(29 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on sound generation and fitting by a healthcare professional.
Yes
The explicit intended use is to "relieve patients suffering from tinnitus" within a "Tinnitus Management Program," indicating a medical therapeutic purpose.
No
Explanation: The device is described as a "Tinnitus Sound Generator Module" that generates sounds to relieve tinnitus. Its purpose is to provide relief, not to diagnose a condition. The text emphasizes its use in a "Tinnitus Management Program" and for "treating patients," further indicating a therapeutic rather than diagnostic function.
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 product.
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 Tinnitus Sound Generator Module is described as a tool to generate sounds for tinnitus management. It is embedded in a hearing instrument and worn by the patient.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the patient. The device's function is to produce sound, not to analyze bodily fluids or tissues.
Therefore, the device's intended use and mechanism of action do not align with the definition of an In Vitro Diagnostic. It is a therapeutic device used to manage a condition through sound generation.
N/A
Intended Use / Indications for 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 primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
The Tinnitus Sound Generator Module is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound Generator Module must be done by a hearing professional participating in a Tinnitus Management Program.
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 all day in all environments. The fitting of the digital device, which contains the Tinnitus Sound Generator Module, is performed by a healthcare professional, in order to meet the exact needs of the tinnitus patient.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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.
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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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. 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.
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
K110932
i
II. 510(K) SUMMARY MAY - 3 2011 510(k) SUMMARY FDA CDRH DMC Submission Type: Special 510(k) APR 1 2011 Submitter: GN ReSound A/S Lars Hagander Received Lautrupbjerg 7 DK-2750 Ballerup Denmark Phone: +45 45 75 11 11 1 April 2011 Date Prepared: Tinnitus Sound Generator Module Device Name: 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: K073636
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 all day in all environments. The fitting of the digital device, which contains the Tinnitus Sound Generator Module, is performed by a healthcare professional, in order to meet the exact needs of the tinnitus patient.
Predicate Device
Tinnitus Sound Generator Module by GN ReSound A/S K073636
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 primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
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Technological Characteristics Comparison
Modifications to the cleared device - including Maximum Power Output, Color of Sound, White Noise Generator, Hearing Aid Software Technique, PC Interface Technique, Amplitude Modulation, and Microphone Muting of Mixing - are not substantial and do not change the operating principle of the TSG Module. The intended use and fundamental technological characteristics remain the same as the predicate device, and modifications do not affect the safety or effectiveness of the device.
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 carc 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.
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Image /page/2/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 symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
GN ReSound A/S C/O Lars Hagander Vice President, Corporate Quality Lautrupbierg 7 DK-2750 Ballerup Denmark
MAY - 3 2011
Re: K110932
Trade/Device Name: Tinnitus Sound Generator (TSG) Module Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: March 30, 2011 Received: April 4, 2011
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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Page 2 - Mr. Lars Hagander
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Melvin R. Eadeh
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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I. INDICATIONS FOR USE STATEMENT
Indications for Use Statement
510(k) Number (if known):
Device Name: TSG Module
Indications for 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 primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
The Tinnitus Sound Generator Module is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound Generator Module must be done by a hearing professional participating in a Tinnitus Management Program.
Prescription Use X (Per 21 C.F.R. 801.109) A:ND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S. Chen-Ping
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110932