SMARTTROAE

K023859 · Intelligent Hearing Systems · EWO · Jan 8, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K023859
• Device Name: SMARTTROAE
• Applicant: Intelligent Hearing Systems
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jan 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

Device Story

SmartTrOAE measures transient and spontaneous otoacoustic emissions to assess cochlear function. Device uses a probe inserted into the patient's outer ear canal to deliver sound stimuli (click or tone) and record resulting emissions. System consists of an external electronic box connected to a personal computer via USB. Operated by trained personnel in hospitals, nurseries, or clinics. Output includes stimulus level, response level, noise level, and signal-to-noise ratio, presented as frequency spectra and analysis windows. Data allows clinicians to evaluate inner ear health without requiring subjective patient responses.

Clinical Evidence

Bench testing only. Performance data compared SmartTrOAE against the predicate device across key parameters including stimulus duration (25-5000 µsec), intensity (60-90 dB SPL), repetition rate (1-50 Hz), and analysis window (2.5-22.5 msec). No clinical study data provided.

Technological Characteristics

External electronic box connected to PC via USB. Stimulus delivery and sensing via Etymotic Research ER 10B or ER 10D probes. Stimulus types: click or tone. Intensity: 60-90 dB SPL. Analysis parameters: 500-5000 Hz frequency range, 2.5-22.5 msec post-stimulus window. User-selectable rejection thresholds and sweep counts (1-260).

Indications for Use

Indicated for patients requiring objective assessment of cochlear function via otoacoustic emissions testing. No specific age or gender restrictions; intended for use by trained personnel in clinical or nursery settings.

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

• Otodynamics ILO88 (K962995)

Reference Devices

• Etymotic Research ER 10B (K930553)
• Etymotic Research ER 10D (K011114)

Submission Summary (Full Text)

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K023859

Image /page/0/Picture/1 description: The image shows the logo for Intelligent Hearing Systems. The words "Intelligent Hearing" are in large, bold, black letters. Below that, the word "Systems" is spelled out with each letter in a black square with white text.

JAN 0 8 2003

## 510(k) Summary

| Prepared By: | Intelligent Hearing Systems<br>7356 SW 48th Street<br>Miami, FL 33155 | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Telephone: | [phone] | |
| FAX: | [phone] | |
| Contact Person: | Edward Miskiel | |
| Date Summary prepared: | December 17, 2002 | |
| Name of the Device: | SmartTrOAE | |
| Common Name: | Otoacoustic Emissions Test Instrument | |
| Classification Name: | Audiometer (per CFR 874.1050) | |
| Predicate Device: | Otodynamics ILO88 (K962995) | |
| Device Description: | SmartTrOAE is an otoacoustic emissions testing device that is<br>capable of measuring transient and spontaneous otoacoustic<br>emissions produced by the inner ear. | |
| Intended Use: | The intended use of the SmartTrOAE device is to measure<br>otoacoustic emissions, which allow the operator to get<br>information on cochlear function without requiring a subjective<br>response from the person being tested with the device. It is<br>intended to be used by trained personnel in a hospital, nursery,<br>clinic, audiologist's office or other appropriate setting. | |
| Technological Characteristics: | The SmartTrOAE device is similar to the predicate device in its<br>intended use and methodologies.<br>The SmartTrOAE device technologically differs from the<br>predicate device in that the electronic circuitry of SmartTrOAE<br>device is housed in an external box that is connected to personal<br>computer by a USB cable connection, whereas the electronic<br>circuitry of the predicate device is housed internally to the<br>computer and is connected to the computer by an interface bus. | |

## INTELLIGENT HEARING SYSTEMS

7356 S.W. 48th Street

• Miami, Florida 33155 • • Telephone: [phone] • FAX: [phone]
Email Address: [e-mail] • www.ihsys.com Email Address: [e-mail] • www.ihsys.com

K: 305-668-6103
Page E1

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## Substantial Equivalence Based on Assessment of Performance Data:

The SmartTrOAE is substantially equivalent to the ILO88 device marketed by Otodynamics Ltd. with FDA 510(k) clearance number K890124.

| Parameter | Predicate Device<br>(Non-Preamendmant Device)<br>ILO88<br>(K890124) | Device Under Current 510(k)<br>Review<br>SmartTrOAE | |
|---------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Stimulus | | | |
| Type | Click | Click or Tone | |
| Duration | 100 µsec | 25 - 5000 µsec | |
| Intensity | 90 dB SPL | 60 - 90 dB SPL | |
| Repetition Rate | 50 Hz | 1 - 50 Hz | |
| Microphone | Otodynamics | Etymotic Research ER 10B<br>(K930553) or<br>Etymotic Research ER 10D<br>(K011114) | |
| Measured Values | Stimulus Level (dB SPL)<br>Response Level (dB SPL)<br>Noise Level (dB SPL)<br>Signal to Noise Ratio (dB SPL) | Stimulus Level (dB SPL)<br>Response Level (dB SPL)<br>Noise Level (dB SPL)<br>Signal to Noise Ratio (dB SPL) | |
| Measurement<br>Parameters | Bandlimit Filter<br>Analysis Window<br>Freq. Spectrum | 500 - 5000 Hz<br>2.5 to 20 msec post stimulus<br>0 - 6000 Hz | 500 - 5000 Hz<br>2.5 - 22.5 msec post stimulus<br>0 - 6000 Hz |
| Analysis Parameters | Sweeps<br>Rejection Threshold | 1 - 260<br>User Selectable | 1 - 260<br>User Selectable |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2003

Intelligent Hearing Systems c/o Edward Miskiel, Ph.D. 7356 SW 48th Street Miami, FL 33155

Re: K023859

Trade/Device Name: Otoacoustic Emissions Test Instrument / SmarTrOAE Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: November 19, 2002 Received: November 20, 2002

Dear Dr. Miskiel:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); good manufacturing practice requirements as set

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Page 2 - Edward Miskiel, Ph.D.

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

J. Joseph Rosenthal

A. Ralph Rosenthal. 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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510(k) Number (if known): K023859

Device Name: SmartTrOAE

Indications For Use:

The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

The anatomical site of contact is the patient's outer ear canal(s) with the contact object being a probe that is capable of measuring and delivering sound.

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Prescription Use
(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation

Jams K. Kane, Ph.D.
Division Sign-Off

Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K023859