SWITCH TRT

K091552 · Audifon GmbH & Co. KG · KLW · Aug 12, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K091552
• Device Name: SWITCH TRT
• Applicant: Audifon GmbH & Co. KG
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Aug 12, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Digital noise generator and hearing aid; housed in receiver-in-the-ear instrument. Inputs: ambient sound (for amplification) and internal broadband noise generation. Operation: generates broadband noise for tinnitus masking/distraction; provides amplification for hearing loss. Programmable via audifit software and HI-PRO box; features four programs with adjustable noise shape (low-cut/high-cut filters) and output levels. Used by hearing healthcare professionals (audiologists/specialists) to fit devices for patients. Output: broadband noise and amplified sound delivered to ear. Benefit: tinnitus symptom relief via masking/distraction therapy. Context: prescribed by professional; used by patient in daily life.

Clinical Evidence

Bench testing only. Device performance verified against ANSI S3.22-2003 standards for hearing aids. No clinical data presented.

Technological Characteristics

Digital circuit; receiver-in-the-ear housing; 1.4V zinc air 312 battery. Broadband noise generation; low-cut/high-cut filters. Programmable via HI-PRO interface. ANSI S3.22-2003 compliant. Maximum output 100 dB SPL (fixed at 80 dB); frequency range 200-6000 Hz.

Indications for Use

Indicated for adults with chronic persistent tinnitus, with or without mild-to-moderate hearing loss, participating in a tinnitus management program.

Regulatory Classification

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.

Special Controls

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.

Predicate Devices

• Siemens TCI Combi (K003558)

Submission Summary (Full Text)

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### 510(k) Summary

AUG 12 2009

# K091552

AUG 1

1. Applicant's Name and Address:

audifon USA Inc. 403 Chairman Ct., Suite 1 Debary, Florida 32713 PO BOX 531700 USA

2. Contact Person: Jane E Perrone Phone: [phone]

3. Trade or Proprietary Name:

4. 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:

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<br>program | Mask tinnitus as part of tinnitus management<br>program |
| Indications For<br>Use | chronological persistent ringing in the ears,<br>Tinnitus patients with or without a hearing<br>loss | Tinnitus patients with or without a hearing loss |
| Target<br>Population | Adults with tinnitus that are participating in a<br>tinnitus management program | Adults and children (≥ 5 years) with tinnitus<br>that are participating in a tinnitus management<br>program |

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| Operation /<br>Mechanism | Uses broadband noise; Manages tinnitus<br>through masking and distraction<br>Circuit type: Digital<br>Programmable: Yes<br>Available noises: Four<br>Volume control: No<br>white-noise is adjustable<br>noise level is programmable<br>adjustable Low Battery Indicator<br>programmable Program Switch Tones | Uses broadband noise; Manages tinnitus<br>through masking and distraction<br>Circuit type: Digital<br>Programmable: Yes<br>Available noises: Four<br>Volume control: Yes<br>Volume Control Range:<br>Programmable: OFF, 8 dB, 16 dB, 32 dB |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Where Used | May be used anywhere | May be used anywhere |
| Physical<br>Description | Standard receiver-in-the-ear instrument<br>housing | Standard behind-the-ear instrument housing |
| Maximum<br>Output<br>Characteristics | RMS Output Characteristics:<br>White noise: 100 dB SPL<br>(maximum output fixed at 80dB)<br>frequency range: 200 - 6000 Hz | RMS Output Characteristics:<br>White noise: 102 dB SPL |
| Power Source | Uses standard 312 zinc air 1.4V hearing aid<br>battery | Uses standard zinc air 1.4V hearing aid battery |
| Quality<br>Assurance<br>Standard | ANSI S3.22-2003 to ensure proper<br>functioning of HA | ANSI 3.21-2003 to ensure proper functioning of<br>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.

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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 [phone] or [phone] 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

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