OTOGRAM, CA3350

K070118 · Tympany, Inc. · EWO · Mar 7, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K070118
• Device Name: OTOGRAM, CA3350
• Applicant: Tympany, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Mar 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Otogram is an auditory diagnostic instrument intended to administer, under supervision by a trained healthcare professional, a battery of diagnostic and screening procedures that include the following: 1) Pure tone air and bone conduction audiometry with automated masking 2) Speech recognition threshold with automated masking 3) Speech discrimination with automated masking 4) Tympanometry 5) Acoustic reflex threshold, both ipsilateral and contralateral 6) Distortion product otoacoustic emissions 7) Pure tone Stenger 8) Patient survey The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders.

Device Story

Otogram CA3350 is a computer-controlled diagnostic instrument combining audiometry, distortion product otoacoustic emissions (DPOAE) analysis, and tympanometry. The device connects to a PC via RS-232 port; control software on the PC manages the instrument. It performs pure tone air/bone conduction audiometry, speech recognition/discrimination, tympanometry, acoustic reflex thresholds, DPOAE, and Stenger tests. Operated by trained healthcare professionals in clinical settings, the device provides diagnostic data to assist in identifying hearing loss and ear disorders. The clinician reviews the output to inform clinical decision-making. Benefits include a comprehensive, integrated diagnostic battery for efficient patient assessment.

Clinical Evidence

Bench and user testing performed. Comparison testing conducted by a Hearing Instrument Specialist Intern to validate performance against predicate devices. No clinical trial data provided.

Technological Characteristics

Computer-controlled audiometric instrument. Interfaces via RS-232. Electrical safety per IEC 60601-1, 60601-1-1, and 60601-1-2 (EMC). Performance/calibration per IEC 1027, ANSI S3.39, and IEC 60645-5. Class II device.

Indications for Use

Indicated for adult and pediatric patients to measure audiometric parameters for the identification and diagnosis of hearing loss and ear disorders. Used by trained healthcare professionals.

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

• Impedance Audiometer Madsen Zodiac 901 (K910247)
• Otoacoustic Emissions Bio-Logic AuDX (K974076)
• Tympany Otogram Combined Device (K041853)

Submission Summary (Full Text)

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### 510(k) Supplementary Information K070118

1. Submitters Name and Address: Tympany, Inc.

| | 2795 East Cottonwood Parkway, Suite 660<br>Salt Lake City, UT 84121<br>Phone: [phone]<br>FAX: [phone] |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person & Phone: | Mr. Lex J. Pearce<br>Phone: [phone]<br>FAX: [phone]<br>[e-mail] |
| 3. Date Prepared: | 26 January 2007 |
| 4. Device Name / Classification: | Audiometer, Otoacoustic Emissions Analyzer (21<br>CFR 874.1050, Product Code EWO)<br>Auditory Impedance Tester, Tympanometer (21<br>CFR 874.1090, Product Codes ETY, NAS) |
| 5. Proprietary / Trade Name: | Otogram CA3350 |

#### 6. Device Description:

The Otogram CA3350 is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer). The device is controlled through the use of ASCII commands transmitted over a standard RS-232 communication port. Control software is installed on the supplied PC.

#### 7. Intended Use:

The Otogram is an auditory diagnostic instrument intended to administer, under supervision by a trained healthcare professional, a battery of diagnostic and screening procedures that include the following:

1) Pure tone air and bone conduction audiometry with automated masking

- 2) Speech recognition threshold with automated masking
- 3) Speech discrimination with automated masking

4) Tympanometry

- 5) Acoustic reflex threshold, both ipsilateral and contralateral
- 6) Distortion product otoacoustic emissions
- 7) Pure tone Stenger
- 8) Patient survey

The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders.

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| | The previous version of this chart appears in Exhibits 5, 10, and 12. | | | | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Characteristic | Predicate<br>Impedance Audiometer<br>Madsen Zodiac 901<br>K910247 | Predicate<br>Otoacoustic Emissions<br>Bio-Logic AuDX<br>K974076 | Predicate<br>Tympany Otogram<br>Combined Device<br>Impedance Audiometer<br>Otoacoustic Emissions<br>K041853 | Predicate<br>Tympany Otogram<br>CA3350<br>Combined Device<br>Impedance Audiometer<br>Otoacoustic Emissions<br>K070118 |
| | Intended Use: | To diagnose a variety of<br>middle ear disorders using<br>impedance and static<br>pressure measurements<br>(i.e., tympanometry and<br>acoustic reflex) in the ear<br>canal. | To test cochlear function<br>by measuring otoacoustic<br>emissions. | To diagnose hearing and<br>otologic disorders in the<br>middle-ear and total ear<br>system, using audiometry,<br>Tympanometry, and<br>acoustic reflex. To test<br>cochlear function and<br>presence of otoacoustic<br>emissions. | To administer, under<br>supervision by a trained<br>healthcare professional, a<br>battery of diagnostic and<br>screening procedures that<br>include pure tone air and<br>bone conduction<br>audiometry with automated<br>masking, speech<br>recognition threshold with<br>automated masking, speech<br>discrimination with<br>automated masking,<br>tympanometry, acoustic<br>reflex threshold (both<br>ipsilateral and<br>contralateral), distortion<br>product emissions, pure<br>tone Stenger and patient<br>survey. |
| Characteristic | Predicate<br>Impedance Audiometer<br>Madsen Zodiac 901<br>K910247 | Predicate<br>Otoacoustic Emissions<br>Bio-Logic AuDX<br>K974076 | Predicate<br>Tympany Otogram<br>Combined Device<br>Impedance Audiometer<br>Otoacoustic Emissions<br>K041853 | Tympany Otogram<br>CA3350<br>Combined Device<br>Impedance Audiometer<br>Otoacoustic Emissions<br>K070118 | |
| Physical<br>characteristics: | | | | | |
| Computer<br>interface: | RS 232C | RS 232C | Computer included, RS<br>232C | Computer included, RS<br>232C | |
| Internal printer | Thermal 112 mm, 4.5" | Thermal 59 mm,<br>2 1/4" | Thermal 58 mm,<br>2 1/4" | NA | |
| Printer interface | Parallel port | RS 232C thermal printer | Parallel port or USB<br>Computer LCD 1024 x 768 | Parallel port or USB<br>Computer LCD 1024 x 768 | |
| Display | Graphic supertwist LCD<br>backlight, 256 lines x 128<br>dots<br>White text/graphics on<br>blue background | LCD 1" x 3"<br>Black and white | Color, resistive<br>touchscreen | Color, resistive<br>touchscreen | |
| Control interface | Keyboard | Touchpad | Keyboard, touchscreen | Keyboard, touchscreen | |
| Size/weight-<br>metric | 370 x 385 x 120 mm<br>(W x D x H), 7.6 kg | 98 x 41 x 197 mm<br>(W x D x H), 0.45 kg | 410 x 300 x 480 mm<br>(W x D x H), 20.4 kg | 356 x 348 x 493 mm<br>(W x D x H), 21.1 kg | |
| Size/weight-<br>American | 14.8" x 15.4" x 4.8", 16.8<br>lbs | 3 7/8" x 1 5/8" x 7 3/4", 1<br>lb | 16" x 19", x 12", 45 lbs | 14.0" x 13.7" x 19.4", 46.5<br>lbs | |
| Energy source | AC 50/60 Hz, 100-240 V | AC 50/60 Hz, 100-240 V | AC 50/60 Hz, 100-120 V | AC 47-63 Hz. 90-250<br>VAC | |
| Hardcopy output | Thermal paper or external<br>printer paper | External thermal printer | Thermal paper or external<br>printer paper | External printer paper | |
| Standard and<br>safety<br>characteristics: | | | | | |
| Performance and<br>calibration | IEC 1027, ANSI S3.39 | NA | IEC 1027, ANSI S3.39 | IEC 1027, ANSI S3.39,<br>IEC 60645-5 | |
| Electrical safety | EN 60601-1, class I,<br>type B | EN 55011: 1991 group 1<br>Class B | EN 60601-1, class I,<br>type B | IEC 60601-1 and 60601-1-<br>1, class I, type B and BF<br>and IEC 60601-1-2 (EMC) | |

rs in Ev 8. Updated Substantial Equivalence Chart:
The previous version of this chart appea

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and the comments of the comments of

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# 9. Significant changes from predicate Tympany Otogram combination device:

- Expansion of intended use to include use by "trained healthcare professional" vs. "qualified/trained audiologist"
- The indications for use stated in the 501(k) submission for the Bio-Logic AuDX device (K974076) indicates use by a "trained health care professional (for example an Audiologist)"
- Training for the Otogram CA3350 includes a thorough review and training using the User Instruction Guide included in Exhibit 13 of the 510(k) submission.
- Comparison testing with predicate devices was performed by a Hearing Instrument Specialist Intern - someone who has been trained on the use of the equipment, but is not an audiologist. Test reports are contained in Exhibit 12 of the 510(k) submission.
- Different computer and improved design on various components and assemblies.
- Computer specifications and design specifications are contained in Exhibit 11 of the 510(k) submission.

# 10. Safety and Effectiveness comparison to predicate devices:

The results of bench, user, and laboratory testing indicate that the new device is as safe and effective as the predicate devices.

# 11. Conclusion:

After analyzing both bench and user testing data, it is the conclusion of Tympany Inc. that the Tympany Otogram CA3350 is safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Image /page/4/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 an abstract symbol that resembles an eagle or bird-like figure.

MAR 0 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tympany, Inc. c/o Lex J. Pearce 2795 East Cottonwood Parkway, Suite 660 Salt Lake City, UT 84121

Re: K070118

Trade/Device Name: Otogram CA3350 Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, NAS, ETY Dated: January 11, 2007 Received: January 12, 2007

Dear Mr. Pearce:

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. Iisting 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 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.

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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]. 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 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/cdrb/industry/support/index.html.

Sincerely yours,

M.B. Egelman Si MD

g

Malvina B. Evdelman. 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): K070118

Device Name: Otogram CA3350

Indications for Use:

The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer) The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders.

The Otogram is an auditory diagnostic instrument intended to administer, under supervision by a trained healthcare professional, a battery of diagnostic and screening procedures that include the following:

1) Pure tone air and bone conduction audiometry with automated masking

2) Speech recognition threshold with automated masking

3) Speech discrimination with automated masking

4) Tympanometry

5) Acoustic reflex threshold, both ipsilateral and contralateral

6) Distortion product otoacoustic emissions

7) Pure tone Stenger

8) Patient survey

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ___________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------------------|--|
| Division of Ophthalmic Ear, Nose and Throat Devises | |

| 510(k) Number | K070118 |
|---------------|---------|
|---------------|---------|

| | Prescription Use<br>(Per 21 CFR 801.109) |
|--|------------------------------------------|
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