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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the audifon switch 8 TRT personal sound amplifier. This document focuses on demonstrating substantial equivalence to a predicate device (Siemens TCI Combi, K003558), rather than proving the device meets a specific set of quantitative acceptance criteria through a clinical study.

Therefore, the requested information for acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from this document as it describes a device comparison rather than a performance study.

Here's a breakdown of what can be inferred from the document regarding "acceptance" in the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not explicit performance metrics for the device itself, but rather the features and performance parity with the predicate device. The "reported device performance" is a comparison to the predicate.

Feature/Criterion (Acceptance in context of Substantial Equivalence)	audifon switch 8 TRT Performance (as reported)	Predicate Device (Siemens TCI Combi, K003558) Performance
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; also need or desire amplification for mild to moderate hearing loss	Tinnitus patients with or without a hearing loss (Predicate does not explicitly mention "need or desire amplification")
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 (Note: Predicate includes children, which is a broader claim)
Operation / Mechanism	Uses broadband noise; Manages tinnitus through masking and distraction; Digital; Programmable (4 noises); white-noise adjustable; noise level programmable; etc.	Uses broadband noise; Manages tinnitus through masking and distraction; Digital; Programmable (4 noises); Volume control (Yes, programmable OFF, 8 dB, 16 dB, 32 dB)
Physical Description	Standard receiver-in-the-ear instrument housing	Standard behind-the-ear instrument housing (Note: Different physical form factor, but both are "standard")
Maximum Output Characteristics (White noise)	100 dB SPL (maximum output fixed at 80dB); Frequency range: 200 - 6000 Hz	102 dB SPL
Power Source	Standard 312 zinc air 1.4V hearing aid battery	Standard zinc air 1.4V hearing aid battery
Quality Assurance Standard	ANSI S3.22-2003	ANSI 3.21-2003
Risk to Health	No more risk than conventional hearing aid or tinnitus masker; cannot deliver damaging sound intensity (OSHA Regs 29 CFR 1910.95)	(Implied safe, as it's a marketed predicate)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This document does not describe a clinical performance study with a test set of data. It relies on a comparison of device specifications and intended use.
Data Provenance: Not applicable. The data presented is a comparison of product specifications, not clinical trial data. The device itself is manufactured in Kölleda, Germany.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. No ground truth for a test set was established as part of this submission. The FDA evaluates the substantial equivalence claim based on the provided technical and descriptive information.
Qualifications: Not applicable.

4. Adjudication Method

Adjudication Method: Not applicable. No clinical data required adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, there is no mention of an MRMC comparative effectiveness study. This submission is for a device with a different mechanism of action than typical AI-assisted diagnostic tools. It's a tinnitus masker/hearing aid, not a diagnostic imaging device.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No, there is no mention of a standalone performance study. The device is a physical instrument, not an algorithm being tested in isolation.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. The "ground truth" in this context is the FDA's acceptance of the predicate device's safety and effectiveness and the demonstration that the new device is substantially equivalent in its design, function, and intended use.

8. Sample Size for the Training Set

Sample Size: Not applicable. The device is a hardware product, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable. No training set for an algorithm was used.

Summary

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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

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Description of Device

audifon switch 8 TRT Device Name:

Indications for Use:

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 managementprogram	Mask tinnitus as part of tinnitus managementprogram
Indications ForUse	chronological persistent ringing in the ears,Tinnitus patients with or without a hearingloss	Tinnitus patients with or without a hearing loss
TargetPopulation	Adults with tinnitus that are participating in atinnitus management program	Adults and children (≥ 5 years) with tinnitusthat are participating in a tinnitus managementprogram

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Operation /Mechanism	Uses broadband noise; Manages tinnitusthrough masking and distractionCircuit type: DigitalProgrammable: YesAvailable noises: FourVolume control: Nowhite-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones	Uses broadband noise; Manages tinnitusthrough masking and distractionCircuit type: DigitalProgrammable: YesAvailable noises: FourVolume control: YesVolume Control Range:Programmable: OFF, 8 dB, 16 dB, 32 dB
Where Used	May be used anywhere	May be used anywhere
PhysicalDescription	Standard receiver-in-the-ear instrumenthousing	Standard behind-the-ear instrument housing
MaximumOutputCharacteristics	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 aidbattery	Uses standard zinc air 1.4V hearing aid battery
QualityAssuranceStandard	ANSI S3.22-2003 to ensure properfunctioning of HA	ANSI 3.21-2003 to ensure proper functioning ofHA

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.

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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

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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

Page 1 of 1

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.