggests that otoacoustic<br>emissions are generated by the<br>cochlea's outer hair cells and that<br>the presence of OAEs is an<br>indication that the outer hair<br>cells are viable. Clinical evidence<br>indicates that these emissions<br>normally occur with normal<br>hearing, or at most, mild hearing<br>loss (usually 30-40 dB HL). The<br>majority of hearing-impaired<br>individuals will be identified by a<br>simple OAE test. | Otoacoustic emissions are low<br>level audio frequency sounds<br>that are produced by the<br>cochlea as part of the normal-<br>hearing process. Available<br>evidence suggests that<br>otoacoustic emissions are<br>generated by the cochlea's outer<br>hair cells and that the presence<br>of OAEs is an indication that the<br>outer hair cells are viable.<br>Clinical evidence indicates that<br>these emissions normally occur<br>with normal hearing, or at most,<br>mild hearing loss (usually 30-40<br>dB HL). The majority of hearing-<br>impaired individuals will be<br>identified by a simple OAE test. | same | |
| | Target<br>Population | Infants, children, and adults | Infants, children, and adults | same |
| | OAE Specifications | | | |
| | OAE<br>Measurement<br>Type | Distortion-Product OAE<br>Transient-Evoked OAE | Distortion-Product OAE<br>Transient-Evoked OAE | same |
| | | DPOAE<br>Frequency<br>Range | 1.0 kHz to 12kHz | 1.0 kHz to 12kHz |
| | DPOAE Stimulus<br>Level | 40 to 65 dB SPL | 40 to 65 dB SPL | same |
| | DPOAE<br>Automatic<br>Pass/Fail Test | Yes | Yes | same |
| | DPOAE<br>Calibration | In-Ear self-calibration | In-Ear self-calibration | same |
| | DPOAE f1/f2<br>Frequency Ratio | 1.22 | 1.22 | same |
| DPOAE Analysis<br>Bands | 4 to 6 bands available | 4 to 6 bands available | same | |
| TEOAE<br>Frequency<br>Range | 500 Hz to 4000 Hz | 500 Hz to 4000 Hz | same | |
| TEOAE Stimulus<br>Level | Adjustable, 70 to 85 dB SPL | Adjustable, 70 to 85 dB SPL | same | |
| TEOAE<br>Automatic<br>Pass/Fail Test | Yes | Yes | same | |
| TEOAE<br>Calibration | In-Ear self-calibration | In-Ear self-calibration | same | |
| TEOAE Analysis<br>Bands | 6 | 6 | same | |
| Instrument Characteristics and Specifications | | | | |
| Instrument Type | Handheld | Handheld | same | |
| Hand held<br>Housing Shape | 2.5in x 6in | 7 in. x 2.75 in x 1.25 in | Larger device<br>for better<br>handle by user | |
| Handheld<br>Housing<br>Material | PC-ABS | PC+ABS CX7240 | Same (material<br>name more<br>specific) | |
| Housing of Ear<br>Probe | Machined Aluminum | Machined Aluminum | same | |
| User Controls | 4 button directional keyboard | 4 button directional keyboard | same | |
| 4 Button<br>Navigation<br>Switch | Surface mount tactile switches | Surface mount tactile switches | same | |
| Cable-Probe<br>Connector | Proprietary durable polarized<br>connector | Proprietary durable polarized<br>connector | same | |
| Test Records<br>Stored in<br>Internal<br>Memory | Up to 250 tests | Up to 250 tests | same | |
| Memory Type | Flash EEPROM | Flash EEPROM | same | |
| Power Supply | Rechargeable Lithium-Ion<br>Battery. Not accessible by user. | Rechargeable Lithium-Ion<br>Battery. Not accessible by user. | same | |
| Maximum | 90 dB SPL | 90 dB SPL | same | |
| Test Probe<br>Types | Cabled probe | Cabled probe | same | |
| User Indicators | Monochrome or Color Character-<br>based LCD display; 4 LED<br>indicators | OLED Display | Provides a<br>sharper image<br>for user | |
| Connection to<br>Computer | USB interface | USB A to micro-B interface | Same (More<br>specific<br>description of<br>USB) | |
| Printer | Bluetooth wireless connection to<br>AC or battery-powered thermal<br>printer | Bluetooth wireless connection<br>to AC or battery-powered<br>thermal printer | same | |
| Test<br>Performance | AAMIANSIS3.6:2010<br>Specifications for Audiometers<br><br>IEC 60645-1:2012:<br>Electroacoustics - Audiometric<br>Equipment - Part 1: Pure-Tone<br>Audiometers<br><br>IEC 60645-3:2007:<br>Electroacoustics - Audiometric<br>Equipment - Part 3: Test Signals<br>of Short Duration, Second Edition<br><br>IEC 60645-6:2009:<br>Electroacoustics - Audiometric<br>Equipment - Part 6: Instruments<br>for the Measurement of<br>Otoacoustic Emissions, First<br>Edition 2009-04 | AAMIANSIS3.6:2010<br><br>IEC 60645-1:2012<br><br>IEC 60645-3:2007<br><br>IEC 60645-6:2009 | same | |
| Operational and<br>Safety | AAMIANSI 60601-1:2005(R):<br>2012: Medical Electrical<br>Equipment, Part 1:General<br>Requirements for Safety, Third<br>Edition<br><br>AAM IANSI IEC<br>62366:2007:(R)2013:Medical<br>Devices - Application of Usability<br>Engineering to Medical Devices,<br>Second Edition 2007-03-01<br><br>ISO 14971:2007: Medical Devices,<br>Application of Risk Management<br>to Medical Devices, Second<br>Edition 2007-03-01 | IEC 60601-1:2005+A1:2012(E)<br><br>ANSI/AAMI 60601-1:2005/(R)<br>2012<br><br>AAMI/ANSI/IEC 62366:2015<br><br>ISO 14971:2007<br><br>UL Registered, File E486032 | Same | |
## Equivalence Predicate Chart 1:
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Image /page/5/Picture/1 description: The image shows the logo for Grason-Stadler. The logo features a blue sound wave graphic on the left, followed by the letters "gsi" in bold, black font. Below "gsi" is the text "Grason-Stadler" in a smaller font size.
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Image /page/6/Picture/1 description: The image shows the logo for Grason-Stadler (GSI). The logo features a stylized sound wave graphic in light blue, followed by the letters "gsi" in bold, black font. Below "gsi" is the text "Grason-Stadler" in a smaller, black font.
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Image /page/7/Picture/1 description: The image shows the logo for Grason-Stadler. The logo features a stylized sound wave graphic in light blue on the left. To the right of the sound wave is the text "gsi" in bold, black font, with "Grason-Stadler" in a smaller font size underneath.
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Image /page/8/Picture/1 description: The image shows the logo for Grason-Stadler, a company that specializes in audiology equipment. The logo features the letters "gsi" in a bold, sans-serif font, with the "g" stylized to include sound waves emanating from it. Below the letters is the name "Grason-Stadler" in a smaller font. The logo is simple and modern, and the use of sound waves in the "g" suggests the company's focus on audiology.
# UL Registered, File E359876
## Summary of Non-Clinical Testing
Design verification and validation were performed according to current standards for OAE 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 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 failure in the device may result in unacceptable loud stimuli which might affect the hearing of the patient. Additionally, a malfunction in the device may delay the proper diagnostic of the hearing problem in patients. The detailed information about the validation and verification of PASS/REFER for the OAE is provided in the GSI Corti Manual, e.g., PASS/REFER Criteria, Sensitivity and Specificity etc. Based on the fulfillment of the international standards for OAE, we believe the device is safe and effective. The auditory impedance testing characteristics and safety systems were compared and found to be comparable.
#### Summary of Clinical Testing
The clinical validation was performed to determine substantial equivalence in the performance of the brand name GSI Corti to the ERO-SCAN. These instruments were used to perform Distortion-Product Otoacoustic Emissions (DPOAE) and Transient-Evoked Otoacoustic Emissions (TEOAE). The individual test results were evaluated for overall test result and signal-to-noise ratio at each frequency. The entire data set was evaluated for emission level, signal-to-noise ratio, as well as the noise floor. The diagnostic performance of the device was evaluated on a selection of test subjects. A population of approximately 80% normal hearing was targeted for the study population, with the remaining approximately 20% having a range of impairment from complete impairment (cavity) to mild hearing impairment. For each subject, the following tests were performed. These tests were performed in an alternating sequence, as arbitrarily determined by the clinical investigator. Each set of tests were performed in their entirety at each of the scheduled test times, on each of the two days.
DPOAE: 4 Frequency (2.0 kHz to 5.0 kHz(default DP screening protocol)) – 65/55 dB SPL Primaries – 4 Second Averaging Time
DPOAE: 6 Frequency (1.5 kHz to 6 kHz(default DP diagnostic protocol)) – 65/55 dB SPL Primaries – 4 Second Averaging Time
TEOAE: 6 Frequency (700 Hz to 4 kHz (default diagnostic TE protocol)) – 83 dB SPL Click Stimulus – 64 Second Maximum Time
TEOAE: 6 Frequency (1.5 kHz to 4 kHz (default TE screening protocol)) – 83 dB SPL Click Stimulus – 64 Second Maximum Time
The results were analyzed to determine if the device provided equivalent diagnostic results on the subject ears as another equivalent device. The results of the validation are considered evidence, when
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## 510(k) Number: K180287 GSI Corti
Image /page/9/Picture/1 description: The image shows the logo for Grason-Stadler, also known as GSI. The logo features a stylized blue sound wave graphic on the left, followed by the letters "gsi" in bold, black font. Below "gsi" is the text "Grason-Stadler" in a smaller font size.
combined with the verification testing, of the ability of the device to meet the requirements associated with the indications for use.
Based on the data and rationales in the clinical validation report it is concluded that for the indication for diagnose and evaluation of hearing;
- The devices demonstrates conformity with the essential principles
- Performance and safety claims have been met and documented
- All risks regarding indications for use and clinical data have been identified, addressed and evaluated
- . Risks associated with the use of the devices are acceptable and weighted
# Conclusion
We have compared the intended use and performance characteristics with the predicate device. The Corti was tested according to current standards and the differences found between the devices were related to minor differences of functionality, not in relation to safety and efficiency. The differences found between the devices were related to minor differences of functionality such as the Corti has a different splash screen on the device and user has option to recharge the batteries utilizing the device cradle in addition to using the charging cable. The Corti conforms to the current standards. After analyzing bench testing, safety, EMC, and software validation (with risk analysis) testing we conclude that the Corti is found to be substantially equivalent to the predicate device in technological characteristics and indications for use.
