OTOGRAM

K041853 · Tympany, Inc. · ETW · Sep 3, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K041853
• Device Name: OTOGRAM
• Applicant: Tympany, Inc.
• Product Code: ETW · Ear, Nose, Throat
• Decision Date: Sep 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3310
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Otogram can perform the functions of: 1. Pure tone and speech audiometer. 2. Impedance audiometer (tympanometry, acoustic reflex), and 3. Distortion product otoacoustic emissions analyzer. The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

Device Story

Otogram is a computer-controlled audiometric instrument combining pure tone/speech audiometry, impedance audiometry (tympanometry, acoustic reflex), and distortion product otoacoustic emissions (DPOAE) analysis. Device inputs include acoustic signals for testing; system is controlled via ASCII commands from a PC running proprietary software. Device performs measurements and outputs results to a display or printer. Used in clinical settings by audiologists to diagnose hearing and otologic disorders. System integrates with NOAH v.3 hearing aid fitting software. Benefits include comprehensive diagnostic capability in a single platform, aiding clinical decision-making regarding patient hearing health and cochlear function.

Clinical Evidence

Bench and user testing performed. No clinical trials on human subjects reported. Testing confirmed performance metrics and safety parameters (e.g., pressure range, frequency accuracy) are consistent with predicate devices and relevant standards (IEC 1027, ANSI S3.39).

Technological Characteristics

Combined audiometer, impedance meter, and DPOAE analyzer. Features peristaltic pump (stepper motor controlled), resistive touchscreen, and PC-based control via RS-232. Connectivity: RS-232, USB, parallel port. Standards: IEC 1027, ANSI S3.39, EN 60601-1 (Class I, Type B). Thermal printer output. Multi-language support.

Indications for Use

Indicated for adult and pediatric patients requiring audiometric testing, acoustic impedance measurement (tympanometry, acoustic reflex), and distortion product otoacoustic emissions analysis. Intended for use by qualified/trained audiologists.

Regulatory Classification

Identification

A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Predicate Devices

• Madsen Zodiac (K910247)
• Biologic Audx (K974076)

Submission Summary (Full Text)

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## EXHIBIT 2 Tympany Inc. 12807 Royal Drive, Suite 101 Stafford, TX 77477 Phone [phone] Fax [phone] Toll-Free 866.316.3606 Contact: Kenneth Barrow, Vice President Prepared July 2, 2004 510(k) Summary

- 1. Identification of the Device: Proprietary-Trade Name: Otogram Classification Name: Audiometer 77 EWO. (Otoacoustic emission devices are not exempt) and 77 ETY, Admittance Meter (874.1090 Common/Usual Name: Audiometer, Impedance Audiometer, Otoacoustic Emissions Device
- 2. Equivalent legally marketed devices This product is similar in design and function to the Madsen Zodiac, K910247 and the Biologic Audx, K974076
- 3. Indications for Use (intended use) "Otogram" can perform the functions of:
- 1. Pure tone and speech audiometer.
- 2. Impedance audiometer (tympanometry, acoustic reflex), and
- 3. Distortion product otoacoustic emissions analyzer.

The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

- 4. Description of the Device: The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, a Impedance Instrument, and a DPOAE Instrument. 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. The device performs comprehensive audiometry; tympanometry, acoustic reflex; and otoacoustic emissions. Additional features include manual audiometer and NOAH v.3 compliant (hearing aid fitting software). Available in multiple languages, including English, Spanish, Russian, Mandarin, Vietnamese, and Korean.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench, user, and laboratory testing indicates that the new device is as safe and effective as the predicate device.

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# 6. Substantial Equivalence Chart

| Characteristic | | Predicate<br>Impedance<br>Audiometer<br>Madsen Zodiac 901<br>K910247 | Predicate<br>Otoacoustic<br>Emissions<br>Bio-Logic AuDX<br>K974076 | Tympany Otogram<br>Combined Device<br>Impedance<br>Audiometer<br>Otoacoustic<br>Emissions |
|------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | | To diagnose hearing and<br>otologic disorders in the<br>middle-ear and total ear<br>system, using audiometry,<br>tympanometry, and acoustic<br>reflex. | To test cochlear function<br>and presence of 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 acoustic<br>reflex. To test cochlear<br>function and presence of<br>otoacoustic emissions |
| Technical | | | | |
| characteristics | | | | |
| Probe tone: | | | | |
| | Probe tone<br>frequency | 226 Hz | NA | 226 Hz, +/- 3% |
| | Probe tone level | 85 dB SPL | NA | 70 dB SPL, +/- 3 dB |
| Admittance<br>measurement: | | | | |
| | Total range | 0.1 ml to 8.0 ml | NA | 0.2 ml to 6.0 ml |
| | Reflex range | 0 ul to 375 ul | NA | 0 ul to 375 ul |
| | Calibration | 2 cc cavity | | 0.5, 2, 5 cc cavity |
| Pressure system: | | | | |
| | Pump system | Plunger type; stepper motor,<br>digitally controlled | NA | Peristaltic pump; stepper<br>motor, digitally controlled |
| | Pressure range -<br>normal | +200 to -400 daPa | NA | +200 to -400 daPa |
| | Pressure range -<br>extended | +400 to -600 daPa | NA | NA |
| | Accuracy | +/- 10% or +/- 10 daPa<br>(whichever is greater) | NA | +/- 15% or +/- 10 daPa<br>(whichever is greater) |
| | Pump speed | As fast as possible: | NA | 50 daPa/sec to 150<br>daPa/sec |
| | | 400 daPa/sec, 200<br>daPa/sec, 100 daPa/sec, 50<br>daPa/sec | NA | |
| | | Manuals speed control | NA | NA |
| | Air release | Mechanical safety release<br>valve set to +600 and -800<br>daPa | NA | Mechanical safety release<br>valve set to +600 and -800<br>daPa |
| | | Manual & automatic air<br>release | NA | Manual & automatic air<br>release |
| Ipsi/contralateral<br>stimuli | | | | |
| | Pure tone | 0.5, 1, 2, 4 kHz | NA | 0.5, 1, 2, 4 kHz |
| | Step size | 1, 2, 5, 10 dB | NA | 1 to 10 dB |
| | Attenuator range,<br>ipsi lateral<br>stimulus | 0.5, 1.0, 2.0, kHz 50-115 dB<br>HL, 4.0 kHz 50-90 dB HL | NA | 0.5, 1.0, 2.0, 4.0 kHz 80-105<br>dB HL |
| | Attenuator range,<br>contra lateral<br>stimulus | 0.5, 1.0, 2.0, 4.0 kHz 50-100<br>dB HL, white noise | NA | 0.5, 1.0, 2.0, 4.0 kHz 80-100<br>dB HL |
| | Frequency<br>accuracy | +/- 0.5% | +/- 0.5% | +/-0.5% |
| Distortion Product<br>Otoacoustic<br>Emissions | | | | |
| | Stimulus | | NA | 2 pure tone stimulus |
| Characteristic | | Predicate<br>Impedance<br>Audiometer<br>Madsen Zodiac 901<br>K910247 | Predicate<br>Otoacoustic<br>Emissions<br>Bio-Logic AuDX<br>K974076 | Tympany Otogram<br>Combined Device<br>Impedance<br>Audiometer<br>Otoacoustic<br>Emissions |
| | | | channels | channels |
| | F2 test frequency | NA | 2.0, 3.0, 4.0, 5.0 kHz | 1.0, 1.5, 2.0, 3.0, 4.0 kHz |
| | Stimulus level<br>range | NA | 55 dB SPL and 65 dB SPL | 45-70 dB SPL |
| Physical<br>characteristics: | | | | |
| | Computer<br>interface | RS 232C | RS 232C | Computer included, RS<br>232C |
| | Internal printer | Thermal 112 mm, 4.5" | Thermal 59 mm, 2 1/4" | Thermal 58 mm, 2 1/4" |
| | Printer interface | Parallel port | RS 232C thermal printer | Parallel port or USB |
| | Display | Graphic supertwist LCD<br>backlight, 256 lines x 128<br>dots | LCD 1" x 3" | Computer LCD 1024 x 768 |
| | | White text/graphics on blue<br>background | Black and white | Color, resistive touchscreen |
| | Control interface | Keyboard | Touchpad | Keyboard, touchscreen |
| | Size/weight -<br>metric | 370 x 385 x 120 mm (W x D<br>x H), 7.6kg | 98 x 41 x 197 mm (W x D x<br>H), 0.45 kg | 410 x 300 x 480 mm (W x D<br>x H), 20.4 kg |
| | Size/weight -<br>American | 14.8" x 15.4" x 4.8", 16.8 lbs | 3 7/8" x 1 5/8" x 7 3/4", 1 lbs | 16" x 19" x 12", 45 lbs |
| | Energy source | AC 50/60 Hz, 100-240 V | AC 50/60 Hz, 100-240 V | AC 50/60 Hz, 100-120 V |
| | Hardcopy output | Thermal paper or external<br>printer paper | External thermal printer | Thermal paper or external<br>printer paper |
| Standard and safety<br>characteristics | | | | |
| | Performance and<br>calibration | IEC 1027, ANSI S3.39 | NA | IEC 1027, ANSI S3.39 |
| | Electrical safety | EN 60601-1, class I, type B | EN 55011: 1991 Group 1<br>Class B | EN 60601-1, class I, type B |

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#### 7. Conclusion

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

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract human figures, represented by curved lines, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2004

Tympany, Inc. c/o Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K041853

Trade/Device Name: Otogram, Audiometer, Impedance Audiometer, and Otoacoustics Emissions Device Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: ETY; ETW Dated: July 6, 2004

Received: July 9, 2004

Dear Mr. Kamm:

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 I hat 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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### Page 2 - Daniel Kamm, P.E.

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/cdrh/dsma/dsmamain.html

Sincerely yours,

A kalgi korenthal

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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# Indications for Use

510(k) Number (if known):

K041853

Device Name: "Otogram" Combination -(Pure tone and speech audiometer, impedance audiometer, and distortion product otoacoustic emissions analyzer.)

Indications For Use:

"Otogram" can perform the functions of:

- Pure tone and speech audiometer, 1.
- Impedance audiometer (tympanometry, acoustic reflex), and 2.
- Distortion product otoacoustic emissions analyzer. 3.

The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

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)

Prescription Use
(Per 21 CFR 801.109) TVC 8/30/04

TYC 8/30/04

Jivision of Onl Nose and Throat

510(k) Number K041853

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