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.

Device Description

The audifon sueno devices are digital noise generators which were developed to be used in a tinnitus 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 instrument housing (CIC housing) or in a standard behind-the-ear instrument housing (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.

AI/ML Overview

The provided document does not describe a study that establishes acceptance criteria for the audifon sueno devices, nor does it provide performance data from such a study. Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (audifon switch TRT, K091552).

Therefore, I cannot fill in the requested table and answer many of the questions directly. However, I can extract information related to the comparison with the predicate device, which serves as the basis for deeming the new device safe and effective.

Here's a summary based on the provided text:

Basis for Acceptance: The audifon sueno devices were accepted based on their substantial equivalence to the predicate device, audifon switch TRT (K091552). This means the FDA determined that the new devices are as safe and effective as the predicate device, and perform as well. This determination relies on comparing design, materials, intended use, targeted population, and non-clinical performance data (acoustic characteristics).

Key Information from the Document:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the substantial equivalence comparison):

It's important to note that the "acceptance criteria" here are not a set of predefined performance thresholds for a clinical study. Instead, they are the characteristics and performance aspects compared to the predicate device for demonstrating substantial equivalence. The "reported device performance" refers to the characteristics of the new device that align with or are justified against the predicate.

Characteristic / "Acceptance Criteria" (Compared to Predicate)	Audifon Sueno Devices (Reported Performance/Characteristics)	Audifon Switch TRT (Predicate Device Characteristics)
Intended 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 (white-noise is adjustable, noise level is programmable, adjustable Low Battery Indicator).	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).
Physical Description	Standard In-the-ear instrument housing (CIC housing); Standard behind-the-ear instrument housing (S housing).	Standard receiver-in-the-ear instrument housing.
Maximum Output Characteristics (RMS)	White noise: sueno CIC 70 dB SPL, sueno S 92 dB SPL, sueno T CIC 71 dB SPL, sueno T S 72 dB SPL. (Note: "The lower maximum output has no influence on the effectiveness of the devices" because only levels below 80 dB SPL are needed for TRT, and OSHA limits are 85 dBA.	White noise: 100 dB SPL
Frequency Range	200 - 8000 Hz	200 - 6000 Hz (Note: "The frequency range provides an equivalent white noisewith the same sound quality.")
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.
Similarity Conclusion	Similar acoustic characteristics, similar style (ITE or BTE), similar material, similar intended use, same targeted population.	(Basis for comparison)

Regarding the Study Details:

The provided text describes a non-clinical performance data study to verify that the sueno devices have similar effectiveness to the predicate device, specifically measuring according to ANSI S3.22-2009. This is a standalone (algorithm only without human-in-the-loop performance) type of evaluation focusing on technical specifications rather than user interaction or clinical outcomes.

2. Sample size used for the test set and the data provenance: Not applicable. This was a non-clinical, technical performance test of the device's acoustic characteristics according to a standard, not a clinical study with a test set of human subjects or data. The data provenance would be from laboratory measurements in Germany (where audifon GmbH & Co. KG is located).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical dataset is not relevant to this type of non-clinical, technical performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was done. The device is a tinnitus masker, not an AI diagnostic tool for "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, a standalone (non-clinical, technical performance) evaluation was done to measure acoustic characteristics according to ANSI S3.22-2009.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical performance test, the "ground truth" would be the specifications and requirements defined by the ANSI S3.22-2009 standard for hearing aids. The device's measured acoustic characteristics were compared against these standards and the known characteristics of the predicate device.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary: The acceptance of the audifon sueno devices was based on a demonstration of substantial equivalence to an existing predicate device (audifon switch TRT) through non-clinical performance testing (acoustic characteristics measurement according to ANSI S3.22-2009) and comparison of their intended use, design, and materials. No clinical studies involving human subjects or AI performance evaluations against expert-established ground truth were performed or referenced in this 510(k) summary.

Summary

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K130417

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

1. 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

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Indications for Use

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:

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	audifon sueño CICaudifon sueño Saudifon sueño T CICaudifon sueño T S	audifon switch: TRT
Indication ForUse	The devices are intended for the adult populationsuffering from a chronic persistent ringing in theears (Tinnitus), who do not need or desireamplification. The products may be used formasking Tinnitus as part of a Tinnitus RetrainingTherapy (TRT) protocol and should be utilizedonly in consultation with a licensed hearinghealthcare professional, who is trained insubsequent rehabilitation therapy, or a qualifiedaudiologist.	The device is addressed to the adult populationwith a chronic persistent ringing in the ears(Tinnitus), who do not need or desireamplification. It may be used for masking tinnitusas part of tinnitus management program that isprescribed by a licensed hearing healthcareprofessional, who is trained in subsequentrehabilitation therapy, or a qualified audiologist.Therefore it generates a broadband noise withsufficient bandwidth and intensity and is appliedon the ear.
Operation /Mechanism	Uses broadband noise; Manages tinnitus throughmasking and distractionCircuit type:DigitalProgrammable:YesAvailable noises:OneVolume control:Yes	Uses broadband noise; Manages tinnitus throughmasking and distractionCircuit type:DigitalProgrammable:YesAvailable noises:FourVolume control:No
	white-noise is adjustablenoise level is programmableadjustable Low Battery Indicator	white-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones
Where Used	May be used anywhere	May be used anywhere
PhysicalDescription	Standard In-the-ear instrument housing(CIChousing)Standard behind-the-ear instrument housing(S housing)	Standard receiver-in-the-ear instrument housing
MaximumOutputCharacteristics	RMS Output Characteristics:	RMS Output Characteristics:
	White noise:sueno CIC 70 dB SPLsueno S 92 dB SPLsueno T CIC 71 dB SPLsueno 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 aidbattery
QualityAssurance	ANSI S3.22-2009 to ensure proper functioning ofHA	ANSI S3.22-2009 to ensure proper functioning ofHA

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

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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

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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

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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_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.