JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT

K083488 · Audifon-USA, Inc. · KLW · Feb 19, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K083488
• Device Name: JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
• Applicant: Audifon-USA, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Feb 19, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The jump C TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.

Device Story

The jump C TRT is an analog noise generator for tinnitus retraining therapy. It generates broadband noise (200-6600 Hz) to mask tinnitus symptoms. The device is worn in the ear (cymba application) and is powered by a 10A zinc-air battery. It features a variable output level (23 dB range) and an adjustable low-cut filter for custom noise shaping. The device is fitted by a licensed hearing healthcare professional (audiologist, hearing aid specialist, or otolaryngologist). It does not provide amplification. By providing broadband noise, the device assists in tinnitus masking and distraction, potentially providing relief when used alongside counseling and habituation therapy.

Clinical Evidence

Bench testing only. Performance verified via measurements following ANSI 3.22-2003 to ensure proper functioning and output characteristics (66 dB SPL white noise). No clinical data provided.

Technological Characteristics

Analog noise generator; non-amplifying. Powered by 10A zinc-air 1.4V battery. Features adjustable low-cut filter and volume control (23 dB range). Frequency range 200-6600 Hz. Output 66 dB SPL. Form factor: standard housing for cymba application. Quality assurance per ANSI 3.22-2003.

Indications for Use

Indicated for adults with chronic persistent tinnitus who do not require hearing amplification and are participating in a tinnitus management program.

Regulatory Classification

Identification

A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.

Special Controls

The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care, (2) Risks, (3) Benefits, (4) Warnings for safe use, and (5) Specifications.

Predicate Devices

• General Hearing Instruments Tranquil Tri OE (K974751)

Submission Summary (Full Text)

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## 5. 510(k) Summary

FEB 1 9 2009

1083488

#### Indications for Use 11.

November 14, 2008

Contact Information:

Jane E Perrone Vice President of U.S. Operations Audifon USA Inc. 403 Chairman Ct., Suite 1 Debary, FL 32713 Jane [e-mail] 386.668.8812

The jump C TRT is addressed to the adult population with a chronological persistent ringing in the ears (Timitus), who do not need or desire amplification. It may be used for masking timitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.

#### 12. Description of Device

The jump C TRT is an analog noise generator that was developed to be used in a tinnitus retraining therapy. This product has a variable output level and an adjustable low-cut filter for a custom-tailored noise shape, which fits the individual user. It is housed in a standard housing for cymba application.

#### 13. Comparison Information to Predicate Device

The jump C TRT is substantially equivalent to the General Hearing Instruments Tranquil Tri OE (K974751). Both products are analog noisier with no amplification. The jump C TRT differs in the housing for cymba application and in an additional adjustable low-cut filter, so the product can be individualized for every user. A detailed comparison is given in the following table.

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| | audifon jump C TRT | General Hearing Instruments<br>Tranquil Tri OE |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in tinnitus retraining therapy and<br>also suitable for masking tinnitus as part of<br>tinnitus management program | Mask tinnitus as part of tinnitus management<br>program |
| Indications For Use | Tinnitus patients without a hearing loss | |
| Target Population | Adults with tinnitus that are participating in a<br>tinnitus management program | Adults with tinnitus that are participating in a<br>tinnitus management program |
| Operation /<br>Mechanism | Uses broadband noise; Manages tinnitus<br>through masking and distraction<br>Circuit type: Analog<br>Programmable: No<br>Available noises: One<br>Volume control: Yes<br>adjustable low-cut filter<br>Volume Control Range: 23 dB | Circuit type: Analog<br>Programmable: No<br>Available noises: One<br>Volume control: Yes<br>Volume Control Range: 40 dB |
| Where Used | May be used anywhere | |
| Physical<br>Description | Standard housing for cymba application | Custom in-the-ear product |
| Maximum Output<br>Characteristics | RMS Output Characteristics:<br>White noise: 66 dB SPL<br>frequency range: 200 - 6600 Hz | RMS Output Characteristics:<br>High-tone noise: 75 dB SPL |
| Power Source | Uses standard 10A zinc air 1.4V hearing aid<br>battery | |
| Quality Assurance | Measurements following ANSI 3.22-2003 to<br>ensure proper functioning | |

#### Information required under Title 21, Section 8743400, and not already provided 14. above

## Risks to health

There is no more risk associated with the use of this device than the use of a conventional hearing aid or tinnitus masker, because the device cannot deliver damaging sound

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intensity. (OSHA Regulations (Standard - 29 CFR 1910.95 Occupational Noise Exposure))

## Hearing Healthcare Professional Diagnosis

The sale and fitting of the jump C TRT will only be conducted through a Hearing Healthcare Professional, such as an audiologist, hearing aid specialist or otolaryngologist.

## Benefits

Relief of timitus symptoms may be provided by the jump C TRT when utilized with appropriate counselling and tinnitus habituation or masking therapy.

## Warnings for Save Use

As this device cannot deliver damaging sound intensity, there is no warning required about sound output level. General use precautions are given in the User's manual.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features an eagle with its wings spread, symbolizing the federal government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Audifon Hearing Systems c/o Jane E. Perrone, Vice President of U.S. Operations 403 Chairman CT., Suite 1 Debary, FL 32713

FEB 1 9 2009

### Re: K083488

Trade/Device Name: jump S TRT, jump S+ TRT, jump CIC TRT, jump C TRT Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: II Product Code: KLW Dated: January 12, 2009 Received: January 14, 2009

### Dear Ms. Perrone:

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 slass II gifting the class III (PNIA) it and 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 - Jane E. Perrone

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

M. B. Egolman, mD

Malvina B. Eydelman, 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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023488

## 4. Indications for Use Statement

510(k) Number (if known). K083488

Device Name: audifon jump S TRT

Indications for Use:

The jump S TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking timitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband soise with sufficere coandwidth and intensity and is applied on the car.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <div style="text-align:center;">AND/OR</div> | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|----------------------------------------------|------------------------------------------------|
|-------------------------------------------------|----------------------------------------------|------------------------------------------------|

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

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

Oman K. Ram, PhD

Page 1 of 1

vision Sign-O ision of Ophthalmic and Ear,

510(k) Number RO

Number K083482

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Ko83488

# 4. Indications for Use Statement

510(k) Number (if known): K083488

audifon jump CIC TRT Device Name:

Indications for Use:

The jump CIC TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist Therefore it generates a broadband noise with sefficient bandwidth and intensity and is applied on the ear.

es reption Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

James K. Kam, Ph.D.

Page 1 of 1

hthalmic and Ear,

510(k) Num

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# 16083480

## 4. Indications for Use Statement

510(k) Number (if known): K083488

Device Name: audifon jump C TRT

Indications for Use:

The jump C TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking timitus as part of timitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with suffic nt bandwidth and intensity and is applied on the ear.

Prescription Use (Par 2) CFR 807 Sul . as D)

ANDKIR

Over-The Counter Use ( i . TR 80 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jones R. Kane Ph.D

Page 1 of 1

Division Sign-Off)
Division of Ophthalmic and Ear,
Nose and Throat Devices

510(k) Number K083488

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K6234YY

# 4. Indications for Use Statement

510(k) Number (if known): K083488

Device Name: audifon jump S+ TRT

Indications for Use:

The jump S+ TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking timitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband nover with a ffirst of bandwidth and intensity and is applied on the ear.

I rescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

ice Evaluation (ODE)

Page 1 of 1

(Division Sign-Off) ivision of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K083488