(77 days)
Not Found
No
The summary describes a digital noise generator and hearing aid with programmable settings, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is intended for Tinnitus Retraining Therapy and is used to manage chronic persistent ringing in the ears, which falls under therapeutic use.
No
The device description and intended use indicate that the device is a digital noise generator and hearing aid used for tinnitus management and amplification, not for diagnosing a condition. Its function is to generate noise and provide amplification, which are therapeutic and assistive functions, respectively.
No
The device description explicitly states it is "housed in a standard receiver-in-the-ear instrument housing," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a hearing aid and noise generator applied to the ear. It directly interacts with the patient's auditory system and does not analyze any biological specimens.
- Its intended use is for managing tinnitus and providing amplification for hearing loss. This is a therapeutic and assistive function, not an in vitro diagnostic one.
The description clearly indicates it's a device for auditory therapy and assistance, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The switch 8 TRT is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a mild to a moderate hearing loss. 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 sufficient bandwidth and intensity and is applied on the ear.
Product codes (comma separated list FDA assigned to the subject device)
ESD, KLW
Device Description
The switch 8 TRT is a digital noise generator and hearing aid that was developed to be used in a tinnitus retraining therapy. This product has four different programs, which can be programmed in shape and level to fit the individual users' needs. The programming can be done with a standard HI-PRO and the audifit software. Within the software the amplification of the combi-masker can be fitted to the individual needs. The noise can be adjusted in shape with lowcut and high-cut filters and in the output level. It is housed in a standard receiver-in-the-ear instrument housing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
on the ear
Indicated Patient Age Range
Adults
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): 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.
K003558 Siemens TCI Combi
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
510(k) Summary
AUG 12 2009
K091552
AUG 1
- Applicant's Name and Address:
audifon USA Inc. 403 Chairman Ct., Suite 1 Debary, Florida 32713 PO BOX 531700 USA
-
Contact Person: Jane E Perrone Phone: 386-668-8812
-
Trade or Proprietary Name:
-
Device Common Name / Classification Name
Product Code 5.
ESD, KLW
switch 8 TRT
Classification of Device 6.
Establishment Registration Number 7.
Address of Manufacturing Site 8.
Class I for hearing aid Class II for tinnitus masker
Hearing Aid, Tinnitus Masker
3005384855
audifon GmbH & Co.KG Werner-von-Siemens-Str. 2 D-99625 Kölleda Germany
Market Device with 9. Substantial Equivalence K003558 Siemens TCI Combi
1
Description of Device
audifon switch 8 TRT Device Name:
The switch 8 TRT is a digital noise generator and hearing aid that was developed to be used in a tinnitus retraining therapy. This product has four different programs, which can be programmed in shape and level to fit the individual users' needs. The programming can be done with a standard HI-PRO and the audifit software. Within the software the amplification of the combi-masker can be fitted to the individual needs. The noise can be adjusted in shape with lowcut and high-cut filters and in the output level. It is housed in a standard receiver-in-the-ear instrument housing.
Indications for Use:
The switch 8 TRT is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a mild to a moderate hearing loss. 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 sufficient bandwidth and intensity and is applied on the ear.
Comparison Information to Predicate Device
The switch 8 TRT is substantially equivalent to the Siemens TCI Combi (K003558). Both devices are fully digital nosier, with four programmable noises. Within the programs the level and the shape of the noise can be adjusted. Also both devices provide an additional amplification and can be programmed with fitting software and a standard Hi-Pro programming box.
| switch 8 TRT | Siemens TCI Combi | |
|---|---|---|
| Intended Use | Mask tinnitus as part of tinnitus management | |
| program | Mask tinnitus as part of tinnitus management | |
| program | ||
| Indications For | ||
| Use | chronological persistent ringing in the ears, | |
| Tinnitus patients with or without a hearing | ||
| loss | Tinnitus patients with or without a hearing loss | |
| Target | ||
| Population | Adults with tinnitus that are participating in a | |
| tinnitus management program | Adults and children (≥ 5 years) with tinnitus | |
| that are participating in a tinnitus management | ||
| program |
2
| Operation /
Mechanism | Uses broadband noise; Manages tinnitus
through masking and distraction
Circuit type: Digital
Programmable: Yes
Available noises: Four
Volume control: No
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
Circuit type: Digital
Programmable: Yes
Available noises: Four
Volume control: Yes
Volume Control Range:
Programmable: OFF, 8 dB, 16 dB, 32 dB |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Where Used | May be used anywhere | May be used anywhere |
| Physical
Description | Standard receiver-in-the-ear instrument
housing | Standard behind-the-ear instrument housing |
| Maximum
Output
Characteristics | RMS Output Characteristics:
White noise: 100 dB SPL
(maximum output fixed at 80dB)
frequency range: 200 - 6000 Hz | RMS Output Characteristics:
White noise: 102 dB SPL |
| Power Source | Uses standard 312 zinc air 1.4V hearing aid
battery | Uses standard zinc air 1.4V hearing aid battery |
| Quality
Assurance
Standard | ANSI S3.22-2003 to ensure proper
functioning of HA | ANSI 3.21-2003 to ensure proper functioning of
HA |
Information required under Title 21, Section 8743400, and not already provided 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 intensity. (OSHA Regulations (Standard - 29 CFR 1910.95 Occupational Noise Exposures))
Hearing Healthcare Professional Diagnosis
The sale and fitting of the switch 8 TRT will only be conducted through a Hearing Healthcare Professional, such as an audiologist, hearing aid specialist or otolaryngologists.
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Benefits
Relief of tinnitus symptoms may be provided by the switch 8 TRT when utilized with appropriate counselling and tinnitus retraining 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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 2 2009
AUDIFON USA C/O Jane Perrone Vice President of U.S. Operations 403 Chairman Court, Suite 1 Debary, FL 32713
Re: K091552
Trade/Device Name: switch TRT and switch 8 TRT Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW, ESD Dated: May 22, 2009 Received: May 27, 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
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.
5
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
R. k. him
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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4. Indications for Use Statement
K091552 510(k) Number (if known):
audifon switch TRT Device Name:
Indications for Use:
The switch TRT is addressed to the adult population with a chronic persistent ringing in the ears (Timitus), 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 sufficient bandwidth and intensity and is applied on the ear.
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yames R. Kane, Ph.D.
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091552
7
4. Indications for Use Statement
K091552 510(k) Number (if known):
audifon switch 8 TRT Device Name:
Indications for Use:
The switch 8 TRT is addressed to the adult population with a chronic persistent ringing in the ears (Timitus), who also need or desire amplification. The amplification suits the needs of a mild to a moderate hearing loss.
to a nower its 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 sufficient bandwidth and intensity and is applied on the ear.
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yama K. Rama, Ph.D.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091552
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