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.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Audifon jump C TRT tinnitus masker and related models. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove device effectiveness or meeting specific performance acceptance criteria through studies.

Therefore, much of the requested information about acceptance criteria, clinical study details, and performance metrics is not available in the provided document. The document primarily focuses on comparing the new device's features and intended use to a predicate device.

Here's what can be extracted and what is not available based on the input:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not applicable (No specific performance acceptance criteria are described for this 510(k) submission focusing on substantial equivalence).	RMS Output Characteristics:White noise: 66 dB SPLFrequency range: 200 - 6600 HzVolume Control Range: 23 dB

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No clinical test set data is provided.
Data Provenance: Not applicable. The submission relies on comparison to a predicate device and engineering specifications, not clinical data from a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set or ground truth establishment by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a physical tinnitus masker, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is an analog noise generator, not an algorithm. Its operation is standalone in the sense that it generates noise independently, but it is intended for human use as part of a tinnitus management program.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The submission is a 510(k) based on substantial equivalence, which primarily relies on comparing technical specifications and intended use to a predicate device. There is no mention of a ground truth in the context of clinical outcomes or expert consensus for efficacy. The "Quality Assurance" mentions "Measurements following ANSI 3.22-2003 to ensure proper functioning," which refers to technical performance standards rather than clinical ground truth.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth for it is mentioned.

Summary

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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 perrone@audifon-usa.com 386.668.8812

12. Description of Device

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 InstrumentsTranquil Tri OE
Intended Use	For use in tinnitus retraining therapy andalso suitable for masking tinnitus as part oftinnitus management program	Mask tinnitus as part of tinnitus managementprogram
Indications For Use	Tinnitus patients without a hearing loss
Target Population	Adults with tinnitus that are participating in atinnitus management program	Adults with tinnitus that are participating in atinnitus management program
Operation /Mechanism	Uses broadband noise; Manages tinnitusthrough masking and distractionCircuit type: AnalogProgrammable: NoAvailable noises: OneVolume control: Yesadjustable low-cut filterVolume Control Range: 23 dB	Circuit type: AnalogProgrammable: NoAvailable noises: OneVolume control: YesVolume Control Range: 40 dB
Where Used	May be used anywhere
PhysicalDescription	Standard housing for cymba application	Custom in-the-ear product
Maximum OutputCharacteristics	RMS Output Characteristics:White noise: 66 dB SPLfrequency range: 200 - 6600 Hz	RMS Output Characteristics:High-tone noise: 75 dB SPL
Power Source	Uses standard 10A zinc air 1.4V hearing aidbattery
Quality Assurance	Measurements following ANSI 3.22-2003 toensure 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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(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 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

Regulation Number and Section

§ 874.3400 Tinnitus masker.

(a)
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.(b)
Classification. Class II. 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.