AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S

K130417 · Audifon-USA, Inc. · KLW · Sep 12, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K130417
• Device Name: AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
• Applicant: Audifon-USA, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Sep 12, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Digital noise generators; provide broadband noise for tinnitus masking/distraction. Input: none (generates internal noise signal). Processing: digital signal generation; programmable noise shape (low/high-cut filters) and output level via audifit software and HI-PRO interface. Output: broadband noise delivered to ear. Used in clinic or home; operated by patient under professional guidance. Sueno T models include three trimmer potentiometers for manual adjustment by professional. Healthcare provider uses output to facilitate TRT protocol; benefits patient by masking tinnitus symptoms.

Clinical Evidence

Bench testing only. Performance verified according to ANSI S3.22-2009 standards. Testing confirmed acoustic characteristics, frequency range (200-8000 Hz), and output levels are comparable to the predicate device and safe for TRT application.

Technological Characteristics

Digital noise generator; ITE (CIC) or BTE (S) housing. Powered by zinc-air batteries (size 10 or 312). Programmable via HI-PRO and audifit software. Features low/high-cut filters for noise shaping. Sueno T models include manual trimmer potentiometers. Complies with ANSI S3.22-2009.

Indications for Use

Indicated for adults with chronic persistent tinnitus who do not require or desire amplification. Used for tinnitus masking as part of Tinnitus Retraining Therapy (TRT) under the guidance of a licensed hearing healthcare professional or audiologist.

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

• audifon switch TRT (K091552)

Submission Summary (Full Text)

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K130417

- 5 510(k) Summary
1.

2.

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: [phone]

SEP 12 2013

3. Trade or Proprietary Name: audifon sueno CIC audifon sueno S audifon sueno T CIC audifon sueno T S

4. Device Common Name / Classification Name:

Tinnitus Masker (Regulation Number: 21 CFR 874.3400)

ર્જ Product Code: KLW

6. Classification of Device: Class II for tinnitus masker

- 7. 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

10. Date of Preparation July18, 2013

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# 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:

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| | audifon sueño CIC<br>audifon sueño S<br>audifon sueño T CIC<br>audifon sueño T S | audifon switch: TRT |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For<br>Use | The devices are intended for the adult population<br>suffering from a chronic persistent ringing in the<br>ears (Tinnitus), who do not need or desire<br>amplification. The products may be used for<br>masking Tinnitus as part of a Tinnitus Retraining<br>Therapy (TRT) protocol and should be utilized<br>only in consultation with a licensed hearing<br>healthcare professional, who is trained in<br>subsequent rehabilitation therapy, or a qualified<br>audiologist. | The device is addressed to the adult population<br>with a chronic persistent ringing in the ears<br>(Tinnitus), who do not need or desire<br>amplification. It may be used for masking tinnitus<br>as part of tinnitus management program that is<br>prescribed by a licensed hearing healthcare<br>professional, who is trained in subsequent<br>rehabilitation therapy, or a qualified audiologist.<br>Therefore it generates a broadband noise with<br>sufficient bandwidth and intensity and is applied<br>on the ear. |
| Operation /<br>Mechanism | Uses broadband noise; Manages tinnitus through<br>masking and distraction<br>Circuit type:<br>Digital<br>Programmable:<br>Yes<br>Available noises:<br>One<br>Volume control:<br>Yes | Uses broadband noise; Manages tinnitus through<br>masking and distraction<br>Circuit type:<br>Digital<br>Programmable:<br>Yes<br>Available noises:<br>Four<br>Volume control:<br>No |
| | white-noise is adjustable<br>noise level is programmable<br>adjustable Low Battery Indicator | white-noise is adjustable<br>noise level is programmable<br>adjustable Low Battery Indicator<br>programmable Program Switch Tones |
| Where Used | May be used anywhere | May be used anywhere |
| Physical<br>Description | Standard In-the-ear instrument housing<br>(CIChousing)<br>Standard behind-the-ear instrument housing<br>(S housing) | Standard receiver-in-the-ear instrument housing |
| Maximum<br>Output<br>Characteristics | RMS Output Characteristics: | RMS Output Characteristics: |
| | White noise:<br>sueno CIC 70 dB SPL<br>sueno S 92 dB SPL<br>sueno T CIC 71 dB SPL<br>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<br>(CIC housing)<br>standard 312 zinc air 1,4V hearing aid battery<br>(S housing) | Uses standard 312 zinc air 1.4V hearing aid<br>battery |
| Quality<br>Assurance | ANSI S3.22-2009 to ensure proper functioning of<br>HA | ANSI S3.22-2009 to ensure proper functioning of<br>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

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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 [phone] or [phone] 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 [phone] or [phone] 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_________________________________________________________________________________________________________________________________________________________________