BIO-LOGIC INSERT EARPHONES

K031352 · Bio-Logic Systems Corp. · EWO · Jul 16, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K031352
• Device Name: BIO-LOGIC INSERT EARPHONES
• Applicant: Bio-Logic Systems Corp.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jul 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

Device Story

Bio-logic Insert Earphones are passive transducers for auditory evoked response systems (e.g., ABaer, Navigator Pro). Device receives electrical stimulus from the stimulator via a shielded cable and 6-pin Mini DIN connector; internal passive analog filters provide pre-emphasis response shaping. Speakers convert electrical signals into acoustic stimuli, delivered to the patient's ear canal via silicon tubing and disposable foam eartips. Used in clinical settings by healthcare professionals to facilitate auditory testing. Output is acoustic sound pressure; clinical benefit is the delivery of controlled auditory stimuli for diagnostic assessment of hearing. The device is non-sterile and contains no moving parts or thermal-producing components.

Clinical Evidence

Bench testing only. Sound level output measured in a Bruel & Kjaer Type 711 Occluded Ear simulator comparing the subject device and the predicate. Results showed the Bio-logic Insert Earphone output was 3 dB lower than the predicate (resolved via calibration) and the Broadband version provided a wider frequency response.

Technological Characteristics

Passive transducer system; shielded cable; 6-pin Mini DIN connector; passive analog filter for frequency shaping; silicon tubing; disposable foam eartips. Frequency bandwidth: 100 Hz – 4,000 Hz (standard) or 100 Hz – 10,000 Hz (broadband). Non-sterile. No active electronics or thermal components.

Indications for Use

Indicated for infants, children, and adults undergoing auditory evoked response testing to deliver auditory stimuli.

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

• Etymotic Research ER-3 Insert Earphones (K930003)

Submission Summary (Full Text)

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K031352

Image /page/0/Picture/2 description: The image shows a logo for Bio-Logic Systems Corp. The logo consists of a black square with a white circle partially overlapping the lower-left corner. The text "Bio-Logic" is written in white letters below the circle, with the word "SYSTEMS CORP" in smaller letters underneath. The registered trademark symbol is located to the right of the word "logic".

One Bio-logic Plaza Mundelein, IL 60060-3700 1-800-323-8326 Fax: [phone] www.bio-logic.com

# Section 10:

# Premarket Notification 510(k) Summary

## Date of which the Summary was Prepared:

April 25, 2003

| Submitted By: | Bio-logic Systems Corp.<br>One Bio-logic Plaza<br>Mundelein, IL 60060 |
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| Telephone: | 847-949-5200 ext. 359 |
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| Fax: | 847-949-8615 |
| Email: | [e-mail] |
| Contact Person: | Erik Gundersen |
| Name of Device: | Bio-logic Insert Earphones |
| Common Name: | Earphones for Evoked Response auditory stimulus delivery |
| Classification Name: | Accessories to devices with classification:<br>Stimulator, Auditory, Evoked Response,<br>(per 21 CFR section 882.1900) |
| Predicate Device: | Etymotic Research ER-3 Insert Earphones, 510(k)<br>#K930003 |

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#### Description of the Device:

The Bio-logic Insert Earphones are transducers that convert electrical stimulus, provided by the Bio-logic ABaer / Navigator Pro Auditory Evoked Response Stimulators, into acoustic stimulus, which is then coupled to the patient's ears. They are comprised of five sections: 1.) Electrical Transmission Path, 2.) Electrical Filter, 3.) Speaker, 4.) Acoustic Transmission Path, and 5.) Transducer Case.

The Electrical Transmission Path consists of a shielded cable. The cable is connected to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response Stimulators, by means of a 6-pin Mini DIN. The other end of the cable is connected to the left and right Electrical Filter Sections.

Each Electrical Filter section (left and right) consists of a passive analog filter to provide electrical pre-emphasis response shaping to the stimulus prior to reaching the Speakers.

Each Speaker (left and right) converts the electrical stimulus into an acoustic stimulus. The acoustic stimulus is delivered to the patient's ear by means of the Acoustic Transmission Path.

Each Acoustic Transmission Path (left and right) consists of silicon tubing and a tube nipple. The tube nipple provides acoustic and mechanical connection to a disposable eartip. The disposable eartips interface to the patient's ear and deliver the acoustic stimulus.

Each Transducer Case (left and right) houses an Electrical Filter and Speaker and provides means of handling and labeling.

### Intended Use of the Device:

The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

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| Parameter for<br>Comparison | Etymotic<br>Research ER-3<br>Insert Earphones<br>(510(k) #K930003) | Bio-logic<br>Insert Earphone | Bio-logic<br>Broadband Insert<br>Earphone |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Auditory Evoked<br>Response | Same | Same |
| Target Population | Infants, Children,<br>and Adults | Same | Same |
| Human Factors | Simple, easy-to-<br>follow instructions<br>are provided. | Same | Same |
| Design | Transducer and<br>circuit mounted in a<br>case. Connected to<br>the test device via a<br>cable, and<br>connected to the<br>patient via silicon<br>sound tube and<br>foam eartip. | Similar physical<br>design with<br>different cable type<br>and slightly<br>different acoustics. | Similar physical<br>design with<br>different cable type,<br>transducer type,<br>acoustics and filter<br>to produce a<br>broader band<br>frequency response<br>at a lower output. |
| 1 kHz Sensitivity<br>(re IEC 711<br>Coupler @ 1.0<br>Vrms AC Drive) | 114 dB SPL | 111 dB SPL | 85 dB SPL |
| Frequency<br>Bandwidth (± 5<br>dB)(re IEC 711<br>Coupler) | 100 Hz – 4,000 Hz | Same | 100 Hz – 10,000<br>Hz |
| Energy Used and<br>or Delivered | Device is passive<br>and consumes less<br>than 0.5 Wpeak.<br>This electrical<br>energy is converted<br>into acoustic<br>energy and<br>delivered to the<br>patient's ear. | Same | Same |
| Standards Met | Associated with<br>stimulation device | Same | Same |
| Bio-compatibility | All material passed<br>bio-compatibity<br>testing | Same | Same |
| Sterility | Not supplied sterile | Same | Same |
| Parameter for<br>Comparison | Etymotic<br>Research ER-3<br>Insert Earphones<br>(510(k) #K930003) | Bio-logic<br>Insert Earphone | Bio-logic<br>Broadband Insert<br>Earphone |
| Compatibility<br>with Environment | No environmental<br>issues | Same | Same |
| Chemical Safety | No chemicals<br>involved in the use<br>of this device. | Same | Same |
| Thermal Safety | Device does not<br>contain any thermal<br>producing<br>components. | Same | Same |
| Mechanical Safety | Device does not<br>contain any moving<br>components. | Same | Same |
| Electrical Safety | Patient is isolated<br>from device via<br>silicon sound tube<br>and foam eartip. | Same | Same |

# Comparison Summary of Technological Characteristics:

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### Discussion and Assessment of Non-Clinical Performance Data:

Non-clinical testing was performed to demonstrate the substantial equivalence of the Biologic Insert Earphones to the Etymotic Research ER-3 Insert Earphones. This performance testing consisted of measuring the sound level within a Bruel & Kjaer Type 711 Occluded Ear simulator using a Bio-logic Navigator Pro Auditory Evoked Response Stimulator with the Etymotic Research ER-3 Insert Earphone, the Bio-logic Insert Earphone, and the Bio-logic Broadband Insert Earphone.

The test results show that the sound level output of the Bio-logic Insert Earphone is an average of 3 dB lower than the Etymotic ER-3 Insert Earphone. This difference in output is calibrated by increasing the drive signal by +3 dB. After the calibration, the resulting frequency response is nearly

The test results show that the sound level output of the Bio-logic Broadband Insert Earphone is an average of 29 dB lower than the Etymotic ER-3 Insert Earphone. This difference is due to the fact that Bio-logic Broadband Insert Earphone was designed to have a much smoother, wider bandwidth frequency response. The Bio-logic Broadband Insert Earphones are a special version of the Bio-logic Insert Earphones and are utilized ONLY for applications where wider bandwidth is required.

Therefore, it is concluded that the performance of the Bio-logic Insert Earphones is very similar to that of the Etymotic ER-3 Insert Earphone (510(k) #K930003), and they are therefore substantially equivalent to this predicate device.

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles an eagle or bird with three stripes extending from its back.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 16 2003

Bio-Logic Systems Corporation c/o Erik C. Gundersen Design Engineer IV One Bio-logic Plaza Mundelein, IL 60060

Re: K031352

Trade/Device Name: Bio-logic Insert Earphones Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: April 25, 2003 Received: April 30, 2003

Dear Mr. Gundersen:

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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Page 2 – Erik C. Gundersen

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 Kalpi 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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## Section 8:

### Statement for Indications for Use

510(k) Number (if known):_K (03/352

Device Name: Bio-logic Insert Earphones

Indication For Use:

The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div> ✓ </div> | OR | Over-The-Counter Use | |
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| Prescription Use<br>(Per 21 CFR 801.109) | <div> ✓ </div> | <div> (Division Sign-Off)<br/> Division of Ophthalmic Ear,<br/> Nose and Throat Devises </div> | (Optional Format 1-2-96) |
|------------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| 510(k) Number | K031352 | | |