(86 days)
Not Found
No
The device description explicitly states it is an "analog noise generator" with "variable output level and an adjustable low-cut filter," indicating traditional signal processing rather than AI/ML. The "Mentions AI, DNN, or ML" section is also marked as "Not Found."
Yes
The device is intended for "masking timitus as part of tinnitus management program" and is used in "tinnitus retraining therapy," indicating a therapeutic purpose to alleviate symptoms.
No
Explanation: The device is described as an "analog noise generator" used for "masking tinnitus" as part of a "tinnitus management program." Its function is to generate broadband noise, not to diagnose a condition.
No
The device description explicitly states it is an "analog noise generator" housed in a "standard housing for cymba application," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The jump C TRT is a noise generator applied to the ear to manage tinnitus. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is to generate noise for tinnitus management, not to diagnose or detect a condition through the analysis of biological samples.
Therefore, the jump C TRT falls outside the scope of an In Vitro Diagnostic device. It is a therapeutic device used for symptom management.
N/A
Intended Use / Indications for Use
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.
Product codes
KLW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
adult population
Intended User / Care Setting
licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
1
| | audifon jump C TRT | General Hearing Instruments
Tranquil Tri OE |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in tinnitus retraining therapy and
also suitable for masking tinnitus as part of
tinnitus management program | Mask tinnitus as part of tinnitus management
program |
| Indications For Use | Tinnitus patients without a hearing loss | |
| Target Population | Adults with tinnitus that are participating in a
tinnitus management program | Adults with tinnitus that are participating in a
tinnitus management program |
| Operation /
Mechanism | Uses broadband noise; Manages tinnitus
through masking and distraction
Circuit type: Analog
Programmable: No
Available noises: One
Volume control: Yes
adjustable low-cut filter
Volume Control Range: 23 dB | Circuit type: Analog
Programmable: No
Available noises: One
Volume control: Yes
Volume Control Range: 40 dB |
| Where Used | May be used anywhere | |
| Physical
Description | Standard housing for cymba application | Custom in-the-ear product |
| Maximum Output
Characteristics | RMS Output Characteristics:
White noise: 66 dB SPL
frequency range: 200 - 6600 Hz | RMS Output Characteristics:
High-tone noise: 75 dB SPL |
| Power Source | Uses standard 10A zinc air 1.4V hearing aid
battery | |
| Quality Assurance | Measurements following ANSI 3.22-2003 to
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
2
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.
3
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.
4
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
5
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
6
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
7
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
8
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