GSI 70 AUDIOPATH SCREENER

K974237 · Grason-Stadler, Inc. · EWO · Feb 10, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K974237
• Device Name: GSI 70 AUDIOPATH SCREENER
• Applicant: Grason-Stadler, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Grason-Stadler Inc. model GSI 70 AudioPath™ Hearing Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults). The instrument has combined a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry within one hand held instrument. The device is intended to be used by trained personnel within a medical or school environment. This device is not intended for use in prescribing or fitting assistive listening devices such as hearing aids, cochlear implants or wireless microphones, or to diagnose the causes of detected hearing losses.

Device Story

Handheld screening device; integrates Otoacoustic Emission (OAE) screening, tympanometry, and pure tone audiometry. Inputs: patient response via switch (audiometry), microphone response (tympanometry/OAE), and pressure changes (tympanometry). Operation: trained personnel in medical/school settings perform tests; device uses internal DSP to process signals. Outputs: test results displayed on device; data exportable via IRDA to Windows-based software for graphing and patient ID management. Benefits: consolidates three diagnostic functions into one portable unit; enables efficient hearing loss tracking across all ages. Safety: includes watchdog timers for tone generation; pressure-limited pump; battery-powered.

Clinical Evidence

Bench testing only. Device performance verified against established ANSI standards (S3.6 for audiometry, S3.39 for tympanometry) and electrical safety standards (IEC 601-1, UL2601-1). No clinical data provided.

Technological Characteristics

Portable handheld device; rechargeable battery powered. Features miniature probe speakers and microphone. Connectivity: IRDA. Software: Windows-based for data management. Safety: Watchdog timers for tone monitoring; pressure-limited pump. Standards: ANSI S3.6 (audiometry), ANSI S3.39 (tympanometry), IEC 601-1, UL2601-1, CSA 601-1-M90, EN55011, IEC801-2/3/4.

Indications for Use

Indicated for detection and tracking of hearing loss and abnormal middle ear conditions in all patients, from premature infants through adults. Intended for use by trained personnel in medical or school settings. Not for prescribing/fitting assistive listening devices or diagnosing causes of hearing loss.

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

• Grason-Stadler Inc. model GSI 60 DPOAE system (K934658S1)
• GSI 37 Auto Tymp (K911095)
• GSI 17 Screening Audiometer (K902540)

Submission Summary (Full Text)

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### "510(k) SUMMARY" Summary of Safety and Effectiveness

| Submitter's Name & Address: | Grason-Stadler Inc.<br>1 Westchester Drive<br>Milford, N.H. 03055-3056 | | | FEB 10 1998 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-------------|
| Contact Person & Telephone: | Norman L. Schultz<br>[phone] | | | |
| Date Summary Prepared: | September 12, 1997 | | | |
| Device Name: | Classification Name - Audiometer<br>Common/Usual Name - Screening Audiometer<br>Proprietary Name - GSI 70 AudioPath™ Screener | | | |
| Predicate Device: | Grason-Stadler Inc. model GSI 60 DPOAE system (ref. 510(k) #K934658S1) GSI 37 Auto Tymp (ref. 510(k) #K911095 ), and the<br>GSI 17 Screening Audiometer (ref. 510(k) #K902540). | | | |

# Device Description, intended Use & Effectiveness:

The Grason-Stadler Inc. model GSI 70 AudioPath™ Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (From premature infants through adults age). The instrument has a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry. The device is intended to be used by trained personnel in a medical or school environment. This device is not intended for use in prescribing or fitting assisstive listening devices such as hearing aids, cochlea implants or wireless microphones.

### Technological Characteristics:

See attachment "A" for a comparison of the GSI 70 AudioPath™ Screener to the predicate device.

### Safety:

The GSI 70 AudioPath™ Screener is designed to provide electrical safety to the patient as well as the user. The system is designed to meet the following standards related to electrical safety: IEC 601-1, UL2601, and CSA 601-1-M90. To prevent excessive tone levels within the ear the system is designed with watchdog timers that monitor the system and disable the tone generation when disparity is detected. Also, the speakers that are used within the probes are

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incapable of producing enough decibels to permanently damage the ear. The pump for the tympanometry function has been designed such that the volume of the pump is incapable of producing a pressure that would exceed the safe level as specified within ANSI S3.39.

The system will also be certified to the following standards:

| EMI EN55011 | Group 1 Class B requirements (medical equipment, conducted and radiated<br>emissions). |
|-------------|-------------------------------------------------------------------------------------------------|
| IEC801-2 | ESD Susceptibility. |
| IEC801-3 | Radiated Electromagnetic Field Susceptibility. |
| IEC801-4 | Conducted Susceptibility to Line Transients. |
| CE Mark | Conforms with provisions of European Council Directive 93/42/EEC concerning<br>medical devices. |

#### Summary of Effectiveness:

The GSI 70 AudioPath™ Screener is a consolidation of three current audiological products into one portable instrument making it equivalent or better in effectiveness for the detection and tracking of hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults).

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# Attachment A Chart of Predicate Device Comparison

| Technological<br>Specification | GSI 17 | GSI 37 | GSI 60 | GSI 70 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source | Powered by a low<br>voltage DC wall<br>mounted power supply. | Powered by a low<br>voltage DC wall<br>mounted power supply. | Powered by battery or<br>a low voltage DC wall<br>mounted power<br>supply. | Powered by re-<br>chargeable battery. |
| Battery Low<br>Indication. | None | None | LED lights on front of<br>instrument. | Battery low indicator on<br>display. |
| Safety<br>Compliance. | IEC 601-1 and UL544 | IEC 601-1 and UL544 | IEC 601-1 and<br>UL2601-1 | IEC 601-1 and UL2601-<br>1 |
| Computer Interface | RS232 | None | DSP Board plugged<br>into printer interface. | IRDA communications |
| Audiometry | Technology used is<br>speaker headset that<br>present tones to patient<br>which if perceived is<br>indicated by a patient<br>response switch. Tone<br>quality and frequency<br>specified per ANSI S3.6. | N/A | N/A | Tones are presented by<br>a minature speaker<br>within the probe which if<br>perceived is indicated<br>by the patient using a<br>response switch. Tone<br>quality and frequency<br>specified per ANSI S3.6. |
| Tympanometry | N/A | Tones are presented<br>during a pressurization<br>of the ear by a<br>minature pump and<br>response is recorded<br>by a microphone. Tone<br>quality and frequency<br>controlled by ANSI<br>S3.39. | N/A | Same as GSI 37 |
| OAE Probe Design | N/A | N/A | Two speakers and a<br>microphone present<br>and record response<br>from cochlea of ear. | Same as GSI 60 |
| DSP Software for<br>OAE Function | | | GSI 60 DSP Software | Same |
| Supporting software<br>for OAE Function | | | Windows based<br>software that graphs<br>DP result, allows<br>changes to protocall,<br>export of data, and<br>changes to patient ID. | Windows based<br>software that shows<br>result, allows export of<br>data, and updating of<br>patient ID. |

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN..." is arranged in a circular fashion around the left side of the emblem, partially obscured.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1998

Norman L. Schultz Senior Quality Engineer Grason-Stadler, Inc. 1 Westchester Drive Milford, New Hampshire 03055-3056 Re:

K974237 GSI 70 AudioPath TM Hearing Screener Dated: November 7, 1997 Received: November 12, 1997 Regulatory class: II Procode: 77 EWO, 21 CFR 874.1050 77 ETY, 21 CFR 874.1090

Dear Mr. Schultz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the ensement 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). 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Portugions, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Onality System Regulation (OS) for Medical Devices: General regulation (21/CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) and additionally 809.10 for in vity diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and " advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premailed notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): イタフ 4 237

Device Name: GSI 70 AudioPath™ Hearing Screener

# Indications For Use:

The Grason-Stadler Inc. model GSI 70 AudioPath™ Hearing Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults). The instrument has combined a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry within one hand held instrument. The device is intended to be used by trained personnel within a medical or school environment. This device is not intended for use in prescribing or fitting assistive listening devices such as hearing aids, cochlear implants or wireless microphones, or to diagnose the causes of detected hearing losses.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Simpson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)