(174 days)
Not Found
No
The description focuses on a digital noise generator with programmable settings adjusted by a hearing care professional, with no mention of AI or ML capabilities.
Yes.
The device is intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol to provide temporary relief for tinnitus symptoms, which qualifies it as a therapeutic device.
No
The device is described as a "digital noise generator" intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol to provide temporary relief for tinnitus symptoms. It does not perform any diagnostic function such as evaluating or identifying a medical condition.
No
The device description explicitly states it is "housed in a standard In-the-ear instrument housing, in a standard behind-the-ear instrument housing as well as in standard receiver-in-the ear housing," indicating it is a physical device with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The audifon Tinnitus-Module is a sound generator designed to be used as part of a therapy protocol for tinnitus. It generates sound to provide temporary relief from tinnitus symptoms.
- Lack of Specimen Examination: The device does not examine any specimens from the human body (like blood, tissue, etc.). Its function is to produce sound, not to analyze biological samples.
- Therapeutic Purpose: The intended use is for temporary relief of symptoms through sound therapy, which is a therapeutic intervention, not a diagnostic one.
Therefore, the audifon Tinnitus-Module falls outside the definition of an In Vitro Diagnostic device. It is a therapeutic device used in the management of a medical condition.
N/A
Intended Use / Indications for Use
audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing timitus symptoms. The module in a hearing aid.
audifon Tinnitus-Module is intended for adults over 18 years of age.
audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Timitus-Module must be done by a hearing care professional participating in a tinnitus management program.
Product codes (comma separated list FDA assigned to the subject device)
KLW
Device Description
The above mentioned audifon Tinnitus module is a digital noise generator which was developed to be used in a tinnitus retraining therapy. This product has up to four different programs, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifon audifit software. Within the software the amplification of the device can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It can be housed in a standard In-the-ear instrument housing, in a standard behind-the-ear instrument housing as well as in standard receiver-in-the ear housing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults over 18 years of age.
Intended User / Care Setting
licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Timitus-Module must be done by a hearing care professional participating in a tinnitus management program.
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)
The non-clinical performance data which were measured according to official standards (ANSI S3.22-2014) verify that the devices have a similar effectiveness as the predicate device. For TRT therapy sound level below 80 dB SPL are needed. Level above 80 dB SPL usually not used. Furthermore. as described within the OSHA (29CFR 1910.95) the output level should not exceed 85 dB A. Therefore a warning in the software will occur that higher level should not be used or only in case of a hearing loss. So the lower maximum output has no influence on the effectiveness of the devices.
The frequency range provides an equivalent white noise with the same sound quality.
In conclusion, the non-clinical tests demonstrate that the submitted devices are as safe as effective the predicate device and the performance are as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
October 19, 2017
audiofon USA, Inc. Jane E. Perrone V.P. of U.S. Operations 403 Chairman CT., Suite 1 Debary, FL 32713
Re: K171243
Trade/Device Name: audifon Tinnitus-Module Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: September 13, 2017 Received: September 18, 2017
Dear Jane E. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Srinivas Nandkumar -S
for 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
2
Indications for Use
510(k) Number (if known) K171243
Device Name audifon Tinnitus-Module
Indications for Use (Describe)
audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing timitus symptoms. The module in a hearing aid.
audifon Tinnitus-Module is intended for adults over 18 years of age.
audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Timitus-Module must be done by a hearing care professional participating in a tinnitus management program.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/2 description: The image shows the logo for Audifon hearing systems. The word "audifon" is written in gray letters, except for the "o" which is red. Below the word "audifon" is the phrase "hearing systems" in a smaller, gray font.
l. Introduction
| 1. | Applicant's Name and Address: | audifon USA Inc.
403 Chairman Ct., Suite 1
Debary, Florida 32713
PO BOX 531700
USA |
|-----|----------------------------------------------|------------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Jane E Perrone
Phone: 386-6688812 |
| 3. | Trade or Proprietary Name: | audifon Tinnitus-Module |
| 4. | Device Common Name /
Classification Name: | Tinnitus Masker
(Regulation Number: 21 CFR 874.3400) |
| 5. | Product Code: | KLW |
| 6. | Classification of Device: | Class II |
| 7. | Type of 510(k) submission | Abbreviated 510(k) |
| 8. | Establishment Registration
Number: | 3005384855 |
| 9. | Address of Manufacturing Site: | audifon GmbH& Co. KG
Werner-von-Siemens-Str. 2
D-99625 Kölleda
Germany |
| 10. | Predicate Device Identification: | K130514
audifon vico TRT devices |
| 11. | Date of Preparation | April 02, 2017 |
4
Image /page/4/Picture/2 description: The image shows the logo for Audifon hearing systems. The word "audifon" is written in gray letters, with the "o" in "audifon" being red. Below the word "audifon" is the phrase "hearing systems" in a smaller, gray font.
Indications for Use .
audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module can be embedded in a hearing aid.
audifon Tinnitus-Module is intended for adults over 18 years of age.
audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Tinnitus-Module must be done by a hearing care professional participating in a tinnitus management program.
. Description of Device
The above mentioned audifon Tinnitus module is a digital noise generator which was developed to be used in a tinnitus retraining therapy. This product has up to four different programs, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifon audifit software. Within the software the amplification of the device can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It can be housed in a standard In-the-ear instrument housing, in a standard behind-the-ear instrument housing as well as in standard receiver-in-the ear housing.
IV. Comparison Information to Predicate Device
The mentioned devices are substantially equivalent to the audifon vico TRT devices (K130514). The mentioned devices and the audifon vico TRT devices are fully digital masker, with programmable noises. Within the program the level and the shape of the noise can be adjusted. Also the mentioned devices and the audifon vico TRT devices provide an additional amplification and can be programmed with the fitting software and a standard HI-PRO programming box.
The non-clinical performance data which were measured according to official standards (ANSI S3.22-2014) verify that the devices have a similar effectiveness as the predicate device. For TRT therapy sound level below 80 dB SPL are needed. Level above 80 dB SPL usually not used. Furthermore. as described within the OSHA (29CFR 1910.95) the output level should not exceed 85 dB A. Therefore a warning in the software will occur that higher level should not be used or only in case of a hearing loss. So the lower maximum output has no influence on the effectiveness of the devices.
The frequency range provides an equivalent white noise with the same sound quality.
In conclusion, the non-clinical tests demonstrate that the submitted devices are as safe as effective the predicate device and the performance are as well as the predicate device.
The submission for tinnitus masker relies on a special control that is defined in section 874.3400. The special controls are identical applied as with the predicate device and supports the substantial equivalence.
5
The following tables compare the submitted devices and the audifon vico TRT devices.
| | audifon device with active audifon
Tinnitus-Module | audifon vicoTRT family |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | audifon Tinnitus- Module is a tool
intended to generate sound as part of
a Tinnitus Retraining Therapy (TRT)
protocol designed to provide
temporary relief for people
experiencing tinnitus symptoms. The
module can be embedded in a hearing
aid.
audifon Tinnitus- Module is intended
for adults over 18 years of age.
audifon Tinnitus- Module is targeted
for licensed hearing care professionals
who are familiar with the evaluation
and treatment of tinnitus and hearing
losses. The fitting of audifon Tinnitus-
Module must be done by a hearing
care professional participating in a
tinnitus management program. | The combined devices are intended
for persons suffering from a chronic
persistent ringing in the ears (Tinnitus)
in combination with a mild to moderate
hearing loss that is indicated for a
hearing aid fitting. The products may
be used for masking Tinnitus as part
of a Tinnitus Retraining Therapy (TRT)
protocol and should be utilized only in
consultation with a qualified hearing
healthcare professional. The devices
provide hearing aid amplification to
compensate for the hearing loss as
well as broadband noise for immediate
distraction or masking of Tinnitus or
long term habituation of Tinnitus. |
| Operation /
Mechanism | Uses broadband noise; Manages
tinnitus through masking and
distraction
Digital
Circuit type:
Programmable:
Yes
Available noises:
Four
Volume control:
Yes
white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones | Uses broadband noise; Manages
tinnitus through masking and
distraction
Digital
Circuit type:
Programmable:
Yes
Available noises:
Four
Volume control:
Yes
white-noise is adjustable
noise level is programmable
adjustable Low Battery Indicator
programmable Program Switch Tones |
| Where Used | May be used anywhere | May be used anywhere |
| Physical
Description | Standard In-the-ear instrument
housing
Standard behind-the-ear instrument
housing
Standard receiver-in-the-ear
instrument housing | Standard In-the-ear instrument
housing
Standard behind-the-ear instrument
housing |
| | audifon device with active audifon
Tinnitus-Module | audifon vicoTRT family |
| Maximum
Output
Characteristics | White noise: 100 - 112 dB SPL
frequency range:100 - 8000 Hz | White noise: 107 - 116 dB SPL
frequency range: 100 - 8000 Hz |
| Power Source | standard 10 zinc air 1,4V hearing aid
battery
standard 312 zinc air 1,4V hearing aid
battery
standard 13 zinc air 1,4V hearing aid
battery | standard 10 zinc air 1,4V hearing aid
battery
standard 312 zinc air 1,4V hearing aid
battery
standard 13 zinc air 1,4V hearing aid
battery |
| Quality
Assurance
Standard | ANSIS3.22-2014 to ensure proper
functioning of HA | ANSIS3.22-2014 to ensure proper
functioning of HA |
6
Image /page/6/Picture/2 description: The image shows the Audifon hearing systems logo. The word "audifon" is written in gray letters, except for the "o" which is red. Below the word "audifon" is the phrase "hearing systems" in smaller gray letters.
Conclusion V.
- The devices have similar operating mechanisms as the predicate device. ●
- . The devices have similar acoustic characteristics as the predicate device.
- The devices are similar in style as the predicate device. .
- The devices are similar in intended use as the predicate device .
- The devices have the same targeted population as the predicate device