(108 days)
No
The document describes a sound generator and control app for tinnitus relief, with no mention of AI, ML, or related concepts. The focus is on sound generation and user control within limits set by a healthcare professional.
Yes
The device is described as "a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from Tinnitus," directly implying a therapeutic purpose.
No
The device is described as a "tool to generate sounds" for "Tinnitus Management Program to relieve patients suffering from Tinnitus," indicating a therapeutic rather than diagnostic function. It helps manage symptoms, not diagnose the condition.
No
The device description explicitly states that the software solution is "embedded into a digital hearing instrument platform," indicating it is part of a hardware device, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Tinnitus Sound Generator Module is a software solution embedded in a hearing instrument that generates sounds to help manage tinnitus. It interacts with the patient's auditory system, not with biological specimens.
- Intended Use: The intended use is to "relieve patients suffering from Tinnitus" as part of a "Tinnitus Management Program." This is a therapeutic or management function, not a diagnostic one based on analyzing biological samples.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Timitus Management Program to relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
Product codes
KLW
Device Description
The Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provides relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device in all environments. The fitting of the digital device, which contains the Timitus Sound Generator module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient.
A mobile medical application (app) is available as an accessory to the Tinnitus Sound Generator. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Control App.
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
primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
Intended User / Care Setting
healthcare professionals, doctor, audiologists, hearing care practitioner
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)
GN ReSound has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements.
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Gn Resound A/s Mr. Lars Hagander Vice President, Corporate Quality Lautrupbjerg 7 Ballerup, DK-2750 DK
Re: K150171
Trade/Device Name: Tinnitus Sound Generator Module Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: January 16, 2015 Received: January 26, 2015
Dear Mr. Hagander:
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.
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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 (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.
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 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 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.
Deborah L. Falls -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
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Indications for Use
510(k) Number (if known) K150171
Device Name Tinnitus Sound Generator Module
Indications for Use (Describe)
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Timitus Management Program to relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| Submission Type: | Special 510(k) |
|---|---|
| Submitter: | GN Resound A/S |
| Lars Hagander | |
| Lautrupbjerg 7 | |
| DK-2750 Ballerup | |
| Denmark | |
| Phone: +45 45 75 11 11 | |
| Registration number: 3005650109 | |
| Date Prepared: | 15 January 2015 |
| Device Name: | Tinnitus Sound Generator Module |
| Device Class: | Class II |
| Classification Name: | 21 CFR 874.3400 Tinnitus masker |
| Classification Panel: | Ophthalmic and Ear, Nose, and Throat Division |
| Product Code: | KLW |
| Predicate Device: | K110932 |
Device Description
The Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provides relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device in all environments. The fitting of the digital device, which contains the Timitus Sound Generator module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient.
A mobile medical application (app) is available as an accessory to the Tinnitus Sound Generator. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Control App.
Predicate Device
Tinnitus Sound Generator Module by GN ReSound A/S K110932
Intended Use
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from Tinnitus. The target population is
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primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
Technological Characteristics Comparison
There are five modifications (synchronization of the amplitude modulated signal, synchronization of environmental monitoring and combined volume control, environmental monitoring program, natural sound selection and enabling communication via a wireless interface to a TSG control app).
The revisions to the Tinnitus Sound Generator module are technological software advancements that improve the functionality of the device, whilst having minimal risk to the patient and are minor modifications in relation to the predicate device that do not change the operating principle of the TSG module.
Performance Data
GN ReSound has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements.
Other - Pediatric Use Precautions
The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older. However, children and physically or mentally challenged users will require training by a doctor, audiologists, hearing care practitioner or the guardian for the insertion and removal of the device containing the TSG module.
Children and physically or mentally challenged users will require guardian supervision while wearing the device.
The volume control is an optional feature in the TSG module used for adjusting the sound generator output level. To prevent unintended usage by pediatric or physically or mentally challenged users, the volume control must, if enabled, be configured to only provide a decrease of the sound generator output level.
Conclusions
Modifications to the device do not raise new or different questions of safety or effectiveness for the device's intended use. The results of risk analysis and design verification and validation activities provide evidence that the device is as safe and effective as its predicate. This therefore demonstrates that the TSG module is substantially equivalent to its predicate device.