(205 days)
Not Found
No
The device description focuses on standard digital noise generation and manual programming by a healthcare professional, with no mention of AI or ML capabilities.
Yes
The device is described as a "noise generator" specifically developed for "Tinnitus Retraining Therapy (TRT)" to mask Tinnitus, which directly addresses a medical condition (chronic persistent ringing in the ears).
No
This device is a digital noise generator intended for masking tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it is housed in standard In-the-ear or Behind-the-ear instrument housings, 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 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 described device is a digital noise generator intended to be worn in or behind the ear to help manage tinnitus (ringing in the ears) through masking and as part of a therapy protocol. It does not analyze any biological samples.
- Intended Use: The intended use is for managing a symptom (tinnitus) through sound therapy, not for diagnosing a disease or condition based on biological markers.
Therefore, the device falls under the category of a medical device, specifically an audiologic device, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. 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 licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
Product codes
KLW
Device Description
The audifon sueno devices aredigital noise generatorswhich were developed to be used in a tionitus retraining therapy. These products have one program, 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 audifit software. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrumenthousing (CIC housing) or in a standard behind-the-ear instrumenthousing (S housing).
The audifon sueno T devices (sueno T S and sueno T CIC) can be additional adjusted with three trimmer potentiometers by the hearing healthcare professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ears
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)
The non-clinical performance data which were measured according to official standards (ANSI S3.22-2009) verify that the sueno devices have a similar effectiveness as the predicate device. For TRT therapy only low sound levels below 80 dB SPL are needed. So for an effective TRT system levels above this are not needed. Also according the OSHA (29CFR 1910.95) output levels should not exceed 85 dBA. Therefore a warning in the software will occur that the higher levels 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 noisewith the same sound quality.
In conclusion the non-clinical tests demonstrate that the audifon sueno devices are as safe, as effective, and perform as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091552 audifon switch TRT
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
audifon USA Inc. · Applicant's Name and Address: 403 Chairman Ct., Suite 1 Debary, Florida 32713 PO BOX 531700 USA Jane E Perrone Contact Person: Phone: 386-6688812
SEP 12 2013
-
Trade or Proprietary Name: audifon sueno CIC audifon sueno S audifon sueno T CIC audifon sueno T S
-
Device Common Name / Classification Name:
Tinnitus Masker (Regulation Number: 21 CFR 874.3400)
ર્જ Product Code: KLW
- Classification of Device: Class II for tinnitus masker
-
- Establishment Registration Number:
8. Address of Manufacturing Site:
3005384855
audifon GmbH & Co. KG Werner-von-Siemens.Str. 2 D-99625 Kölleda Germany
Market Device with 9. Substantial Equivalence: K091552 audifon switch TRT
- Date of Preparation July18, 2013
1
Indications for Use
The devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. 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 licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
Description of Device
The audifon sueno devices aredigital noise generatorswhich were developed to be used in a tionitus retraining therapy. These products have one program, 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 audifit software. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrumenthousing (CIC housing) or in a standard behind-the-ear instrumenthousing (S housing).
The audifon sueno T devices (sueno T S and sueno T CIC) can be additional adjusted with three trimmer potentiometers by the hearing healthcare professional.
Comparison Information to Predicate Device
The audifon sueno devices are substantially equivalent to the audifon switchTRT (K091552). The audifon sueno devices and the audifon switch TRT are fully digital noiser, with programmable noises. Within the program the level and the shape of the noise can be adjusted. Also the audifon sueno devices and the switch TRTcan 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 S3.22-2009) verify that the sueno devices have a similar effectiveness as the predicate device. For TRT therapy only low sound levels below 80 dB SPL are needed. So for an effective TRT system levels above this are not needed. Also according the OSHA (29CFR 1910.95) output levels should not exceed 85 dBA. Therefore a warning in the software will occur that the higher levels 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 noisewith the same sound quality.
In conclusion the non-clinical tests demonstrate that the audifon sueno devices are as safe, as effective, and perform as well as the predicate device.
The submission for timitus 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:
2
| | audifon sueño CIC
audifon sueño S
audifon sueño T CIC
audifon sueño T S | audifon switch: TRT |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For
Use | The devices are intended for the adult population
suffering from a chronic persistent ringing in the
ears (Tinnitus), who do not need or desire
amplification. 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 licensed hearing
healthcare professional, who is trained in
subsequent rehabilitation therapy, or a qualified
audiologist. | The device is addressed to the adult population
with a chronic 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
sufficient bandwidth and intensity and is applied
on the ear. |
| Operation /
Mechanism | Uses broadband noise; Manages tinnitus through
masking and distraction
Circuit type:
Digital
Programmable:
Yes
Available noises:
One
Volume control:
Yes | 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 | 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
(CIChousing)
Standard behind-the-ear instrument housing
(S housing) | Standard receiver-in-the-ear instrument housing |
| Maximum
Output
Characteristics | RMS Output Characteristics: | RMS Output Characteristics: |
| | White noise:
sueno CIC 70 dB SPL
sueno S 92 dB SPL
sueno T CIC 71 dB SPL
sueno T S 72 dB SPL | White noise: 100 dB SPL |
| | frequency range: 200 - 8000 Hz | frequency range: 200 - 6000 Hz |
| Power Source | standard 10 zinc air 1,4V hearing aid battery
(CIC housing)
standard 312 zinc air 1,4V hearing aid battery
(S housing) | Uses standard 312 zinc air 1.4V hearing aid
battery |
| Quality
Assurance | ANSI S3.22-2009 to ensure proper functioning of
HA | ANSI S3.22-2009 to ensure proper functioning of
HA |
The following table compares the audifon sueno devices and the audifon switch TRT.
Conclusion
- The sueno devices have similar acoustic characteristics as the predicate device. 0
- The sueno devices are similar in style (ITE or BTE) as the predicate device. o
- The sueno devices are similar in material as the predicate device. o
- The sueno devices are similar in intended use as the predicate device �
- The sueno devices have the same targeted population as the predicate device o
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
September 12, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshife Avenue Document Control Center - WO66-G60 Silver Spring, MI) 20993-0002
audifon-USA. Inc. % Ms. Jane Perrone V.P. of U.S. Operations 403 Chairman Court. Suite 1 DeBary, FL 32713
Re: K130417 Trade/Device Name: audifon sueno S audifon sucno CIC audifon sucno T S audifon sueno T CIC Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: August 13. 2013 Received: August 14. 2013
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. Please note: CDRH does not evaluate information related to contract fiability 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.
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
4
Page 2 - Ms. Jane Perrone
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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,
Eric A Mann -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
5
4 Indications for Use Statement
510(k) Number (if known): K130417
Device Name: audifon sueno CIC (TRT noise generator) audifon sueno S (TRT noise generator) audifon sueno T CIC (TRT noise generator) audifon sueno T S (TRT noise generator)
Indications for Use:
The devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Timitus), who do not need or desire amplification. The products may be used for masking Tinnitus as part of a Timitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
Prescription Use X (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)
Cherish R. Giusta 2013.09.11 09:48 27-04'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________